• 20
  • June
  • 2024
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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.

Susanne Manz Susanne Manz | Duration: 90 Minutes | Price: $150.00 | View Details
  • 20
  • June
  • 2024
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Bank Enforcement Actions 2024: What happened and what Can We Learn

We will go through the different banking regulators and discuss recent enforcement actions. The goal of this training is to take away the lessons learned by prior enforcement actions, implementing changes within your compliance framework, continue with your risk mitigation efforts and manage your reputational risk when similar issues arise.

Justin Muscolino Justin Muscolino | Duration: 60 Minutes | Price: $150.00 | View Details
  • 21
  • June
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $150.00 | View Details
  • 21
  • June
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

User-Centered Design in Drug and Medical Device Development

This 90-minute webinar offers a comprehensive exploration of the fundamental principles and practical applications of user-centered design (UCD) within the realm of pharmaceuticals and medical device development.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $150.00 | View Details
  • 21
  • June
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Michael Esposito Michael Esposito | Duration: 90 Minutes | Price: $150.00 | View Details
  • 21
  • June
  • 2024
  • Friday
12:00 PM PDT | 03:00 PM EDT

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.

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $150.00 | View Details
  • 21
  • June
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Robert J. Russell Robert J. Russell | Duration: 3 Hours | Price: $290.00 | View Details
  • 24
  • June
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $150.00 | View Details
  • 24
  • June
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $150.00 | View Details
  • 24
  • June
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $150.00 | View Details
  • 24
  • June
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $150.00 | View Details
  • 25
  • June
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Essentials of Validation - IQ OQ PQ

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

Susanne Manz Susanne Manz | Duration: 90 Minutes | Price: $150.00 | View Details
  • 25
  • June
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $150.00 | View Details
  • 25
  • June
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Digital Assets & The Associated Compliance Risks

We must be aware of the compliance risks that are relevant with digital assets, specifically, cryptocurrencies. This regulatory landscape for cryptocurrencies is starting to move in the right direction and we could see some drastic movement in 2024. Justin will go through the recent developments to help you prepare in 2024

Justin Muscolino Justin Muscolino | Duration: 60 Minutes | Price: $150.00 | View Details
  • 25
  • June
  • 2024
  • Tuesday
08:00 AM PDT | 11:00 AM EDT

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.

Robert J. Russell Robert J. Russell | Duration: 6 Hours | Price: $545.00 | View Details
  • 26
  • June
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $150.00 | View Details
  • 26
  • June
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $150.00 | View Details
  • 26
  • June
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $150.00 | View Details
  • 27
  • June
  • 2024
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Excel - Mastering Lookup Functions

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

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $150.00 | View Details
  • 27
  • June
  • 2024
  • Thursday
09:00 AM PDT | 12:00 PM EDT

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.

Justin Muscolino Justin Muscolino | Duration: 60 Minutes | Price: $150.00 | View Details
  • 27
  • June
  • 2024
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $150.00 | View Details
  • 28
  • June
  • 2024
  • Friday
11:30 AM PDT | 02:30 PM EDT

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.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $150.00 | View Details
  • 28
  • June
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

Quality Management Do's and Don't's

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

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $150.00 | View Details
  • 28
  • June
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Susanne Manz Susanne Manz | Duration: 90 Minutes | Price: $150.00 | View Details
  • 28
  • June
  • 2024
  • Friday
08:00 AM PDT | 11:00 AM EDT

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.

Tom Fragale Tom Fragale | Duration: 4 Hours | Price: $445.00 | View Details
  • 1
  • July
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

From 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.

Meredith Crabtree Meredith Crabtree | Duration: 90 Minutes | Price: $150.00 | View Details
  • 1
  • July
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Mike Thomas Mike Thomas | Duration: 3 Hours | Price: $290.00 | View Details
  • 1
  • July
  • 2024
  • Monday
11:30 AM PDT | 02:30 PM EDT

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.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $150.00 | View Details
  • 1
  • July
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $150.00 | View Details
  • 1
  • July
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $150.00 | View Details
  • 2
  • July
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $150.00 | View Details
  • 2
  • July
  • 2024
  • Tuesday
08:00 AM PDT | 11:00 AM EDT

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.

John E Lincoln John E Lincoln | Duration: 6 Hours | Price: $545.00 | View Details
  • 3
  • July
  • 2024
  • Wednesday
09:00 AM PDT | 12:00 PM EDT

3-Hour Virtual Seminar on IQ, OQ, and PQ in the Verification and Validation Process

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

Susanne Manz Susanne Manz | Duration: 3 Hours | Price: $290.00 | View Details
  • 3
  • July
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Risk-Based Validation of Spreadsheet Applications

We will explore the best practices and strategic approach for evaluating Excel spreadsheets 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.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $150.00 | View Details
  • 3
  • July
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Data Integrity And Human Error

Data integrity refers to the accuracy, completeness, and consistency of data over its entire lifecycle.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $150.00 | View Details
  • 5
  • July
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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?"

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $150.00 | View Details
  • 8
  • July
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $150.00 | View Details
  • 8
  • July
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Dev Strischek Dev Strischek | Duration: 90 Minutes | Price: $150.00 | View Details
  • 8
  • July
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $150.00 | View Details
  • 9
  • July
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Understanding How Quality Management Works

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

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $150.00 | View Details
  • 9
  • July
  • 2024
  • Tuesday
11:30 AM PDT | 02:30 PM EDT

Outlook Email Calendar & Contacts Essentials Masterclass

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

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $150.00 | View Details
  • 9
  • July
  • 2024
  • Tuesday
11:00 AM PDT | 02:00 PM EDT

10 Advanced Pivot Table Tricks - Part 1

Dive deeper into Excel Pivot Tables with our upcoming webinar, designed for those who are already familiar with the basics and ready to explore more sophisticated functionalities.

Abdelrahman Abdou Abdelrahman Abdou | Duration: 60 Minutes | Price: $150.00 | View Details
  • 9
  • July
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $150.00 | View Details
  • 10
  • July
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $150.00 | View Details
  • 10
  • July
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $150.00 | View Details
  • 10
  • July
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

2-Hour Virtual Seminar on the 6 Most Common Problems in FDA Software Validation and Verification

This Seminar describes the validation planning process with particular emphasis on avoiding six common pitfalls. Increased use of software from automated manufacturing and quality systems means increased exposure.

David Nettleton David Nettleton | Duration: 2 Hours | Price: $190.00 | View Details
  • 10
  • July
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Strategic Error Mitigation: Standard Operating Procedures for Human Error Reduction

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

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $150.00 | View Details
  • 10
  • July
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $150.00 | View Details
  • 10
  • July
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR

This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications.

David Nettleton David Nettleton | Duration: 90 Minutes | Price: $150.00 | View Details
  • 11
  • July
  • 2024
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $150.00 | View Details
  • 12
  • July
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $150.00 | View Details
  • 12
  • July
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $150.00 | View Details
  • 12
  • July
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Robert J. Russell Robert J. Russell | Duration: 4 Hours | Price: $445.00 | View Details
  • 15
  • July
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $150.00 | View Details
  • 15
  • July
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $150.00 | View Details
  • 15
  • July
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $150.00 | View Details
  • 15
  • July
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Dev Strischek Dev Strischek | Duration: 60 Minutes | Price: $150.00 | View Details
  • 15
  • July
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

John E Lincoln John E Lincoln | Duration: 3 Hours | Price: $290.00 | View Details
  • 16
  • July
  • 2024
  • Tuesday
11:00 AM PDT | 02:00 PM EDT

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."

Abdelrahman Abdou Abdelrahman Abdou | Duration: 75 Minutes | Price: $150.00 | View Details
  • 16
  • July
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $150.00 | View Details
  • 17
  • July
  • 2024
  • Wednesday
11:30 AM PDT | 02:30 PM EDT

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.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $150.00 | View Details
  • 17
  • July
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $150.00 | View Details
  • 17
  • July
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Robert J. Russell Robert J. Russell | Duration: 3 Hours | Price: $290.00 | View Details
  • 18
  • July
  • 2024
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $150.00 | View Details
  • 18
  • July
  • 2024
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $150.00 | View Details
  • 18
  • July
  • 2024
  • Thursday
09:00 AM PDT | 12:00 PM EDT

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.

Dev Strischek Dev Strischek | Duration: 90 Minutes | Price: $150.00 | View Details
  • 18
  • July
  • 2024
  • Thursday
11:00 AM PDT | 02:00 PM EDT

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.

Dev Strischek Dev Strischek | Duration: 90 Minutes | Price: $150.00 | View Details
  • 19
  • July
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $150.00 | View Details
  • 19
  • July
  • 2024
  • Friday
08:00 AM PDT | 11:00 AM EDT

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.

John E Lincoln John E Lincoln | Duration: 4 Hours | Price: $445.00 | View Details
  • 19
  • July
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Carolyn Troiano Carolyn Troiano | Duration: 3 Hours | Price: $290.00 | View Details
  • 22
  • July
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $150.00 | View Details
  • 22
  • July
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $150.00 | View Details
  • 22
  • July
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $150.00 | View Details
  • 22
  • July
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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).

Robert J. Russell Robert J. Russell | Duration: 6 Hours | Price: $545.00 | View Details
  • 23
  • July
  • 2024
  • Tuesday
08:00 AM PDT | 11:00 AM EDT

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.

John E Lincoln John E Lincoln | Duration: 3 Hours | Price: $290.00 | View Details
  • 23
  • July
  • 2024
  • Tuesday
11:30 AM PDT | 02:30 PM EDT

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.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $150.00 | View Details
  • 23
  • July
  • 2024
  • Tuesday
11:00 AM PDT | 02:00 PM EDT

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.

Abdelrahman Abdou Abdelrahman Abdou | Duration: 90 Minutes | Price: $150.00 | View Details
  • 24
  • July
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Excel - Mastering Lookup Functions

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

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $150.00 | View Details
  • 24
  • July
  • 2024
  • Wednesday
08:00 AM PDT | 11:00 AM EDT

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.

Carolyn Troiano Carolyn Troiano | Duration: 6 Hours | Price: $545.00 | View Details
  • 24
  • July
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

How to Deal with Bad Results Under GLP

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

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $150.00 | View Details
  • 24
  • July
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $150.00 | View Details
  • 25
  • July
  • 2024
  • Thursday
11:30 AM PDT | 02:30 PM EDT

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.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $150.00 | View Details
  • 26
  • July
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $150.00 | View Details
  • 26
  • July
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Dev Strischek Dev Strischek | Duration: 60 Minutes | Price: $150.00 | View Details
  • 26
  • July
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $150.00 | View Details
  • 26
  • July
  • 2024
  • Friday
08:00 AM PDT | 11:00 AM EDT

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.

John E Lincoln John E Lincoln | Duration: 6 Hours | Price: $545.00 | View Details
  • 29
  • July
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $150.00 | View Details
  • 29
  • July
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $150.00 | View Details
  • 30
  • July
  • 2024
  • Tuesday
11:00 AM PDT | 02:00 PM EDT

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.

Abdelrahman Abdou Abdelrahman Abdou | Duration: 60 Minutes | Price: $150.00 | View Details
  • 30
  • July
  • 2024
  • Tuesday
08:00 AM PDT | 11:00 AM EDT

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).

John E Lincoln John E Lincoln | Duration: 6 Hours | Price: $545.00 | View Details
  • 31
  • July
  • 2024
  • Wednesday
11:30 AM PDT | 02:30 PM EDT

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.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $150.00 | View Details
  • 31
  • July
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $150.00 | View Details
  • 31
  • July
  • 2024
  • Wednesday
08:00 AM PDT | 11:00 AM EDT

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.

Carolyn Troiano Carolyn Troiano | Duration: 4 Hours | Price: $445.00 | View Details
  • 31
  • July
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $150.00 | View Details
  • 2
  • August
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $150.00 | View Details
  • 2
  • August
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Garrett Wasny Garrett Wasny | Duration: 90 Minutes | Price: $150.00 | View Details
  • 5
  • August
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Garrett Wasny Garrett Wasny | Duration: 90 Minutes | Price: $150.00 | View Details
  • 6
  • August
  • 2024
  • Tuesday
11:00 AM PDT | 02:00 PM EDT

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.

Abdelrahman Abdou Abdelrahman Abdou | Duration: 90 Minutes | Price: $150.00 | View Details
  • 6
  • August
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $150.00 | View Details
  • 6
  • August
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

Dev Strischek Dev Strischek | Duration: 60 Minutes | Price: $150.00 | View Details
  • 7
  • August
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR

This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications.

David Nettleton David Nettleton | Duration: 90 Minutes | Price: $150.00 | View Details
  • 7
  • August
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $150.00 | View Details
  • 7
  • August
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $150.00 | View Details
  • 7
  • August
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity

This interactive webinar provides explicit details and a live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP-compliant spreadsheet application.

David Nettleton David Nettleton | Duration: 75 Minutes | Price: $150.00 | View Details
  • 9
  • August
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Dev Strischek Dev Strischek | Duration: 60 Minutes | Price: $150.00 | View Details
  • 12
  • August
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

Quality Management 101: An Enterprise Maintenance Professional's Guide

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

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $150.00 | View Details
  • 13
  • August
  • 2024
  • Tuesday
11:00 AM PDT | 02:00 PM EDT

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?

Abdelrahman Abdou Abdelrahman Abdou | Duration: 60 Minutes | Price: $150.00 | View Details
  • 13
  • August
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $150.00 | View Details
  • 13
  • August
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

Dev Strischek Dev Strischek | Duration: 60 Minutes | Price: $150.00 | View Details
  • 13
  • August
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

Carolyn Troiano Carolyn Troiano | Duration: 6 Hours | Price: $545.00 | View Details
  • 14
  • August
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $150.00 | View Details
  • 14
  • August
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $150.00 | View Details
  • 15
  • August
  • 2024
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $150.00 | View Details
  • 19
  • August
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $150.00 | View Details
  • 20
  • August
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $150.00 | View Details
  • 20
  • August
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $150.00 | View Details
  • 20
  • August
  • 2024
  • Tuesday
11:00 AM PDT | 02:00 PM EDT

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.

Abdelrahman Abdou Abdelrahman Abdou | Duration: 75 Minutes | Price: $150.00 | View Details
  • 21
  • August
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $150.00 | View Details
  • 21
  • August
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Robert J. Russell Robert J. Russell | Duration: 3 Hours | Price: $290.00 | View Details
  • 21
  • August
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $150.00 | View Details
  • 22
  • August
  • 2024
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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.

Dev Strischek Dev Strischek | Duration: 60 Minutes | Price: $150.00 | View Details
  • 22
  • August
  • 2024
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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

Garrett Wasny Garrett Wasny | Duration: 60 Minutes | Price: $150.00 | View Details
  • 26
  • August
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Carolyn Troiano Carolyn Troiano | Duration: 4 Hours | Price: $445.00 | View Details
  • 27
  • August
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Cash Flow Projections for Long-term Lending

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

Dev Strischek Dev Strischek | Duration: 60 Minutes | Price: $150.00 | View Details
  • 27
  • August
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $150.00 | View Details
  • 27
  • August
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Excel - Mastering Lookup Functions

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

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $150.00 | View Details
  • 28
  • August
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $150.00 | View Details
  • 28
  • August
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $150.00 | View Details
  • 29
  • August
  • 2024
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $150.00 | View Details
  • 30
  • August
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $150.00 | View Details
  • 30
  • August
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $150.00 | View Details
  • 2
  • September
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Mike Thomas Mike Thomas | Duration: 3 Hours | Price: $290.00 | View Details
  • 3
  • September
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

John E Lincoln John E Lincoln | Duration: 3 Hours | Price: $290.00 | View Details
  • 4
  • September
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $150.00 | View Details
  • 4
  • September
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $150.00 | View Details
  • 4
  • September
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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?"

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $150.00 | View Details
  • 5
  • September
  • 2024
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $150.00 | View Details
  • 9
  • September
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $150.00 | View Details
  • 10
  • September
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $150.00 | View Details
  • 11
  • September
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $150.00 | View Details
  • 11
  • September
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity

This interactive webinar explains how to configure and validate a GxP compliant spreadsheet applications to avoid FDA 483s.

David Nettleton David Nettleton | Duration: 75 Minutes | Price: $150.00 | View Details
  • 11
  • September
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $150.00 | View Details
  • 11
  • September
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

2-Hour Virtual Seminar on the 6 Most Common Problems in FDA Software Validation and Verification

This 2-Hour Seminar describes the validation planning process with particular emphasis on avoiding six common pitfalls.

David Nettleton David Nettleton | Duration: 2 Hours | Price: $190.00 | View Details
  • 17
  • September
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $150.00 | View Details
  • 17
  • September
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $150.00 | View Details
  • 18
  • September
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $150.00 | View Details
  • 18
  • September
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Robert J. Russell Robert J. Russell | Duration: 3 Hours | Price: $290.00 | View Details
  • 23
  • September
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

John E Lincoln John E Lincoln | Duration: 3 Hours | Price: $290.00 | View Details
  • 23
  • September
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $150.00 | View Details
  • 25
  • September
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $150.00 | View Details
  • 25
  • September
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $150.00 | View Details
  • 26
  • September
  • 2024
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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.

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $150.00 | View Details
  • 27
  • September
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $150.00 | View Details
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