Miles Hutchinson

How to Design and Implement Outstanding KPI Performance Dash

Grab a cup of coffee and join us to learn how to improve your KPI focus, and juice up virtually every facet of your organization's operations from marketing, to finance, to HR, to customer service and sales. Ensure your Performance Dashboards are crisp, attention grabbing and clearly identify significant performance trends. Know whether your business is meeting or exceeding its goals with your early warning system of leading and trailing performance indicators.

Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $74.5.  $149.00 | View Details
Gina Reo

Developing an Environmental Monitoring Program Satisfying FDA's Listeria Monocytogenes

FSMA (Food Safety Modernization Act) requires organizations to assess risks, enact Preventative Controls to mitigate these risks and minimize Food Safety Hazards for consumers.

Speaker: Gina Reo | View Anytime | Duration: 60 Minutes | Price: $599.00 | View Details
Tom Fragale

ChatGPT for Excel

This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel, like basic navigation and data import/export

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

ChatGPT for Excel

This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel, like basic navigation and data import/export

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Meredith Crabtree

Performance of Root Cause Analysis, CAPA, and Effectiveness Checks

This comprehensive course offers essential knowledge and practical skills in root cause analysis, corrective and preventive actions (CAPA), and conducting effectiveness checks.

Speaker: Meredith Crabtree | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Meredith Crabtree

SOPs - How to Write Them to Satisfy Those Inspectors

Attending this training will help the participant understand the specific requirements and expectations of FDA inspectors, allowing them to develop SOPs that meet regulatory standards and demonstrate compliance.

Speaker: Meredith Crabtree | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Meredith Crabtree

The Most Common FDA Observations and Prevention Strategies

In the tightly regulated landscape of FDA-controlled industries, successful navigation through inspections is a cornerstone of organizational success.

Speaker: Meredith Crabtree | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Meredith Crabtree

The FDA and Cosmetic Oversight - What does that look like?

"The FDA and Cosmetic Oversight - What does that look like?" is a training session aimed at providing participants with an understanding of the role of the Food and Drug Administration (FDA) in regulating cosmetics.

Speaker: Meredith Crabtree | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Michael Esposito

Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats

This webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Michael Esposito

Using a Learning Management System (LMS) to Develop Pharma Training Curricula

Learning Management Systems (LMSs) are important tools for assuring and demonstrating that Pharma employees maintain their training, and their GMP compliance, up to date. They often boast great functionality but also have limitations that must be overcome for a Pharma company to use them effectively.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Michael Esposito

Strategies To Prevent Manufacture And Distribution Of Substandard Medications

Substandard product can exist even if the product itself is manufactured according to quality standards. Harm to patients and damage to a company's reputation are the two most obvious consequences of substandard product.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Michael Esposito

The Importance of Packaging and Labeling in Pharmaceutical Product Development

Occupying a critical position in the success or failure of any pharmaceutical product launch, Packaging and Labeling form a bridge between the conception of a product and its realization and distribution.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Michael Esposito

Function, Preparation, and Execution of Job Aids in the Pharmaceutical Industry

Job aids, also known as work instructions, are documents that resemble SOPs, but their content, use and training are different than those for SOPs.

Speaker: Michael Esposito | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Michael Esposito

Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats

This webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Michael Esposito

Using a Learning Management System (LMS) to Develop Pharma Training Curricula

Learning Management Systems (LMSs) are important tools for assuring and demonstrating that Pharma employees maintain their training, and their GMP compliance, up to date. They often boast great functionality but also have limitations that must be overcome for a Pharma company to use them effectively.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Michael Esposito

Strategies to Prevent Manufacture and Distribution of Substandard Medications

Substandard product can exist even if the product itself is manufactured according to quality standards. Harm to patients and damage to a company's reputation are the two most obvious consequences of substandard product.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Michael Esposito

The Importance of Packaging and Labeling in Pharmaceutical Product Development

Occupying a critical position in the success or failure of any pharmaceutical product launch, Packaging and Labeling form a bridge between the conception of a product and its realization and distribution.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Michael Esposito

Function, Preparation, and Execution of Job Aids in the Pharmaceutical Industry

Job aids, also known as work instructions, are documents that resemble SOPs, but their content, use and training are different than those for SOPs.

Speaker: Michael Esposito | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Michael Esposito

Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats

This webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Michael Esposito

Using a Learning Management System (LMS) to Develop Pharma Training Curricula

Learning Management Systems (LMSs) are important tools for assuring and demonstrating that Pharma employees maintain their training, and their GMP compliance, up to date. They often boast great functionality but also have limitations that must be overcome for a Pharma company to use them effectively.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Michael Esposito

Strategies To Prevent Manufacture and Distribution of Substandard Medications

Substandard product can exist even if the product itself is manufactured according to quality standards. Harm to patients and damage to a company's reputation are the two most obvious consequences of substandard product.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Trends in FDA Compliance and Enforcement for Regulated Systems

FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Best Practices in Preparation for an FDA Computer System Audit

FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

We will discuss the importance of applying industry best practices when auditing a vendor of hardware, software, or other technology, or a provider of technology services, such as system implementation, system configuration, system development, system integration or similar activity.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Data Integrity and Privacy: 21 CFR Part 11, Annex 11, & General Data Protection Regulation (GDPR)

During this webinar, in addition to learning about the California privacy rules, we will discuss the Health Information Portability and Accountability Act (HIPAA) in the US and the General Data Protection Regulation (GDPR) that is in effect to protect citizens’ personal data when they reside in the European Union (EU).

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Artificial Intelligence (AI), Machine Learning, and FDA Compliance for Computer Systems and Data

As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environments where AI is becoming prevalent.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Pharma 4.0: Next Generation Technology Approach to GxP Products, Systems, Data, & FDA Compliance

So what is next for the modernization of the processes involved in compliance for FDA-regulated systems, keeping in mind the guidance documents provide thus far?

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Trial Master File (TMF)/eTMF, & FDA's Draft Guidance for Electronic Records/Signatures Used in Clinical Trials

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

GAMP®5, 2nd Edition & Alignment with FDA's Draft Guidance for Computer Software Assurance(CSA)

We'll cover in detail the differences between GAMP®5, 2nd Edition, issued in July 2022 and the original version of GAMP®5.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and the new FDA Draft Guidance

Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Medical Device Software Validation Meeting FDA Regulations

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

How to Prepare for and Host an FDA Inspection and Respond to 483's

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and the new FDA Draft Guidance

Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel Pivot Tables, Pivot Charts, Slicers, and Timelines

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel: Tips and Tricks and Shortcuts

Microsoft Excel has become the de facto spreadsheet application for business.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel PowerPivot and Power Query

If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Carolyn Troiano

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

We will discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately, in accordance with FDA's guidance.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Computer System Validation (CSV) vs. Computer System Assurance (CSA): Aligning Agile to the GAMP®5 "V" Model & System Development Life Cycle (SDLC)

Advancements in technology have forced organizations to rethink business models.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

FDA Compliance for Regulated Systems using COTS, Cloud, and SaaS Solutions

Advancements in technology have forced organizations to rethink business models.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Developing a Strategic Approach to FDA Compliance for Validation of Computer Systems

We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

2-Day Virtual Seminar on Effective Technical Writing in the Life Sciences

This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.

Speaker: Charles H. Paul | View Anytime | Duration: 2 Days | Price: $1,045.00 | View Details
Charles H. Paul

2-Day Virtual Seminar on Project Management for Non-Project Managers - PM in the Life Sciences - Pharmaceutical/ Biotechnology and Medical Devices

What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant.

Speaker: Charles H. Paul | View Anytime | Duration: 2 Days | Price: $1,045.00 | View Details
Charles H. Paul

6-Hour Virtual Seminar on FDA Audit Preparation, Inspection Conduct, and Do's and Don'ts

This seminar is broken into two phases. Phase one corresponding to Day 1 will build basic knowledge of the inspection - the who, what, and when. Phase Two will delve into the how of the inspection from the perspectives of the FDA and those being inspected.

Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Charles H. Paul

6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences

This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.

Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Charles H. Paul

6-Hour Virtual Seminar on Project Management for Non-Project Managers

What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant.

Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Charles H. Paul

6-Hour Virtual Seminar on FDA Audit Preparation

This seminar is broken into two phases. Phase one will build basic knowledge of the inspection - the who, what, and when. Phase Two will delve into the how of the inspection from the perspectives of the FDA and those being inspected.

Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Garrett Wasny

ChatGPT and Complex Financial and HR Conversations for Accountants

The course provides a concise overview of how accountants can use ChatGPT to assist with communications involving intricate and often sensitive topics that require a deep understanding of both financial principles and human resource policies. These conversations can range from budgeting and compensation to ethical considerations and regulatory compliance.

Speaker: Garrett Wasny | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Medical Device Software Validation Meeting FDA Regulations

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

How to Prepare for and Host an FDA Inspection and Respond to 483's

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and the new FDA Draft Guidance

Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel Pivot Tables, Pivot Charts, Slicers, and Timelines

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel: Tips and Tricks and Shortcuts

Microsoft Excel has become the de facto spreadsheet application for business.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel PowerPivot and Power Query

If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Medical Device Software Validation Meeting FDA Regulations

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

How to Prepare for and Host an FDA Inspection and Respond to 483's

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel Pivot Tables, Pivot Charts, Slicers, and Timelines

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel: Tips and Tricks and Shortcuts

Microsoft Excel has become the de facto spreadsheet application for business.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel PowerPivot and Power Query

If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Charles H. Paul

2-Hour Virtual Seminar on Reduce Performance Failures in Your Operations by Addressing Human Performance, Human Error, and Cognitive Effort

In today's fast-paced operational environments, organizations face challenges related to human performance, human error, and mental load. This comprehensive two-hour training program aims to equip participants with the knowledge, skills, and strategies to reduce performance failures in operations.

Speaker: Charles H. Paul | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Charles H. Paul

2-Day Virtual Seminar on Technical Writing in the Life Sciences - Writing Regulatory Documentation for Consistency, Clarity, Accuracy, and Utility

This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.

Speaker: Charles H. Paul | View Anytime | Duration: 2 Days | Price: $1,045.00 | View Details
Charles H. Paul

6-Hour Virtual Seminar on Successfully Preparing for, Conducting, and Executing an FDA Audit of your Operations

This seminar is broken into two phases. Phase One corresponding to Day 1 will build basic knowledge of the inspection - the who, what, and when. Phase Two will delve into the how of the inspection from the perspectives of the FDA and those being inspected.

Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Charles H. Paul

6-Hour Virtual Seminar on Strategic Risk Management for Medical Device Design Excellence

The 6-Hour seminar provided a comprehensive exploration of the medical device design and development process with a primary focus on the crucial aspect of risk management. In the introduction, participants gained an overview of the entire medical device design and development process, emphasizing the paramount importance of integrating effective risk management strategies.

Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Charles H. Paul

6-Hour Virtual Seminar on Project Management within the Life Sciences

What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant.

Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Robert J. Russell

6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations

This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).

Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Robert J. Russell

4-Hour Virtual Seminar on Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia, and Japan

Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated.

Speaker: Robert J. Russell | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Robert J. Russell

6-Hour Virtual Seminar on The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities

This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Tom Fragale

4-Hour Virtual Seminar on Bootcamp on Excel

In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.

Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Tom Fragale

4-Hour Virtual Seminar on Managing Large Amounts of Data with Excel Charts, Power Query, Pivot Tables, and PowerPivot

In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.

Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Mike Thomas

Excel - Mastering Lookup Functions

"How do I look up a value in list ONE and pick up a related value from list TWO"

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Lists and Tables - A Beginner's Guide to Managing List-Based Data

Often perceived as a mere number-crunching tool, Excel's true prowess lies in its capacity to organize and manage list-based data efficiently and this training session is designed to unveil Excel's full potential beyond arithmetic computations.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - A Beginner's Guide to Formulas

Excel is an essential tool for anyone who works with data, from entry-level employees to seasoned professionals. Knowing how to use Excel formulas can help you streamline your work, increase accuracy, and save time.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Essential Tips and Tricks for the New User

Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application's power.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel Basics - Data Visualization - Creating Effective Charts

"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Quick Tips to Help You be More Productive

Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.

Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Mike Thomas

Excel - Mastering Lookup Functions

"How do I look up a value in list ONE and pick up a related value from list TWO"

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Lists and Tables - A Beginner's Guide to Managing List-Based Data

Often perceived as a mere number-crunching tool, Excel's true prowess lies in its capacity to organize and manage list-based data efficiently and this training session is designed to unveil Excel's full potential beyond arithmetic computations.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - A Beginner's Guide to Formulas

Excel is an essential tool for anyone who works with data, from entry-level employees to seasoned professionals. Knowing how to use Excel formulas can help you streamline your work, increase accuracy, and save time.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Essential Tips and Tricks for the New User

Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application's power.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel Basics - Data Visualization - Creating Effective Charts

"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Quick Tips to Help You Be More Productive

Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.

Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Carolyn Troiano

4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.

Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Carolyn Troiano

6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.

Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Carolyn Troiano

4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.

Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Carolyn Troiano

6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.

Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Mike Thomas

Excel - Mastering Lookup Functions

"How do I look up a value in list ONE and pick up a related value from list TWO"

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Lists and Tables - A Beginner's Guide to Managing List-Based Data

Often perceived as a mere number-crunching tool, Excel's true prowess lies in its capacity to organize and manage list-based data efficiently and this training session is designed to unveil Excel's full potential beyond arithmetic computations.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - A Beginner's Guide to Formulas

Excel is an essential tool for anyone who works with data, from entry-level employees to seasoned professionals. Knowing how to use Excel formulas can help you streamline your work, increase accuracy, and save time.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Essential Tips and Tricks for the New User

Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.

Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Robert J. Russell

Drug Master Files: Understanding and Meeting Your Regulatory and Processing Responsibilities

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.

Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Drug Master Files: Understanding and Meeting Your Regulatory and Processing Responsibilities

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.

Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Abdelrahman Abdou

New Regular Expressions (REGEX) functions in Excel

As the volume of data we handle continues to grow exponentially, the ability to efficiently process and analyze text data becomes increasingly crucial.

Speaker: Abdelrahman Abdou | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Garrett Wasny

ChatGPT for Innovative Business Advisory Services for Accountants

The course provides a concise overview of how accounting professionals can leverage ChatGPT, OpenAI's powerful language model, to innovate and enhance their business advisory services. In plain language the presentation integrates theory and practice, and demonstrates how various enterprise evaluation methodologies can be applied in combination with ChatGPT to sharpen your business analysis and increase your organization’s efficiency, profitability, and growth

Speaker: Garrett Wasny | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Garrett Wasny

Introduction to Generative AI for Accountants

This course offers an in-depth look into Generative AI and its transformative impact on the accounting profession. At the core of Generative AI are technologies that can literally "see, speak, hear, write, and create" in multimodal contexts.

Speaker: Garrett Wasny | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Garrett Wasny

Excel & ChatGPT Synergy Masterclass: Unleashing Financial Analysis Superpowers

In today's data-driven landscape, the fusion of Excel's computational might with ChatGPT's intelligent querying transforms ordinary accounting tasks into dynamic, insightful financial analyses. This specialized masterclass unveils the power behind integrating Excel and ChatGPT, aimed at accountants, financial analysts, and business professionals eager to unlock new levels of efficiency and creativity in their financial workflows.

Speaker: Garrett Wasny | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Quality Management 101: An Enterprise Maintenance Professional's Guide

What are the basics of an enterprise maintenance-focused Quality Management System? This webinar will examine that question by means of the international standard, ISO 9001, the international standard for Quality Management Systems for all business or industrial systems worldwide.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

3-Hour Virtual Seminar on Bootcamp on Quality Management System (QMS)?

What are the basics of a Quality Management System? This webinar will examine that question by means of the international standard, ISO 9001.

Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
John E Lincoln

Understanding How Quality Management Works

What are the basics of a Quality Management System? This webinar will examine that question by means of the international standard, ISO 9001.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Quality Management Do's and Don't's

ISO 9001 is an international standard for Quality Management Systems for all business or industrial systems, and is used as such by companies worldwide.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.

Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Device Changes, FDA Changes, and the 510(k)

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

QMS 101: Quality Management System Guide

ISO 9001 is an internatioinal standard for Quality Management Systems for all business or industrial systems, and is used as such by companies worldwide.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Quality Management 101: An Enterprise Maintenance Professional's Guide

What are the basics of an enterprise maintenance-focused Quality Management System?

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

The Human Error Toolbox: A Practical Approach to Human Error

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Building GMP Excellence: A Guide to Implementing Compliant Training Programs

Training programs have evolved through time. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

The Human Error Toolbox: A Practical Approach to Human Error

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

How to Write SOPs that Avoid Human Error

Human error is known to be the primary cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

How to Write SOPs for Human Error Reduction

Human error is known to be the primary cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Human Error Reduction Techniques for Floor Supervisors

Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Controlling Human Error in the Manufacturing Floor

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Supervising a Human Error-Free Environment: You can do a Lot More than you Think

Human error is known to be the major cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

The Human Error Toolbox: A Practical Approach to Human Error

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Drug Master Files: Understanding and Meeting Your Regulatory and Processing Responsibilities

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.

Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
John E Lincoln

Quality Management Do's and Don't's

ISO 9001 is an international standard for Quality Management Systems for all business or industrial systems, and is used as such by companies worldwide.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.

Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Device Changes, FDA Changes, and the 510(K)

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Building GMP Excellence: A Guide to Implementing Compliant Training Programs

Training programs have evolved through time. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Human Error Gen - Human Error Mitigation: Strategies for Enhanced Performance

If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Optimizing Efficiency: A Comprehensive Guide to 5S Principles

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John C. Fetzer

How to Deal with Bad Results Under GLP

Assessment of the cause for a non-compliance is a structured series of branching questions. The answers to these eliminate possibilities and eventually highlight a root cause. This process is described, including roles and responsibilities, timing, and efforts at prevention.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John C. Fetzer

HPLC Analytical Method Development and Validation

Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John C. Fetzer

Analytical Method Validation Under Good Laboratory Practices - GLPs

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John C. Fetzer

The Transfer of Validated Methods

This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John C. Fetzer

How to Deal with Bad Results Under GLP

Assessment of the cause for a non-compliance is a structured series of branching questions. The answers to these eliminate possibilities and eventually highlight a root cause. This process is described, including roles and responsibilities, timing, and efforts at prevention.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John C. Fetzer

HPLC Analytical Method Development and Validation

Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John C. Fetzer

Analytical Method Validation Under Good Laboratory Practices - GLPs

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John C. Fetzer

The Transfer of Validated Methods

This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John C. Fetzer

How to Deal with Bad Results Under GLP

Assessment of the cause for a non-compliance is a structured series of branching questions.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John C. Fetzer

HPLC Analytical Method Development and Validation

Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dev Strischek

Cash Flow Projections for Long-term Lending

Financial organization extend credit to borrowers when the borrowers show the ability to repay the loans extended.

Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dev Strischek

The Credit Manager's Toolbox - Tools and Techniques for Making Sound Credit Decisions

This webinar will provide guidance on how gather information, evaluate it, and make sound credit decisions on prospective clients and existing borrowers.

Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dev Strischek

The Income Statement - What a Banker can Learn About a Borrower from Its Profit and Loss Statement

This program is designed to assist bankers, lenders, and credit professionals who want a fundamental understanding of the information that is contained in the income statement.

Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dev Strischek

The World of Global Cash Flow: Is There Enough to Cover All Debts?

Global cash flow is critical to analyzing and underwriting commercial borrowers, especially smaller, privately held firms where the owners and the company are so closely bound together that their assets, liabilities, and income are comingled.

Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dev Strischek

Key Elements in Managing and Maintaining Your Credit Administration and Credit Policy

This session by Dev Strischek is intended to provide guidance on how to develop and maintain a Credit Administration (CA) function that will provide guidance to anyone involved in the credit function of the bank. The session also highlights the safeguards to manage the bank’s loan portfolio in a safe and sound manner.

Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dev Strischek

C for Yourself: The 5 C's of Credit

The first four C's-capacity, conditions, collateral, and character- evaluate a borrower's ability to repay, but character forces the lender to examine closely the borrower's willingness to repay.

Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dev Strischek

Part 2- How to Write More Effective Emails - Improving Your E-Communication Skills

Emails are a core business communication tool. The speed and volume of email have dramatically changed business communication. The not-so-old standards for professional correspondence have changed and will continue to do so. Employees need to know the best strategies to communicate effectively. An effective business email is easily understood, but it is not so easily written.

Speaker: Dev Strischek | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dev Strischek

Part 1- How to Write Right for Better Business Communication

Good leaders walk the talk, but they also “write right”. They know how to say in a few words what needs to be said in crisp, clear language. The road to bad communication is paved with good intentions but poor construction. Readers know when subjects and verbs don’t agree when punctuation misses the point when words don’t fit, and content is confusing. In this session, learn how a few basic rules on grammar, punctuation, and usage can improve business written communications with clearer, more succinct content.

Speaker: Dev Strischek | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dev Strischek

Cash Flow Analysis Of Borrower’s Repayment Ability

There is an old saying in credit analysis, "Borrowers pay back loans from cash flow, not profits." But it is not just cash flow; it is cash flow from operations that is the most desirable source of repayment because it is generated by a borrower managing its working capital assets and earning a sustainable profit.

Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dev Strischek

Credit Risk Management - Principles and Practices, Tools and Techniques

Credit Risk Management is the function that ensures the organization is balancing its risk appetite with its risk tolerance to attain the organization’s desired credit risk objectives. This course provides guidance on how to implement and maintain the desired level of credit risk management with practical tools and techniques.

Speaker: Dev Strischek | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Abdelrahman Abdou

Using Images in Pivot tables for Better Data Visualization

Are you looking to elevate your Excel skills and create more engaging and visually appealing reports?

Speaker: Abdelrahman Abdou | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Abdelrahman Abdou

What If Analysis Tools in Excel: Goal Seek, Solver, and Data table

Attending this webinar will equip you with practical skills to leverage Excel's powerful What If Analysis tools Goal Seek, Solver, and Data Table.

Speaker: Abdelrahman Abdou | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

PowerPoint Creating & Presenting a Complete Slide Show

From animations and video, through to organisation charts and process flows, PowerPoint is your complete presentation graphics package providing everything you need for communicating information in an engaging and professional format.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

ChatGPT for Excel Intermediate Masterclass

Harness the awesome power of AI to take Excel to a new level and boost your efficiency working smarter and faster.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

ChatGPT for Excel Essentials Made Easy

Gain easy-to-understand and practical "hands-on" knowledge of ChatGPT and Artificial Intelligence (AI) with a focus on significantly enhancing capabilities in Microsoft Excel.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Excel Lookup Functions Xlookup & Error Suppression

Going “beyond the basics” Ray Evans clearly demonstrates, features and functionality that enhance the power and flexibility of lookup functions at intermediate level.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Outlook Email Calendar & Contacts Essentials Masterclass

Microsoft Outlook is the powerhouse in managing email, appointments, tasks and contacts.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Pivot Table Essentials for Data Analytics in Excel

A PivotTable displays a summary of a selected data set in a condensed format of rows, columns, data fields, and pages. These components can be "pivoted" with your mouse allowing you to expand, isolate, calculate, and group the particular data in real time. This table empowers the user to view and analyze large amounts of information.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Abdelrahman Abdou

Understand the Different Contexts in DAX, The Filter Context vs The Row Context in DAX

Unlock the full potential of your data with our upcoming seminar on understanding row context versus filter context in DAX, tailored for Power BI users.

Speaker: Abdelrahman Abdou | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Abdelrahman Abdou

GROUPBY and PIVOTBY Functions, Pivot Table Killers?

Unlock the full potential of Excel with our deep-dive webinar into the newly introduced GROUPBY and PIVOTBY functions.

Speaker: Abdelrahman Abdou | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Abdelrahman Abdou

10 Advanced Pivot Table Tricks that will Take Your Excel Game to the Next Level - Part 2

Back by popular demand! Join us for another deep dive into the powerful world of Excel Pivot Tables with our next webinar, "Excel Mastery: 10 More Advanced Pivot Table Tricks."

Speaker: Abdelrahman Abdou | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
John E Lincoln

6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations

This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).

Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
John E Lincoln

6-Hour Virtual Seminar on GCP/GLP/GMP: Comparison and Understanding of the FDA's 3 Major Regulations

The Good Laboratory Practice regulations describe the minimal standards for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by FDA or EPA such as animal food additives, human and animal drugs, medical devices for human use, biological products, electronic products, or pesticide products.

Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
John E Lincoln

4-Hour Virtual Seminar on Combination Product Device Supplier Management Training

There has been a major shift in the emphasis of U.S. FDA requirements for supplier CGMP compliance.

Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Robert J. Russell

6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations

This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).

Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Robert J. Russell

4-Hour Virtual Seminar on Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia, and Japan

Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated.

Speaker: Robert J. Russell | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
John E Lincoln

Device Changes, FDA Changes, and the 510(k)

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Post-Market Surveillance And Project Management Ensuring Long-term Success

This 90-minute webinar delves into the critical intersection of post-market surveillance and project management, providing professionals across industries with comprehensive insights into ensuring long-term success.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

FDA Best Audit Practices - Do's And Don'ts

This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Human Error Risk Management In Medical Device Design

The topic delves into the critical interplay between human factors, design processes, and patient safety within the realm of healthcare technology. It begins by elucidating the multifaceted nature of human errors, encompassing cognitive, perceptual, and physical aspects, and underscores their potential impact on patient well-being.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Training Strategies To Reduce Human Error In Drug Manufacturing

The webinar on offers a comprehensive exploration of the pivotal strategies aimed at minimizing errors in one of the most critical sectors of the pharmaceutical industry. The introductory segment sets the stage by emphasizing the paramount importance of error reduction in drug manufacturing for ensuring product safety, efficacy, and regulatory compliance.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management For Non-Project Managers - How To Communicate Project Actions And Progress - Conducting Effective Project Review Meetings

This webinar is about effective communication inside and outside of the project team. The webinar will use case studies and examples to reinforce key teaching points. Instruction will begin with a discussion of the communication model and the barriers that can erect obstacles to understanding the information and intent of the communications sent and received.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Role Of Cognitive Load In Medical Device Design And Human Error Prevention

The webinar delves into the critical nexus between healthcare technology and user performance. The 90-minute session begins with an exploration of cognitive load, dissecting its intrinsic, extraneous, and germane components

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - Determining the Work that needs to be done

This webinar will walk the participant through the entire process of decomposing a project's tasks into workable schedulable elements called work packages.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - Scheduling your Project

This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project's objectives.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Human Factors Engineering in Medical Device Design

This 90-minute webinar will delve into the fundamental aspects of HFE, emphasizing its pivotal role in enhancing safety, efficiency, and overall user experience within the medical device landscape.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Cybersecurity Challenges in Medical Device Technology

Many companies don't even think about the TPP until they are writing the BLA; by then it has exhausted its useful life.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.

Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Edwin Waldbusser

How to Prepare for and Host an FDA Inspection and Respond to 483's

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Validation of Artificial Intelligence (AI), Machine Language (ML), and other Superintelligence-Based Systems Regulated by FDA

During the webinar, we will discuss FDA's considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways difficult to foresee.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

3-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.

Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Carolyn Troiano

Risk-Based Approach to IT Infrastructure Qualification, Compliance & Control

We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Mastering Lookup Functions

"How do I look up a value in list ONE and pick up a related value from list TWO"

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.

Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Tom Fragale

4-Hour Virtual Seminar on Bootcamp on Excel

In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.

Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Tom Fragale

4-Hour Virtual Seminar on Managing Large Amounts of Data with Excel Charts, Power Query, Pivot Tables, and PowerPivot

In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.

Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Tom Fragale

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel: Tips and Tricks and Shortcuts

Microsoft Excel has become the de facto spreadsheet application for business.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel Pivot Tables, Pivot Charts, Slicers, and Timelines

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Ginette Collazo

The Human Error Toolbox: A Practical Approach to Human Error

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

How to Write SOPs that Avoid Human Error

Human error is known to be the primary cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Justin Muscolino

Fair Debt Collection Practices Act (FDCPA)

During this webinar, Justin will discuss an overview of the FDCPA, history, provisions, recent updates and how it came about. Also, how FDCPA relates to all levels of staff. We will also discuss the current regulatory & economic environment to help us determine what 2024 could look like.

Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Justin Muscolino

Understanding the Incredible Uses and Fallbacks of ChatGPT

ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.

Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Justin Muscolino

How Accountants Can Use Chat GPT Effectively

ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.

Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John E Lincoln

3-Hour Virtual Seminar on Quality Management Bootcamp

Whar are the basics of a Quality Management System? This webinar will examine that question by means of the international standard, ISO 9001.

Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
John E Lincoln

Quality Management 101: Enterprise Maintenance Professional's Guide

What are the basics of an enterprise maintenance-focused Quality Management System? This webinar will examine that question by means of the international standard, ISO 9001, the international standard for Quality Management Systems for all business or industrial systems worldwide.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Meredith Crabtree

SOPs - How to Write Them to Satisfy Those Inspectors

Attending this training will help the participant understand the specific requirements and expectations of FDA inspectors, allowing them to develop SOPs that meet regulatory standards and demonstrate compliance.

Speaker: Meredith Crabtree | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Meredith Crabtree

Performance of Root Cause Analysis, CAPA, and Effectiveness Checks

This comprehensive course offers essential knowledge and practical skills in root cause analysis, corrective and preventive actions (CAPA), and conducting effectiveness checks.

Speaker: Meredith Crabtree | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Tom Fragale

ChatGPT for Excel

This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel, like basic navigation and data import/export

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

AI For Excel: Empowering Excel With ChatGPT And Other AI Tools

This course is designed to teach learners how to use CHATGPT and other AI tools for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel, like basic navigation and data import/export

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - A Beginner's Guide to Formulas

Excel is an essential tool for anyone who works with data, from entry-level employees to seasoned professionals. Knowing how to use Excel formulas can help you streamline your work, increase accuracy, and save time.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.

Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Mike Thomas

Excel Basics - Data Visualization - Creating Effective Charts

"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Robert J. Russell

Drug Master Files: Understanding and Meeting Your Regulatory and Processing Responsibilities

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John C. Fetzer

Analytical Method Validation Under Good Laboratory Practices - GLPs

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John C. Fetzer

The Transfer of Validated Methods

This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Justin Muscolino

Artificial Intelligence (AI) and Fraud: Exploring Risks and Opportunities

With AI, we need to understand the risks and opportunities it presents. The risk can be high, but prevention is the key. With every technology, there can be element of good and evil. Within financial services. AI can be applied to identify unusual activity, show inconsistent data, remove manual efforts, improve collaboration, and offer a quick and efficient means to review vast amounts of information.

Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Ray Evans

ChatGPT for Excel Intermediate Masterclass

Harness the awesome power of AI to take Excel to a new level and boost your efficiency working smarter and faster.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

ChatGPT for Excel Essentials Made Easy

Gain easy-to-understand and practical "hands-on" knowledge of ChatGPT and Artificial Intelligence (AI) with a focus on significantly enhancing capabilities in Microsoft Excel.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Outlook Email Calendar & Contacts Essentials Masterclass

Microsoft Outlook is the powerhouse in managing email, appointments, tasks and contacts.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Powerpoint Creating & Presenting a Complete Slide Show

From animations and video, through to organisation charts and process flows, PowerPoint is your complete presentation graphics package providing everything you need for communicating information in an engaging and professional format.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Starting with Excel - the Vital Essentials

This webinar effectively promotes a sound understanding of the Excel interface, features and capabilities incorporating hands-on practice, productivity tips and shortcuts.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Roger Cowan

Pharmaceutical Compressed Air - Quality GMP Standards and Requirements

Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product.

Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John E Lincoln

Device Changes, FDA Changes, and the 510(k)

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Tom Fragale

4-Hour Virtual Seminar on Bootcamp on Excel

In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.

Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Tom Fragale

4-Hour Virtual Seminar on Managing Large Amounts of Data with Excel Charts, Power Query, Pivot Tables, and PowerPivot

In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.

Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Meredith Crabtree

Challenges to Compliance: Understanding Dietary Supplement Oversight by the FDA

“From Challenges to Compliance: Understanding Dietary Supplement Oversight by the FDA” is a comprehensive training session designed to provide participants with an understanding of the role of the Food and Drug Administration (FDA) in regulating dietary supplements.

Speaker: Meredith Crabtree | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Garrett Wasny

Introduction to Generative AI for Accountants

This course offers an in-depth look into Generative AI and its transformative impact on the accounting profession. At the core of Generative AI are technologies that can literally "see, speak, hear, write, and create" in multimodal contexts.

Speaker: Garrett Wasny | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Garrett Wasny

ChatGPT for Innovative Business Advisory Services for Accountants

The course provides a concise overview of how accounting professionals can leverage ChatGPT, OpenAI's powerful language model, to innovate and enhance their business advisory services. In plain language the presentation integrates theory and practice, and demonstrates how various enterprise evaluation methodologies can be applied in combination with ChatGPT to sharpen your business analysis and increase your organization’s efficiency, profitability, and growth

Speaker: Garrett Wasny | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Garrett Wasny

Excel & ChatGPT Synergy Masterclass: Unleashing Financial Analysis Superpowers

In today's data-driven landscape, the fusion of Excel's computational might with ChatGPT's intelligent querying transforms ordinary accounting tasks into dynamic, insightful financial analyses. This specialized masterclass unveils the power behind integrating Excel and ChatGPT, aimed at accountants, financial analysts, and business professionals eager to unlock new levels of efficiency and creativity in their financial workflows.

Speaker: Garrett Wasny | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Garrett Wasny

ChatGPT and Complex Financial and HR Conversations for Accountants

The course provides a concise overview of how accountants can use ChatGPT to assist with communications involving intricate and often sensitive topics that require a deep understanding of both financial principles and human resource policies. These conversations can range from budgeting and compensation to ethical considerations and regulatory compliance.

Speaker: Garrett Wasny | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Audit Trails - Critical to Support FDA 21 CFR Part 11 and Data Integrity Compliance

In particular, industry citations have increased as they relate to areas of Part 11 and data integrity. At the heart of these, is the ability to ensure that no original record is obscured, or is destroyed before the retention period has ended. The best way to preserve database records, those that are uniformly structured, is to place an audit trail on the file. The audit trail will create a new record every time a record is updated, including the old value, new value, date, time, person who authentically performed the modification to the record, and the reason for the change.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - A Beginner's Guide to Formulas

Excel is an essential tool for anyone who works with data, from entry-level employees to seasoned professionals. Knowing how to use Excel formulas can help you streamline your work, increase accuracy, and save time.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Essential Tips and Tricks for the New User

Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.

Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Tom Fragale

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel: Tips and Tricks and Shortcuts

Microsoft Excel has become the de facto spreadsheet application for business.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel Pivot Tables, Pivot Charts, Slicers, and Timelines

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel PowerPivot and Power Query

If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Gary Cokins

The Top 7 Trends in Management Accounting

Ultimately costing principles, such as the causality principle, must be converted into practical practices with supporting tools.

Speaker: Gary Cokins | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Justin Muscolino

Fair Debt Collection Practices Act (FDCPA)

During this webinar, Justin will discuss an overview of the FDCPA, history, provisions, recent updates and how it came about. Also, how FDCPA relates to all levels of staff. We will also discuss the current regulatory & economic environment to help us determine what 2024 could look like.

Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Justin Muscolino

Understanding Artificial Intelligence (AI) and The Incredible Uses and Fallbacks of ChatGPT

ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.

Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Willy Vandenbrande

Beyond ESG Compliance: Quality for a Sustainable Future

As an introduction we point out how important sustainability is for the planet as a whole and how companies will be faced with increasing demands on their impact on society, in all aspects of the term. We also give a brief overview of how sustainability has been wrongly tackled in the past.

Speaker: Willy Vandenbrande | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Dr. Kimberly N. West

Creating Courses with AI

In today's digital world, artificial intelligence (AI) is making waves in education. But with all the talk of AI-powered this and AI-powered that, you might be wondering, "What does that even mean for me as a teacher?"

Speaker: Dr. Kimberly N. West | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dr. Kimberly N. West

AI For Project Managers

AI for Project Managers: Boost Your Skills and Supercharge Your Projects

Speaker: Dr. Kimberly N. West | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dr. Kimberly N. West

AI Policy and Governance in Corporate Environments

Mastering AI Governance: Leading the Way Responsibly

Speaker: Dr. Kimberly N. West | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel Pivot Tables, Pivot Charts, Slicers, and Timelines

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel: Tips and Tricks and Shortcuts

Microsoft Excel has become the de facto spreadsheet application for business.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel Pivot Tables, Pivot Charts, Slicers, and Timelines

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Creating an Interactive Dashboard

No matter what business you are in, a dashboard is a critical tool in your communication armory and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel is commonly used due to its power, its flexibility, and the fact that most people have it installed on their computers.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.

Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Alan Murray

AI for Excel: Empowering Excel with ChatGPT and other AI Tools

In this webinar, we take an in-depth exploration of how AI, particularly ChatGPT, can revolutionize Excel usage and go beyond traditional spreadsheet functionalities. Attendees will gain valuable insights into the following key topics:

Speaker: Alan Murray | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

6-Hour Virtual Seminar on FDA Audit Preparation, Inspection Conduct and Do's and Don'ts

This seminar is broken into two phases. Phase one corresponding to Day 1 will build basic knowledge of the inspection - the who, what, and when. Phase Two will delve into the how of the inspection from the perspectives of the FDA and those being inspected.

Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Charles H. Paul

6-Hour Virtual Seminar on Project Management for Non-Project Managers

What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant. You are half listening to the presentation while thinking about some of the other work you need to complete on different matters. The installation will take a year to execute and will require the coordination with several functions inside and outside of the company.

Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
John C. Fetzer

Dealing with Difficult Customers Effectively

People and communications skills are very important in dealing with customers, but have little connection to doing good lab work. This webinar points out some approaches and skills to connect the two areas.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John C. Fetzer

HPLC Analytical Method Development and Validation

Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John C. Fetzer

Analytical Method Validation Under Good Laboratory Practices - GLPs

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John E Lincoln

The Most Common Problems in FDA Software Validation & Verification

This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management For Non-Project Managers - How To Communicate Project Actions And Progress - Conducting Effective Project Review Meetings

This webinar is about effective communication inside and outside of the project team. The webinar will use case studies and examples to reinforce key teaching points. Instruction will begin with a discussion of the communication model and the barriers that can erect obstacles to understanding the information and intent of the communications sent and received.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - Scheduling your Project

This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project's objectives.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

3-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. The rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.

Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Edwin Waldbusser

Engineering Change Control

This webinar will describe a system, based on the regulations and practical experience that will allow for efficient control of the change process.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 Conformance for Medical Devices

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

How to Prepare for and Host an FDA Inspection and respond to 483's

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Ginette Collazo

How to Write SOP's that Avoid Human Error

This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOPs to reduce the likelihood of human errors.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

6-Hour Virtual Seminar on GCP/GLP/GMP : Comparison and Understanding of the FDA’s 3 Major Regulations

The Good Laboratory Practice regulations describe the minimal standards for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by FDA or EPA such as animal food additives, human and animal drugs, medical devices for human use, biological products, electronic products, or pesticide products.

Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Tom Fragale

4-Hour Virtual Seminar on Bootcamp on Excel

In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.

Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Tom Fragale

4-Hour Virtual Seminar on Managing Large Amounts of Data with Excel Charts, Power Query, Pivot Tables, and PowerPivot

In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.

Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
John E Lincoln

The New US FDA 21 CFR 820, Quality Management System Regulation (QMSR), Medical Device CGMPs

This webinar will discuss what the new QMSR will require. A key element is the incorporation of ISO 13485 into the new 820 by reference. Major emphasis will be upon risk management in accordance with ISO 14971 (-:2019), which currently has only casual reference in 820.30. The FDA views risk management as an “essential systematic practice” to ensure that devices are safe and effective. If the proposed rule is finalized, it will enhance some parts of ISO 13485. Device manufacturers will need to enhance risk management procedures for specific devices and in all other areas of their businesses to align with the QMSR. Design Control (ISO 13485 7.3 Design and Development) will have limited application to Class I devices, but fully involve Class II and III (US classifications) as is currently done in the US but not the EU.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Willy Vandenbrande

Quality 4.0: Managing Disruptive Change

The feeling is sometimes created that technology itself leads the waves of change.

Speaker: Willy Vandenbrande | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Mike Thomas

Power BI Demystified: Transforming Data into Stunning Visuals

Are you ready to embark on a journey that will revolutionize the way you work with data? Welcome to "Power BI Demystified: Transforming Data into Stunning Visuals”

Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Build Advanced Pivot Table Solutions Using the Data Model & PowerPivot

Your data is only as good as the information you can derive from it. Power Pivot enables you to gain better business insights and make more informed business decisions.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Reporting Simplified - Learn Pivot Tables from Scratch

Unlock the power of Excel's data analysis and Business Intelligence (BI) toolkit with Pivot Tables. Whether you're aiming to construct dynamic dashboards, conduct in-depth data analysis, or simply streamline data summaries for personal or business purposes, Pivot Tables are your key to success.

Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Mastering Lookup Functions

"How do I look up a value in list ONE and pick up a related value from list TWO"

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Mastering Logic Functions

Become an Excel Hero in your organization! Make yourself indispensable. If these are your goals, having a good understanding of Excel's Logic functions is critical. It will help you with scenarios like these:

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Master the Latest & Greatest 365-Only Functions

Elevate your Excel prowess with this training. Aimed at users already versed in Excel's core functions (SUM, X/VLOOKUP, COUNTIF etc), this course introduces users to some of the new innovative functions added since 2020, exclusively available to Microsoft 365 and Excel 2021 users

Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - 10 Key Worksheet Functions to Skyrocket Your Productivity

An often-asked question by Excel users is "Which Excel worksheet functions are truly essential?"

Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Larry Stevens

Understanding the Mindset of an FDA Employee

During this webinar we will provide information on the backgrounds of FDA employees, how FDA employees are trained, how they interact with the regulated industry.

Speaker: Larry Stevens | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Ray Evans

ChatGPT for Excel Intermediate Masterclass

Harness the awesome power of AI to take Excel to a new level and boost your efficiency working smarter and faster.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

ChatGPT for Excel Essentials Made Easy

Gain easy-to-understand and practical "hands-on" knowledge of ChatGPT and Artificial Intelligence (AI) with a focus on significantly enhancing capabilities in Microsoft Excel.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Excel Lookup Functions Xlookup & Error Suppression

Going “beyond the basics” Ray Evans clearly demonstrates, features and functionality that enhance the power and flexibility of lookup functions at intermediate level.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Outlook Email Calendar & Contacts Essentials Masterclass

Microsoft Outlook is the powerhouse in managing email, appointments, tasks and contacts.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Project Essentials of Setup Calendars Tasks Scheduling & WBS

Plan and initiate your projects with confidence, knowledge and consistency.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Excel Formulas Functions & Automatic Calculation Made Easy

Understand and work effectively with fundamental and versatile calculation and analysis techniques in Excel.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

PowerPoint Creating & Presenting a Complete Slide Show

From animations and video, through to organisation charts and process flows, PowerPoint is your complete presentation graphics package providing everything you need for communicating information in an engaging and professional format.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Excel Linking Techniques with Word PowerPoint Access & Web

Understand and apply the power of linking techniques within Excel and other key MS Office applications to boost productivity and efficiency for you and your organization.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Excel PivotTable Essentials for Data Management

PivotTables are reputed to be the most powerful “in-built” feature in Excel aside from Macros.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Excel Vital Introductory Essentials with Tips & Shortcuts

This webinar effectively promotes a sound understanding of the Excel interface, features and capabilities incorporating hands-on practice, productivity tips and shortcuts.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Justin Muscolino

How Accountants Can Use Chat GPT Effectively

ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.

Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Justin Muscolino

Understanding the Incredible Uses and Fallbacks of ChatGPT

ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.

Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Meredith Crabtree

SOPs - How to Write Them to Satisfy Those Inspectors

Attending this training will help the participant understand the specific requirements and expectations of FDA inspectors, allowing them to develop SOPs that meet regulatory standards and demonstrate compliance.

Speaker: Meredith Crabtree | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Meredith Crabtree

Performance of Root Cause Analysis, CAPA, and Effectiveness Checks

This comprehensive course offers essential knowledge and practical skills in root cause analysis, corrective and preventive actions (CAPA), and conducting effectiveness checks.

Speaker: Meredith Crabtree | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

China Regulatory Compliance for Life Sciences

China's Life Sciences Compliance webinar will discuss the regulatory structure and requirements for compliance against China's NMPA regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

US, EU, Japan GMP Requirements

This ICH GMP 90-minute webinar will provide your company the opportunity for comprehensive understanding of ICH Drug / Biologic GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan).

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

US Market Access & Reimbursement; Medical Devices

This targeted 60-minute U.S. Reimbursement training/webinar will help you understand and navigate the complex U.S. system for understanding product reimbursement status and potential for your Medical Device.

Speaker: Robert J. Russell | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Beyond Charts: Unleashing Creative Data Visualization

Revolutionize the way you communicate data with this cutting-edge training on Excel visual storytelling. Discover the power of visual data representation to transform complex numerical information into compelling, insightful visual narratives

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - A Beginner’s Guide to Creating Effective Charts

Impress your boss. Impress your colleagues. Turn drab into fab. Tell your story with awesome charts in Excel. This webinar will equip you with the knowledge you need to turn your numerical data into a set of engaging, attention-grabbing and easy-to-understand visuals!

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Power Query - No Code Automation Every User Needs to Know About

Turn bad data into great data in minutes!

Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices

This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

3-Hours Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. The rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.

Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Carolyn Troiano

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and the new FDA Draft Guidance

Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Medical Device Software Validation Meeting FDA Regulations

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

How to Prepare for and Host an FDA Inspection and respond to 483's

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Robert J. Russell

EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

The Human Error Toolbox: A Practical Approach to Human Error

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

How to Write SOPs that Avoid Human Error

Human error is known to be the primary cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mike Thomas

Outlook - Master your Mailbox - Inbox Hero Inbox Zero

For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel PowerPivot and Power Query

If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

4-Hour Virtual Seminar on Bootcamp on Excel

In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.

Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Tom Fragale

Excel Pivot Tables, Pivot Charts, Slicers, and Timelines

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

4-Hour Virtual Seminar on Managing Large Amounts of Data with Excel Charts, Power Query, Pivot Tables, and PowerPivot

In today's world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.

Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Tom Fragale

Excel PowerPivot and Power Query

If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Lists and Tables - A Beginner's Guide to Managing List-Based Data

Often perceived as a mere number-crunching tool, Excel's true prowess lies in its capacity to organize and manage list-based data efficiently and this training session is designed to unveil Excel's full potential beyond arithmetic computations.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - A Beginner's Guide to Formulas

Excel is an essential tool for anyone who works with data, from entry-level employees to seasoned professionals. Knowing how to use Excel formulas can help you streamline your work, increase accuracy, and save time.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Essential Tips and Tricks for the New User

Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Michael Esposito

The Importance of Packaging and Labeling in Pharmaceutical Product Development

Occupying a critical position in the success or failure of any pharmaceutical product launch, Packaging and Labeling form a bridge between the conception of a product and its realization and distribution.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

FDA Best Audit Practices - Do’s And Don’ts

This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management For Non-Project Managers - How To Communicate Project Actions And Progress - Conducting Effective Project Review Meetings

This webinar is about effective communication inside and outside of the project team. The webinar will use case studies and examples to reinforce key teaching points. Instruction will begin with a discussion of the communication model and the barriers that can erect obstacles to understanding the information and intent of the communications sent and received.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - Determining the work that needs to be done

This webinar will walk the participant through the entire process of decomposing a project's tasks into workable schedulable elements called work packages.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - How to effectively monitor and control your project

This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Justin Muscolino

The Importance Of Training Compliance Officers

Since Compliance Officers have direct contact with all parts of the business, it’s essential that they have the necessary tools to succeed and help shift the compliance culture of an organization. This webinar is geared towards Compliance Officers in an organization that deal with internal stakeholders. We will discuss ways to train compliances officers effectively and how to go about it.

Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Justin Muscolino

Enhancing Compliance Officers Capacities

Since Compliance Officers have direct contact with all parts of the business, it’s essential that they have the necessary tools to succeed and help shift the compliance culture of an organization.

Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Justin Muscolino

Conducting A Thorough Needs Analysis And Developing A Solid Compliance Training Program

During this webinar, we go through each step and discuss best practices to create and implement a successful compliance training program

Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Justin Muscolino

Understanding The Incredible Uses And Fallbacks Of ChatGPT

ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.

Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Forrest Breyfogle

Lean Six Sigma and Operational Excellence 2.0

This session describes how to solve costly business problems and add real value to organizations by applying the best of Lean Six Sigma with enhanced score-carding within an Operational Excellence system.

Speaker: Forrest Breyfogle | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Forrest Breyfogle

Metric Reports that Lead to the Best Behaviors (Using a Free App)

Effective Key Performance Indicator (KPI) metric management in an organization is critical; however, there are issues with traditional metric reporting and its accompanying goal-setting practices.

Speaker: Forrest Breyfogle | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Scientific Writing Fundamentals - Mastering the Basics in Life Sciences Documentation

Scientific Writing Fundamentals - Mastering the Basics in Life Sciences Documentation is a dynamic and comprehensive 90-minute webinar designed to empower researchers, students, and professionals in the life sciences field with essential skills for effective written communication.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Writing for Regulatory Success - Strategies for Quality Technical Documents

This 90-minute webinar is designed to provide professionals across various industries with a comprehensive understanding of the critical intersection between effective technical writing, regulatory compliance, and copyright considerations.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Post-Market Surveillance And Project Management Ensuring Long-term Success

This 90-minute webinar delves into the critical intersection of post-market surveillance and project management, providing professionals across industries with comprehensive insights into ensuring long-term success.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Arvilla Trag

SOPs for Virtual Companies - What You Need and What You Don't

Many virtual companies incorrectly think they don't need SOPs or GMP training.

Speaker: Arvilla Trag | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Susanne Manz

Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices

This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Secrets to Writing Effective SOPs for Medical Device QMS

Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

GAMP5, Second Edition and Alignment with Computer Software Assurance (CSA) and Digital Validation

We will explore the latest best industry practices offered in GAMP®5 (Second Edition) and understand what it offers to those validation computer systems in the FDA-regulated industries. We will cover the changes and impact on validation as a result. We will also cover FDA’s recent draft guidance on Computer Software Assurance (CSA) and what that means in terms of how to approach validation.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Medical Device Cybersecurity - FDA Guidance for Quality System Considerations and Content of Premarket Submissions

This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could result in injury or death to a patient or consumer. A serious threat, it must be dealt with at all levels to make sure the end product being used by a patient or consumer is perfectly safe and delivers the effective treatment required

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Vendor Audit - Focus on Cloud, Software-as-a-Service (SaaS), and Other Technologies used for FDA-Regulated Activities

We will discuss the importance of applying industry best practices when auditing a vendor of hardware, software, or other technology, or a provider of technology services, such as system implementation, system configuration, system development, system integration or similar activity

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Validation of Artificial Intelligence (AI), Machine Language (ML), and other Superintelligence-Based Systems Regulated by FDA

During the webinar, we will discuss FDA’s considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways difficult to foresee. You’ll also learn about current and potential uses of AI in health care and the challenges posed. We’ll cover how and under what circumstances products relying on AI are regulated by FDA, and how to ensure benefits of products outweigh risks.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Audit Trails - Critical to Support FDA 21 CFR Part 11 and Data Integrity Compliance

In particular, industry citations have increased as they relate to areas of Part 11 and data integrity. At the heart of these, is the ability to ensure that no original record is obscured, or is destroyed before the retention period has ended. The best way to preserve database records, those that are uniformly structured, is to place an audit trail on the file. The audit trail will create a new record every time a record is updated, including the old value, new value, date, time, person who authentically performed the modification to the record, and the reason for the change.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Pharma 4.0 Focus - Newer Approaches and Technologies to Reduce Costs while Complying with FDA's 21 CFR Part 11, Data Integrity

FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries. These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA. All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, images, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Macros In Excel - Automated Productivity & Time Savings

To gain a practical “hands-on” understanding of how to efficiently create, manage and run Macros in Excel.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Using Excel PivotTables to Easily Summarize and Analyze Data

The ability to analyze data is a powerful skill that helps make better decisions. Microsoft Excel is one of the top tools for data analysis and PivotTables are arguably the most popular analytic tool.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Starting with Excel - The Vital Essentials

This webinar effectively promotes a sound understanding of the Excel interface, features and capabilities incorporating hands-on practice, productivity tips and shortcuts

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Making your Excel Spreadsheet much Easier to use with Tables

Tables are a powerful Excel functionality to streamline many data management functions.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Pivot Table Essentials for Data Analytics in Excel

A PivotTable displays a summary of a selected data set in a condensed format of rows, columns, data fields, and pages. These components can be "pivoted" with your mouse allowing you to expand, isolate, calculate, and group the particular data in real time. This table empowers the user to view and analyze large amounts of information.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Excel - Mastering Lookup Functions

"How do I look up a value in list ONE and pick up a related value from list TWO"

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Project Management - Tasks Work Breakdown Structure Linking & Scheduling in MS Project

Understanding effective and accurate task management, durations, linking and scheduling are essential to start your projects correctly and minimise major adjustments, delays and cost impacts.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Human Error Reduction Techniques for Floor Supervisors

Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

How to Write SOPs that Avoid Human Error

Human error is known to be the primary cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and the new FDA Draft Guidance

Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Medical Device Software Validation Meeting FDA Regulations

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

How to Prepare for and Host an FDA Inspection and respond to 483's

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John C. Fetzer

Analytical Method Validation Under Good Laboratory Practices - GLPs

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John C. Fetzer

The Transfer of Validated Methods

This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John E Lincoln

3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements

Verification and validation requirements have always been part of the US FDA's GMPs. Yet companies still struggle with the performance of and documentation of Equipment, Process, Software, and quality management system validations.

Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
John E Lincoln

Device Changes, FDA Changes, and the 510(k)

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".

Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel Basics - Data Visualization - Creating Effective Charts

"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.

Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Mike Thomas

Excel - Quick Tips to Help You be More Productive

Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Mastering Lookup Functions

"How do I look up a value in list ONE and pick up a related value from list TWO"

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Justin Muscolino

How accountants can use Chat GPT Effectively

ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.

Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Ginette Collazo

Human Error Reduction Techniques for Floor Supervisors

Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

How to Write SOPs that Avoid Human Error

Human error is known to be the primary cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Larry Stevens

Effective (and FDA Accepted Responses) to FDA 483s and Warning Letters

If you work for any firm that manufactures products regulated by FDA, you very likely will experience an FDA inspection.

Speaker: Larry Stevens | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Justin Muscolino

Understanding the incredible uses and fallbacks of ChatGPT

ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.

Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Medical Device Software Validation Meeting FDA Regulations

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

How to Prepare for and Host an FDA Inspection and Respond to 483's

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mike Thomas

Outlook - Master your Mailbox - Inbox Hero Inbox Zero

For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel Basics - Data Visualization - Creating Effective Charts

"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Mastering Lookup Functions

"How do I look up a value in list ONE and pick up a related value from list TWO"

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Carolyn Troiano

3-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

3-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Carolyn Troiano

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

The Most Common Problems in FDA Software Validation & Verification

This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Device Changes, FDA Changes, and the 510(k)

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".

Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Willy Vandenbrande

Beyond ESG: Quality for a Sustainable Future

As an introduction we point out how important sustainability is for the planet as a whole and how companies will be faced with increasing demands on their impact on society, in all aspects of the term.

Speaker: Willy Vandenbrande | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

How to Write SOPs for Human Error Reduction

Human error is known to be the primary cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

The Human Error Toolbox: A Practical Approach to Human Error

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Human Error Reduction Techniques for Floor Supervisors

Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

How to Write SOPs that Avoid Human Error

Human error is known to be the primary cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Medical Device CyberSecurity Following the September 2023 FDA Premarket Guidance

This webinar will explain the process of analyzing and minimizing cyber risks for premarket submissions. It will explain how cyber risks are identified and mitigated.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mike Thomas

Outlook - Master your Mailbox - Inbox Hero Inbox Zero

For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Excel Charts and Graphs

This live webinar will show you quick ways to create charts, explore which chart types work best for different data, and give you tips on when and how to add gridlines, change background colors, adjust scaling, insert titles, re-configure 3-D charts, insert clip art images and add trend lines. You can add both functionality and eye-appeal to your charts with simple formatting techniques.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Mastering Excel Pivot Tables

Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

2-Hour Virtual Seminar on Mastering Excel Pivot Tables

Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.

Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
John E Lincoln

The Most Common Problems in FDA Software Validation & Verification

This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel PowerPivot and Power Query

If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

4-Hour Virtual Seminar on Bootcamp on Excel

In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.

Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Tom Fragale

Excel Pivot Tables, Pivot Charts, Slicers, and Timelines

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel: Tips and Tricks and Shortcuts

Microsoft Excel has become the de facto spreadsheet application for business.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

4-Hour Virtual Seminar on Managing Large Amounts of Data with Excel Charts, Power Query, Pivot Tables, and PowerPivot

In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.

Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Tom Fragale

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Michael Esposito

3-Hour Virtual Seminar on SOP Writing, Training, and Compliance in the Pharmaceutical Industry

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.

Speaker: Michael Esposito | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Michael Esposito

Good Manufacturing Practices (GMP) - An Introduction

Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Michael Esposito

Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success

The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John C. Fetzer

The Transfer of Validated Methods

This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Medical Device Software Validation Meeting FDA Regulations

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

How to Prepare for and Host an FDA Inspection and respond to 483's

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Carolyn Troiano

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software

Advancements in technology have forced organizations to rethink business models.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Project Management - Tasks Work Breakdown Structure Linking & Scheduling in MS Project

Understanding effective and accurate task management, durations, linking and scheduling are essential to start your projects correctly and minimise major adjustments, delays and cost impacts.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Starting with Excel - The Vital Essentials

This webinar effectively promotes a sound understanding of the Excel interface, features and capabilities incorporating hands-on practice, productivity tips and shortcuts

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Using Excel PivotTables to Easily Summarize and Analyze Data

The ability to analyze data is a powerful skill that helps make better decisions. Microsoft Excel is one of the top tools for data analysis and PivotTables are arguably the most popular analytic tool.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Create and Present a Complete Slideshow in MS PowerPoint

Engaging and professional new features help you dazzle your audience with a wide range of captivating options.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences

This seminar will begin with a general discussion of technical writing and its role within the life sciences.

Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Susanne Manz

Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices

This webinar will help you understand the critical ingredients for conducting an effective root cause analysis.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Secrets to Writing Effective SOPs for Medical Device QMS

Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dennis Taylor

Excel Data Management Tools

Microsoft says that up to 70% of users surveyed use Excel to maintain a database or large lists. To be truly proficient in Excel, you must be familiar with these tools to manage data efficiently.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Excel Formulas and Functions

Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

2-Hour Virtual Seminar on Mastering Excel Pivot Tables

Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.

Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Ginette Collazo

How to Write SOPs for Human Error Reduction

Human error is known to be the primary cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

How to Write SOPs that Avoid Human Error

Human error is known to be the primary cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Current Trends in FDA Compliance and Enforcement for Regulated Computer Systems and Data

Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to the FDA.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software

Advancements in technology have forced organizations to rethink business models.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and the new FDA Draft Guidance

Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

How to Prepare for and host an FDA Inspection and respond to 483's

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Michael Esposito

Good Manufacturing Practices (GMP) - An Introduction

Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug products in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Michael Esposito

Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success

The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training, and experience to complete their job functions.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mike Thomas

Outlook - Master your Mailbox - Inbox Hero Inbox Zero

For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel Basics - Data Visualization - Creating Effective Charts

"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.

Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Mike Thomas

Excel - Quick Tips to Help You be More Productive

Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Mastering Lookup Functions

"How do I look up a value in list ONE and pick up a related value from list TWO"

Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Business Continuity Planning For Contract Manufacturers In The Life Sciences

Business continuity planning is crucial for contract manufacturers operating in the life sciences industry

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

2-Hour Virtual Seminar on Reduce Performance Failures in Your Operations by Addressing Human Performance, Human Error, and Cognitive Effort

In today's fast-paced operational environments, organizations face challenges related to human performance, human error, and mental load. This comprehensive two-hour training program aims to equip participants with the knowledge, skills, and strategies to reduce performance failures in operations.

Speaker: Charles H. Paul | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Michael Esposito

3-Hour Virtual Seminar on SOP Writing, Training, and Compliance in the Pharmaceutical Industry

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.

Speaker: Michael Esposito | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Michael Esposito

Good Manufacturing Practices (GMP) - An Introduction

Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug products in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Roger Cowan

CMO Supplier Quality Agreements - What you need to know to comply with new FDA & EU GMP Guidelines for Contract Drug Manufacture

A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety, and efficacy of the manufactured drug.

Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Susanne Manz

Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices

This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Making your Excel Spreadsheet much Easier to use with Tables

Tables are a powerful Excel functionality to streamline many data management functions.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Preventing Human Error in the Life Sciences

This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - How to Communicate Project Actions and Progress - Conducting Effective Project Review Meetings

This webinar is about effective communication inside and outside of the project team.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - Determining the Work that needs to be done

This webinar will walk the participant through the entire process of decomposing a project’s tasks into workable schedulable elements called work packages.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - How to Effectively Monitor and Control your Project

This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

How to Write SOPs that Avoid Human Error

Human error is known to be the primary cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Tom Fragale

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel PowerPivot and Power Query

If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

4-Hour Virtual Seminar on Managing Large Amounts of Data with Excel Charts, Power Query, Pivot Tables, and PowerPivot

In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.

Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Tom Fragale

Excel: Tips and Tricks and Shortcuts

Microsoft Excel has become the de facto spreadsheet application for business.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel Pivot Tables, Pivot Charts, Slicers, and Timelines

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Outlook - Master your Mailbox - Inbox Hero Inbox Zero

For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel Basics - Data Visualization - Creating Effective Charts

"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.

Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Dennis Taylor

Excel Charts and Graphs

This live webinar will show you quick ways to create charts, explore which chart types work best for different data, and give you tips on when and how to add gridlines, change background colors, adjust scaling, insert titles, re-configure 3-D charts, insert clip art images and add trend lines. You can add both functionality and eye-appeal to your charts with simple formatting techniques.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Excel Data Management Tools

Microsoft says that up to 70% of users surveyed use Excel to maintain a database or large lists. To be truly proficient in Excel, you must be familiar with these tools to manage data efficiently.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Mastering Excel Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Robert J. Russell

EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

How to Prepare for and host an FDA Inspection and respond to 483's

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Ginette Collazo

How to Write SOP's for Human Error Reduction

Human error is known to be the primary cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

The Human Error Toolbox: A Practical Approach to Human Error

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Human Error Reduction Techniques for Floor Supervisors

Human Error Reduction Techniques for Floor Supervisors

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

How to Write SOP's that Avoid Human Error

Human error is known to be the primary cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn about what processes need to be validated and what steps you need to take to validate processes.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Susanne Manz

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

How to Comply with FDA and European Regulatory Guidelines for Contract Manufacturing Operations - The CMO Supplier Agreement

The webinar begins with an introduction to the regulatory landscape governing contract manufacturing operations. The presenter, an industry expert with extensive knowledge of FDA and European regulatory guidelines, sets the stage by highlighting the importance of compliance and its impact on product quality, patient safety, and market access.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - Scheduling your Project

This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project’s objectives.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Excel Charts and Graphs

This live webinar will show you quick ways to create charts, explore which chart types work best for different data, and give you tips on when and how to add gridlines, change background colors, adjust scaling, insert titles, re-configure 3-D charts, insert clip art images and add trend lines. You can add both functionality and eye-appeal to your charts with simple formatting techniques.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Mastering Excel Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Excel Formulas and Functions

Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

2-Hour Virtual Seminar on Mastering Excel Pivot Tables

Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.

Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Ray Evans

Pivot Table Essentials for Data Analytics in Excel

A PivotTable displays a summary of a selected data set in a condensed format of rows, columns, data fields, and pages. These components can be "pivoted" with your mouse allowing you to expand, isolate, calculate, and group the particular data in real time. This table empowers the user to view and analyze large amounts of information.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This 3-Hour seminar covers the details of the Regulatory Requirements for a wide range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices, and Combination Products.

Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, and Combination Products in Japan.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John C. Fetzer

The Transfer of Validated Methods

This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Carolyn Troiano

6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.

Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Edwin Waldbusser

Human Factors/ Usability Studies following ISO62366, the FDA Guidance and the new FDA Draft Guidance

Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidance.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

How to Prepare for and host an FDA Inspection and respond to 483's

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

4-Hour Virtual Seminar on Bootcamp on Excel

In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.

Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Tom Fragale

Excel Pivot Tables, Pivot Charts, Slicers, and Timelines

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel: Tips and Tricks and Shortcuts

Microsoft Excel has become the de facto spreadsheet application for business.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Outlook - Master your Mailbox - Inbox Hero Inbox Zero

For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments and to-dos.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.

Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Mike Thomas

Excel - Quick Tips to Help You be More Productive

Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Carolyn Troiano

3-Hours Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.

Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Carolyn Troiano

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Tom Fragale

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy-to-use flexible summary reports using Pivot Tables and Charts. We will start with the basics and build up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

4-Hour Virtual Seminar on Managing Large Amounts of Data with Excel Charts, Power Query, Pivot Tables, and PowerPivot

In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.

Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Tom Fragale

4-Hour Virtual Seminar on Bootcamp on Excel

In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.

Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Susanne Manz

4-Hour Virtual Seminar on Improving Your CAPA Program - And preparing for upcoming changes to the Quality System Regulation

The FDA has spent years updating the Quality System Regulation (QSR 21 CFR, Part 820) and has finally published draft regulation on February 22, 2022 to harmonize the QSR with ISO 13485:2016. If you’re thinking of improvements to your CAPA process, this is the right time to incorporate ISO13485. This seminar will help you prepare for upcoming changes to the QSR and improve your CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Susanne Manz

4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Susanne Manz

6-Hour Virtual Seminar on Audit like the FDA

This 6-hour virtual seminar is an essential guide on how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to self-identify areas of non-compliance.

Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Robert J. Russell

6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations

This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).

Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Susanne Manz

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John C. Fetzer

HPLC Analytical Method Development and Validation

Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Excel Charts and Graphs

This live webinar will show you quick ways to create charts, explore which chart types work best for different data, and give you tips on when and how to add gridlines, change background colors, adjust scaling, insert titles, re-configure 3-D charts, insert clip art images and add trend lines. You can add both functionality and eye-appeal to your charts with simple formatting techniques.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Excel Data Management Tools

Microsoft says that up to 70% of users surveyed use Excel to maintain a database or large lists. To be truly proficient in Excel, you must be familiar with these tools to manage data efficiently.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Mastering Excel Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Excel Formulas and Functions

Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

2-Hour Virtual Seminar on Mastering Excel Pivot Table

Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.

Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Ginette Collazo

How to Write SOP's for Human Error Reduction

Human error is known to be the primary cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

The Human Error Toolbox: A Practical Approach to Human Error

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

How to Write SOP's that Avoid Human Error

Human error is known to be the primary cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

3-Hours Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.

Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Carolyn Troiano

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - Project Management as applied to Clinical Trials

Clinical trial project management is a complex and dynamic process that requires careful planning, coordination, and communication among stakeholders.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - Role of Project Management in Quality Planning throughout the Medical Device Project Lifecycle

Project management plays a critical role in ensuring quality planning and management throughout the product lifecycle. The project manager is responsible for creating a comprehensive quality management plan, implementing quality control procedures, and identifying areas for continuous improvement. By doing so, they ensure that the final product meets the quality objectives and customer requirements.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - How to Communicate Project Actions and Progress - Conducting Effective Project review Meetings

This webinar is about effective communication inside and outside of the project team.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, and Combination Products in Japan.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Mastering Lookup Functions

"How do I look up a value in list ONE and pick up a related value from list TWO"

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Excel Lookup Functions

Excel’s 500+ functions represent a potent set of power tools that simplifies many different kinds of formulas and gives you a huge number of computational possibilities.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Time-Saving Excel Tips, Tricks and 100 Shortcuts

Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Charles H. Paul

Risk Assessment tools and Techniques in the Medical Device Industry - Understanding ISO 14971

Medical Devices by their very nature must be safe for human use and must meet the requirements for which they have been designed. The process which identifies the risks associated with a medical device that could make the device unsafe or not function as intended is called Risk/Hazard Analysis.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dev Strischek

Credit Risk Management - Principles and Practices, Tools and Techniques

Credit Risk Management is the function that ensures the organization is balancing its risk appetite with its risk tolerance to attain the organization’s desired credit risk objectives. This course provides guidance on how to implement and maintain the desired level of credit risk management with practical tools and techniques.

Speaker: Dev Strischek | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dev Strischek

Cash Flow Analysis Of Borrower’s Repayment Ability

There is an old saying in credit analysis, "Borrowers pay back loans from cash flow, not profits." But it is not just cash flow; it is cash flow from operations that is the most desirable source of repayment because it is generated by a borrower managing its working capital assets and earning a sustainable profit.

Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Karl Nobert

2 Hours Virtual Seminar on An Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (''HCT/Ps'') including Stem Cell-Based Drug Products for Human Use

This webinar will review FDA's regulatory oversight of stem cell-based products when used in humans and analyze its potential impact on the industry in the future. Learn FDA's criteria for marketing and promotion of stem cell-based products for therapeutic application.

Speaker: Karl Nobert | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Susanne Manz

6-Hour Virtual Seminar on Audit like the FDA

This 6-hour virtual seminar is an essential guide on how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to self-identify areas of non-compliance.

Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Michael Esposito

Good Manufacturing Practices (GMP) - An Introduction

Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug products in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Michael Esposito

Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success

The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training, and experience to complete their job functions.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - Project Management in the Biomedical Industry

It is not possible to present a complete treatment of project management for this industry in the span of 90 minutes. It is however possible to focus on those most critical project management aspects that are critical to the success of any project within biotechnology and the biomedical industry in general.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers

This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - How to Communicate Project Actions and Progress - Conducting Effective Project review Meetings

This webinar is about effective communication inside and outside of the project team.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Charles H. Paul

FDA Audit Best Practices - Do's and Don'ts

This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Ginette Collazo

Training Effectiveness: How to Develop Instruments to Measure Learning and Reduce Errors

Training programs have evolved through time. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths. Even though Training is considered the "vaccine for mistakes," Training is as good as its effectiveness.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

How to Write SOP's for Human Error Reduction

Human error is known to be the primary cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Supervising a Human Error Free Environment: You can do a Lot More than you Think

Human error is known to be the major cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

6-Hour Virtual Seminar on Project Management for Non-Project Managers

This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
John E Lincoln

4-Hour Virtual Seminar on Combination Product Device Supplier Management Training

There has been a major shift in the emphasis of U.S. FDA requirements for supplier CGMP compliance.

Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
John E Lincoln

6-Hour Virtual Seminar on Inspection and Audit Readiness Training for Medical Device Manufacturers

There has been a major shift in the emphasis of U.S. FDA CGMP compliance audits over the past few years.

Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
John E Lincoln

4-Hour Virtual Seminar on Cybersecurity and US FDA Requirements

Due to the growth of the cybersecurity threat to electronic records, computer-controlled manufacturing, and medical devices, the US FDA has issued Guidances for Industry, e.g.: 1) "Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software Document", and 2) "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", and 3) "Postmarket Management of Cybersecurity in Medical Devices" Draft.

Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn about what processes need to be validated and what steps you need to take to validate processes.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Susanne Manz

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidance.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

How to Prepare for and host an FDA Inspection and respond to 483's

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John C. Fetzer

Validation of HPLC/UPLC Methodologies

This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel Basics - Data Visualization - Creating Effective Charts

"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Creating an Interactive Dashboard

No matter what business you are in, a dashboard is a critical tool in your communication armory and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel is commonly used due to its power, its flexibility, and the fact that most people have it installed on their computers.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Power Query for the Everyday Excel User - Part 1

Turn bad data into great data in minutes!

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.

Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Carolyn Troiano

2-Day Virtual Seminar on Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA

In addition to producing a Trial Master File (TMF), companies engaged in the conduct of human clinical trials must adhere to FDA’s requirements for Computer System Validation (CSV) and Data Integrity. In addition, they must adhere to specific government regulatory requirements. Certain documents, content, and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF).

Speaker: Carolyn Troiano | View Anytime | Duration: 2 Days | Price: $1,045.00 | View Details
Tom Fragale

4-Hour Virtual Seminar on Bootcamp on Excel

In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.

Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Tom Fragale

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy-to-use flexible summary reports using Pivot Tables and Charts. We will start with the basics and build up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel PowerPivot and Power Query

If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel Pivot Tables, Pivot Charts, Slicers, and Timelines

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy-to-use flexible summary reports using Pivot Tables and Charts. We will start with the basics and build up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel: Tips and Tricks and Shortcuts

Microsoft Excel has become the de facto spreadsheet application for business.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Roger Cowan

HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity, and personnel is crucial to protect the product from contamination.

Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Dennis Taylor

Excel Charts and Graphs

This live webinar will show you quick ways to create charts, explore which chart types work best for different data, and give you tips on when and how to add gridlines, change background colors, adjust scaling, insert titles, re-configure 3-D charts, insert clip art images and add trend lines. You can add both functionality and eye appeal to your charts with simple formatting techniques.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Excel Data Management Tools

Microsoft says that up to 70% of users surveyed use Excel to maintain a database or large lists. To be truly proficient in Excel, you must be familiar with these tools to manage data efficiently.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Excel Lookup Functions

Excel’s 500+ functions represent a potent set of power tools that simplifies many different kinds of formulas and give you a huge number of computational possibilities.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Carolyn Troiano

6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.

Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
John E Lincoln

4-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future

One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.

Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Charles H. Paul

6-Hour Virtual Seminar on Project Management for Non-Project Managers

This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Michael Esposito

Good Manufacturing Practices (GMP) - An Introduction

Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug products in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

How to Write SOP's for Human Error Reduction

Human error is known to be the primary cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

How to Write SOP's that Avoid Human Error

This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOPs to reduce the likelihood of human errors.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices

This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn about what processes need to be validated and what steps you need to take to validate processes.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Device Changes, FDA Changes, and the 510(k)

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.

Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Ray Evans

Excel - Mastering Lookup Functions

"How do I look up a value in list ONE and pick up a related value from list TWO"

Speaker: Ray Evans | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Medical Device Software Validation Meeting FDA Regulations

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - How to Communicate Project Actions and Progress - Conducting Effective Project review Meetings

This webinar is about effective communication inside and outside of the project team.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software

Advancements in technology have forced organizations to rethink business models.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Current Trends in FDA Compliance and Enforcement for Regulated Computer Systems and Data

Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to the FDA.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

3-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.

Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Carolyn Troiano

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mike Thomas

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.

Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Mike Thomas

Outlook - Master your Mailbox - Inbox Hero Inbox Zero

For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel Basics - Data Visualization - Creating Effective Charts

"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Mastering Excel Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Excel Formulas and Functions

Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Time-Saving Excel Tips, Tricks and 100 Shortcuts

Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel Pivot Tables, Pivot Charts, Slicers, and Timelines

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy-to-use flexible summary reports using Pivot Tables and Charts. We will start with the basics and build up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy-to-use flexible summary reports using Pivot Tables and Charts. We will start with the basics and build up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

4-Hour Virtual Seminar on Managing Large Amounts of Data with Excel Charts, Power Query, Pivot Tables, and PowerPivot

In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.

Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Tom Fragale

Excel: Tips and Tricks and Shortcuts

Microsoft Excel has become the de facto spreadsheet application for business.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel PowerPivot and Power Query

If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

4-Hour Virtual Seminar on Bootcamp on Excel

In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.

Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Tom Fragale

Excel Pivot Tables, Pivot Charts, Slicers, and Timelines

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy-to-use flexible summary reports using Pivot Tables and Charts. We will start with the basics and build up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel: Tips and Tricks and Shortcuts

Microsoft Excel has become the de facto spreadsheet application for business.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy-to-use flexible summary reports using Pivot Tables and Charts. We will start with the basics and build up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - Project Management as applied to Clinical Trials

Clinical trial project management is a complex and dynamic process that requires careful planning, coordination, and communication among stakeholders.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - Role of Project Management in Quality Planning throughout the Medical Device Project Lifecycle

Project management plays a critical role in ensuring quality planning and management throughout the product lifecycle. The project manager is responsible for creating a comprehensive quality management plan, implementing quality control procedures, and identifying areas for continuous improvement. By doing so, they ensure that the final product meets the quality objectives and customer requirements.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - The Project Management process in the development of In Vitro Diagnostics

Effective project management is essential in the development of In Vitro diagnostics. It ensures the timely completion of the project, and the efficient use of resources, coordination of teams, risk management, and quality management.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - Project Management in Drug Development

It is important for a project manager to understand how the project management process integrates into drug development because drug development is a complex and highly regulated process that involves various stages, including discovery, pre-clinical development, clinical development, regulatory submission, and post-marketing surveillance.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Excel - Mastering Lookup Functions

"How do I look up a value in list ONE and pick up a related value from list TWO"

Speaker: Ray Evans | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Casper Uldriks

6-Hour Virtual Seminar on FDA Scrutiny of Promotion and Advertising Practices

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.

Speaker: Casper Uldriks | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Charles H. Paul

6-Hour Virtual Seminar on Project Management for Non-Project Managers

This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Charles H. Paul

6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences

This seminar will begin with a general discussion of technical writing and its role within the life sciences.

Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Carolyn Troiano

4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.

Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Ginette Collazo

How to Write SOP's for Human Error Reduction

Human error is known to be the primary cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Human Factors/ Usability Studies following ISO62366, the FDA Guidance and the new FDA Draft Guidance

Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, and Combination Products in Japan.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Death by CAPA - Does your Company have the Symptoms?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Quick Tips to Help You be More Productive

Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"

Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Mastering Lookup Functions

"How do I look up a value in list ONE and pick up a related value from list TWO"

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Creating an Interactive Dashboard

No matter what business you are in, a dashboard is a critical tool in your communication armory and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel is commonly used due to its power, its flexibility, and the fact that most people have it installed on their computers.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Power Query for the Everyday Excel User - Part 1

Turn bad data into great data in minutes!

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - 10 Must-Know Functions to Boost Your Productivity

Microsoft Excel contains almost 500 built-in worksheet functions. Strip away the ones nobody uses. Discount the ones that have a specialized use case and you're left with a small set of functions that all Excel users should know, regardless of their job function, industry, or business sector. This webinar covers ten of Excel’s most popular productivity-boosting functions.

Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Roger Cowan

HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity, and personnel is crucial to protect the product from contamination.

Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Tom Fragale

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy-to-use flexible summary reports using Pivot Tables and Charts. We will start with the basics and build up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Ginette Collazo

Training Effectiveness: How to Develop Instruments to Measure Learning and Reduce Errors

Training programs have evolved through time. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths. Even though Training is considered the "vaccine for mistakes," Training is as good as its effectiveness.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - How to Effectively Monitor and Control your Project

This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

FDA Audit Best Practices - Do's and Don'ts

This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John E Lincoln

Project Management for FDA-Regulated Companies

This webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time.

Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John E Lincoln

Failure Investigation and Root Cause Analysis

Closed-loop CAPA mandates a repeatable, systematic Failure Investigation and Root Cause Analysis.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - Scheduling your Project

This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project’s objectives.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - How to Communicate Project Actions and Progress - Conducting Effective Project review Meetings

This webinar is about effective communication inside and outside of the project team.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Michael Esposito

3-Hour Virtual Seminar: SOP Writing, Training and Compliance in the Pharmaceutical Industry

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.

Speaker: Michael Esposito | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices

This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn about what processes need to be validated and what steps you need to take to validate processes.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Roger Cowan

HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity, and personnel is crucial to protect the product from contamination.

Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Casper Uldriks

Responsibility for Off-Label Claims in Social Media

FDA's sweeping definition of labeling includes what is said or represented, even by images, on a social media platform.

Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.

Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Mike Thomas

Outlook - Master your Mailbox - Inbox Hero Inbox Zero

For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel Basics - Data Visualization - Creating Effective Charts

"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Ginette Collazo

How to Write SOP's that Avoid Human Error

This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOPs to reduce the likelihood of human errors.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Human Error Reduction Techniques for Floor Supervisors

Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John C. Fetzer

The Transfer of Validated Methods

This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Medical Device Software Validation Meeting FDA Regulations

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

How to Prepare for and Host an FDA Inspection and Respond to 483's

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Human Factors/ Usability Studies following ISO62366 and the new FDA Guidance

Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel PowerPivot and Power Query

If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel: Tips and Tricks and Shortcuts

Microsoft Excel has become the de facto spreadsheet application for business.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software

Advancements in technology have forced organizations to rethink business models.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Current Trends in FDA Compliance and Enforcement for Regulated Computer Systems and Data

Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to the FDA.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

How to Write SOP's that Avoid Human Error

This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOPs to reduce the likelihood of human errors.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Supervising a Human Error Free Environment: You can do a Lot More than you Think

Human error is known to be the major cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Creating an Interactive Dashboard

No matter what business you are in, a dashboard is a critical tool in your communication armory and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel is commonly used due to its power, it's flexibility, and the fact that most people have it installed on their computers.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Karl Nobert

The U.S. Food and Drug Administration's Regulation of Pet Food: Complying with FDA's Rules for the Marketing and Sale of Dog and Cat Food

This webinar is intended for Pet Food Industry Representatives, Manufacturers, Regulatory Affairs Professionals, Managers, Consultants, Scientists, Research Analysts, Market Watchers, and Investment Analysts seeking an understanding of how pet food is regulated in the United States.

Speaker: Karl Nobert | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Tom Fragale

6-Hour Virtual Seminar on Bootcamp on Excel

In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.

Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Tom Fragale

Excel Pivot Tables, Pivot Charts, Slicers, and Timelines

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

4-Hour Virtual Seminar on Bootcamp on Excel

In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.

Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Tom Fragale

Excel: Tips and Tricks and Shortcuts

Microsoft Excel has become the de facto spreadsheet application for business.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Gwendolyn Wise-Blackman

Validation Challenges for Bioassays

Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support. Unlike analytical test methods for small molecules, bioassays have unique requirements due to the variable nature of some critical components.

Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Gwendolyn Wise-Blackman

Implementing Process Controls for Cell-Based Assays

Bioassays are used to demonstrate that a biological product performs per the stated function and potency. Typically, these methods are performed in living systems. Cell-based methods can have inherent variability due to the nature of living systems. Minimizing potential variability can be achieved through careful documentation and analysis of assay performance on control charts.

Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Charles H. Paul

6-Hour Virtual Seminar on Project Management for Non-Project Managers

This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Carolyn Troiano

4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.

Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Carolyn Troiano

6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.

Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Dennis Taylor

Mastering Excel Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Excel Formulas and Functions

Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Time-Saving Excel Tips, Tricks and 100 Shortcuts

Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

2-Hour Virtual Seminar on Mastering Excel Pivot Tables

Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.

Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Michael Esposito

Good Manufacturing Practices (GMP) - An Introduction

Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Michael Esposito

Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success

The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Making your Excel Spreadsheet much Easier to use with Tables

Tables are a powerful Excel functionality to streamline many data management functions.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Mastering Data And Information Management Essentials

Skills to effectively manage, present and communicate data are now vital in the competitive financial and business analysis fields and offer vast opportunities to expand accounting client services and career paths.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations

This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).

Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Tom Fragale

4-Hour Virtual Seminar on Managing Large Amounts of Data with Excel Charts, Power Query, Pivot Tables, and PowerPivot

In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.

Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Carolyn Troiano

4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.

Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Carolyn Troiano

6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.

Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Dev Strischek

Part 2- How to Write More Effective Emails - Improving Your E-Communication Skills

Emails are a core business communication tool. The speed and volume of email have dramatically changed business communication. The not-so-old standards for professional correspondence have changed and will continue to do so. Employees need to know the best strategies to communicate effectively. An effective business email is easily understood, but it is not so easily written.

Speaker: Dev Strischek | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dev Strischek

Part 1- How to Write Right for Better Business Communication

Good leaders walk the talk, but they also “write right”. They know how to say in a few words what needs to be said in crisp, clear language. The road to bad communication is paved with good intentions but poor construction. Readers know when subjects and verbs don’t agree when punctuation misses the point when words don’t fit, and content is confusing. In this session, learn how a few basic rules on grammar, punctuation, and usage can improve business written communications with clearer, more succinct content.

Speaker: Dev Strischek | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dev Strischek

C for Yourself: The 5 C’s of Credit

The first four C's-capacity, conditions, collateral, and character- evaluate a borrower's ability to repay, but character forces the lender to examine closely the borrower's willingness to repay.

Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Charles H. Paul

FDA Audit Best Practices - Do's and Don'ts

This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Charles H. Paul

Preventing Human Error in the Life Sciences

This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers

This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - Scheduling your Project

This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project’s objectives.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - Determining the Work that needs to be done

This webinar will walk the participant through the entire process of decomposing a project’s tasks into workable schedulable elements called work packages.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - How to Effectively Monitor and Control your Project

This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Reconciling/Adapting the 8D Problem Solving Process with ISO regulations and 21CFR 820

This webinar will begin with an explanation of the process and how it originally conflicted with all regulatory bodies worldwide and how it now can be applied, with minor adjustments, to counter those original difficulties. The webinar will also discuss when the process should be used, how it should be staffed, and the process for its use.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Computer System Validation (CSV) and Computer Software Assurance (CSA): Future Trends in Validation

Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software

Advancements in technology have forced organizations to rethink business models.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

3-Hours Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. The rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.

Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Carolyn Troiano

Current Trends in FDA Compliance and Enforcement for Regulated Computer Systems and Data

Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to the FDA.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences

This seminar will begin with a general discussion of technical writing and its role within the life sciences.

Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Charles H. Paul

4-Hour Virtual Seminar on Project Management for Non-Project Managers

This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H. Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Susanne Manz

4-Hour Virtual Seminar on Improving Your CAPA Program - And preparing for upcoming changes to the Quality System Regulation

The FDA has spent years updating the Quality System Regulation (QSR 21 CFR, Part 820) and has finally published draft regulation on February 22, 2022 to harmonize the QSR with ISO 13485:2016. If you’re thinking of improvements to your CAPA process, this is the right time to incorporate ISO13485. This seminar will help you prepare for upcoming changes to the QSR and improve your CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
John E Lincoln

4-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future

One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.

Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
John E Lincoln

6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations

This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).

Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Tom Fragale

6-Hour Virtual Seminar on Bootcamp on Excel

In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.

Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Tom Fragale

4-Hour Virtual Seminar on Bootcamp on Excel

In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.

Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Mike Thomas

Excel - Quick Tips to Help You be More Productive

Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"

Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Mastering Lookup Functions

"How do I look up a value in list ONE and pick up a related value from list TWO"

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details

Excel - Creating an Interactive Dashboard

No matter what business you are in, a dashboard is a critical tool in your communication armory and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel is commonly used due to its power, it's flexibility, and the fact that most people have it installed on their computers.

View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Power Query for the Everyday Excel User - Part 1

Turn bad data into great data in minutes!

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - 10 Must-Know Functions to Boost Your Productivity

Microsoft Excel contains almost 500 built-in worksheet functions. Strip away the ones nobody uses. Discount the ones that have a specialized use-case and you're left with a small set of functions that all Excel users should know, regardless of their job function, industry, or business sector. This webinar covers ten of Excel’s most popular productivity-boosting functions.

Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mike Thomas

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.

Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Mike Thomas

Outlook - Master your Mailbox - Inbox Hero Inbox Zero

For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel Basics - Data Visualization - Creating Effective Charts

"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Ginette Collazo

How to Write SOP's that Avoid Human Error

This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOPs to reduce the likelihood of human errors.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

How to Write SOP's for Human Error Reduction

Human error is known to be the primary cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Human Error Reduction Techniques for Floor Supervisors

Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

The Human Error Tool Box: A Practical Approach to Human Error

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 Conformance for Medical Devices

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Human Factors/ Usability Studies following ISO62366 , the FDA Guidance and the new FDA Draft Guidance

Human Factors/ Usability is the analysis of how users interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. Required documentation will be explained.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Medical Device Cybersecurity following latest FDA Guidance

The company must establish a program where they identify, analyze and control cybersecurity risks for both pre-market and post-market. The cybersecurity program must be carefully planned. A formal special hazard analysis must be conducted for each risk. Communication of risks must be sent to devise users.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

How to Prepare for and host an FDA Inspection and respond to 483's

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Secrets to Writing Effective SOPs for Medical Device QMS

Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.

Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Susanne Manz

Death by CAPA - Does your Company have the Symptoms?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices

This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn about what processes need to be validated and what steps you need to take to validate processes.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Michael Brodsky

Is it Microbiological Method Verification or Validation, or Just Semantics?

This Webinar will discuss the distinction between and requirements for method validation and method verification, to comply with ISO/IEC Standard 17025 for laboratory accreditation in food/water microbiology. Quantitative and Qualitative methods have different performance measurement requirements and require different statistical analyses.

Speaker: Michael Brodsky | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

4-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future

One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.

Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
John E Lincoln

The Most Common Problems in FDA Software Verification and Validation

Software and related hardware design, development, verification, and validation are difficult to manage, document and control. This presentation focuses on the verification and validation planning and execution of software, after basic developmental testing and debugging. It includes COTS (commercial off-the-shelf) and the growing field of "cloud"-based software.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Device Changes, FDA Changes, and the 510(k)

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.

Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Ray Evans

Formulas Automatic Calculation and Key Functions in Excel

Understand and work effectively with fundamental and versatile calculation and analysis techniques in Excel at the introductory level.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Excel - Mastering Lookup Functions

"How do I look up a value in list ONE and pick up a related value from list TWO"

Speaker: Ray Evans | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John C. Fetzer

Validation of HPLC/UPLC Methodologies

This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John C. Fetzer

The Transfer of Validated Methods

This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel Pivot Tables , Pivot Charts, Slicers, and Timelines

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel: Tips and Tricks and Shortcuts

Microsoft Excel has become the de facto spreadsheet application for business.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Ginette Collazo

How to Write SOP's that Avoid Human Error

This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOPs to reduce the likelihood of human errors.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dennis Taylor

2-Hour Virtual Seminar on Mastering Excel Pivot Tables

Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.

Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Dennis Taylor

Excel Formulas and Functions

Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel Pivot Tables , Pivot Charts, Slicers, and Timelines

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel: Tips and Tricks and Shortcuts

Microsoft Excel has become the de facto spreadsheet application for business.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Charles H. Paul

6-Hour Virtual Seminar on Project Management for Non-Project Managers

This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - How to Effectively Monitor and Control your Project

This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.

Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Gwendolyn Wise-Blackman

3-Hour Virtual Seminar on Bioanalytical Method Validation

The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics.

Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Gwendolyn Wise-Blackman

Validation Challenges for Bioassays

Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.

Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Computer System Validation (CSV) and Computer Software Assurance (CSA): Future Trends in Validation

Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Medical Device Cybersecurity and FDA Compliance

This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices

This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

The Human Error Tool box: A Practical Approach to Human Error

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dennis Taylor

2-Hour Virtual Seminar on Mastering Excel Pivot Tables

Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.

Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Dennis Taylor

Excel Formulas and Functions

Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Time-Saving Excel Tips, Tricks and 100 Shortcuts

Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Creating an Interactive Dashboard

No matter what business you are in, a dashboard is a critical tool in your communication armory and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel is commonly used due to its power, it's flexibility, and the fact that most people have it installed on their computers.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Quick Tips to Help You be More Productive

Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"

Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mike Thomas

Outlook - Master your Mailbox - Inbox Hero Inbox Zero

For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel Basics - Data Visualization - Creating Effective Charts

"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Medical Device Hazard analysis following ISO 14971

The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post-production risk management program to be implemented.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John C. Fetzer

Analytical Method Validation Under Good Laboratory Practices - GLPs

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Ray Evans

Mastering Data and Information Management Essentials

Skills to effectively manage, present and communicate data are now vital in the competitive financial and business analysis fields and offer vast opportunities to expand accounting client services and career paths.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Using Excel PivotTables to Easily Summarize and Analyze Data

The ability to analyze data is a powerful skill that helps make better decisions. Microsoft Excel is one of the top tools for data analysis and PivotTables is arguably the most popular analytic tool.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ray Evans

Pivot Table Essentials for Data Analytics in Excel

A PivotTable displays a summary of a selected data set in a condensed format of rows, columns, data fields, and pages. These components can be "pivoted" with your mouse allowing you to expand, isolate, calculate, and group the particular data in real-time. This table empowers the user to view and analyze large amounts of information.

Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel Pivot Tables, Pivot Charts, Slicers, and Timelines

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel PowerPivot and Power Query

If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel: Tips and Tricks and Shortcuts

Microsoft Excel has become the de facto spreadsheet application for business.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tom Fragale

6-Hour Virtual Seminar on Bootcamp on Excel

In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.

Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Susanne Manz

4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Carolyn Troiano