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.
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
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
Excel Formula Functions & Automatic Calculation Powerpoint 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
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
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
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
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
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
Introduction to Microsoft Power BI Dashboards
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
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.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
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
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
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
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
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
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
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
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
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.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
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
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
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
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
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
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
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
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
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
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
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: 90 Minutes | Price: $190.00 | View Details
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
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
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
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
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
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
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
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
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
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
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
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
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
How to Reduce Human Error in a GMP Manufacturing/Floor
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
Supervising a Human Error-Free Environment: You can do a Lot More than You Think
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
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.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
How to Create an Effective and GMP - Compliant Training Program and Reduce Training - Related Human Errors
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
How to Reduce Human Error in a GMP Manufacturing/Floor
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
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
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
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
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
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 - 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 - 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
3-Hour Virtual Seminar on Bootcamp on Quality Management System (QMS) - Per ISO and US FDA's GMPs
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
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
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
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
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
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
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
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
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
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
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
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
Unleashing the Power of Excel: Exploring the Latest Regular Expressions (REGEX) Functions
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: 60 Minutes | Price: $190.00 | View Details
Enhancing Pivot Tables with Images: Visualize Your Data Like a Pro
Are you looking to elevate your Excel skills and create more engaging and visually appealing reports? Join our upcoming webinar, "Enhancing Data Visualization in Excel with Embedded Images in Pivot Tables, "where we will dive into one of the latest and most exciting features in Excel: the ability to embed images directly into Pivot Tables. This innovative functionality can transform your data presentation, making it more dynamic and easier to interpret.
Speaker: Abdelrahman Abdou | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel Power Tools: Unlocking the Full Potential of What-If Analysis with Goal Seek, Solver, and Data Tables
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: 60 Minutes | Price: $190.00 | View Details
Revolutionize Data Analysis: Are GROUPBY and PIVOTBY the New Pivot Table Champions?
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: 60 Minutes | Price: $190.00 | View Details
Mastering Excel Pivot Tables: Top 10 Advanced Techniques - 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.
Speaker: Abdelrahman Abdou | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
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
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
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
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
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
3-Hour Virtual Seminar on Chat GPT for Project Management in FDA Regulated Environment
This comprehensive three-hour virtual seminar, titled "Mastering AI Integration in Project Management: Leveraging ChatGPT for Enhanced Efficiency and Compliance in FDA-Regulated Industries," is designed to provide project management professionals with a thorough understanding of the practical applications of AI tools like ChatGPT.
Speaker: Charles H. Paul | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
ChatGPT & AI for Project Management for FDA-Regulated Companies
This 90-minute webinar is designed to provide project management professionals with comprehensive insights into the practical applications of AI tools like ChatGPT.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
ChatGPT and Project Management: Leveraging AI for Project Management Excellence
The integration of artificial intelligence (AI) into project management is transforming the way projects are planned, executed, and monitored.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
4-Hour Virtual Seminar on The Project Management Course: Beginner to Project Manager
It is not possible to present a complete treatment of project management in the span of 4-hours. It is however, possible to focus in on those most important aspects of project management that are critical to the success of any project. Without basic tools, it is not possible to effectively manage a project to the pre-determined end-date without turmoil and chaos.
Speaker: Charles H. Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
4-Hour Virtual Seminar on ChatGPT for Project Management: From Basics to Advanced
Participants will want to attend this seminar to gain practical and actionable skills that will revolutionize their approach to project management.
Speaker: Charles H. Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
ChatGPT & AI for Project Management
This 90-minute webinar will begin with an introduction to the fundamentals of project management, tailored specifically for those who may not have formal training in the field.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
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
Project Management 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
Cybersecurity 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
ChatGPT & AI for Project Management for FDA-Regulated Companies
This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques with ChatGPT / AI assistance for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 - 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
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
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
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
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
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
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
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
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
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
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 - 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 - 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.jpg "Dr. Kimberly N. West - Complinace4All")
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 - 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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, 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 DetailsExcel - 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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