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Product image for 2 Day Virtual Seminar Quality Control Laboratory Compliance Training – cGMP, GLP and FDA Requirements

2 Day Virtual Seminar Quality Control Laboratory Compliance Training – cGMP, GLP and FDA Requirements

MP3 Download This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions

Course•By Kelly Thomas

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Product image for Computer System Validation (CSV) Basics

Computer System Validation (CSV) Basics

Apr 21 The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry

Course•By Carolyn Troiano

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Product image for Webinar Validating FDA-Regulated Systems Using AI, ML & LLMs, such as ChatGPT

Webinar Validating FDA-Regulated Systems Using AI, ML & LLMs, such as ChatGPT

Apr 28, 2026, Duration 90 mins, learn about how AI increasing in use in the life sciences industries, and how companies are leading the way to delivering more effective, safer, and more beneficial products as a result.

Course•By Carolyn Troiano

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Product image for Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations Training

Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations Training

May 05 The objective of this live training webinar is to develop an understanding

Course•By Kelly Thomas

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Product image for Excel Spreadsheet Validation for Part 11 to Eliminate 483s

Excel Spreadsheet Validation for Part 11 to Eliminate 483s

May 07 This session will make you a better Excel user, saving you time and costs

Course•By David Nettleton

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Product image for FDA Inspections 2 Day Virtual Seminar Online

FDA Inspections 2 Day Virtual Seminar Online

May 13-14 This 10-hour seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter. FDA inspections courses provide essential training on GMP compliance, inspection readiness, and interaction with FDA investigators, featuring topics like 483 responses and mock audits. Time 12:00 PM – 05:00 PM ET | 09:00 AM - 02:00 PM PT (US) Participants will receive a Professional Certificate with 10 hours of Continuing Education aligned with FDA Inspection

Course•By Kelly Thomas

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Product image for Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) – A Technical Documentation Training

Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) – A Technical Documentation Training

May 14 This seminar will examine the existing and proposed requirements for the U.S. FDA

Course•By John E Lincoln

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Product image for Fundamentals of Part 11 Webinar

Fundamentals of Part 11 Webinar

May 18 The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems

Course•By Carolyn Troiano

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Product image for Master Validation Planning – The Unwritten Requirements

Master Validation Planning – The Unwritten Requirements

20 May Verification and validation requirements for facilities, equipment, processes, QMS, hardware and software, have always been part of the US FDA’s GMPs.

Course•By John E Lincoln

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Product image for Biostatistics for the Non-Statistician Course Online

Biostatistics for the Non-Statistician Course Online

May 26-28, 2026 - Biostatistics courses for non-statisticians focus on interpreting data, clinical trial design, and research analysis without heavy mathematics designed for professionals in medicine, pharmaceutical, and biotech fields to master statistical concepts. Earn a Professional Certificate with 15 Hours of Continuing Education Time 12:00 PM – 05:00 PM ET (US)

Course•By Elaine Eisenbeisz

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Product image for FDA Recalls - Before You Start, and After You Finish

FDA Recalls - Before You Start, and After You Finish

Jun 08-09, 2026, Join our 2-day online FDA Recalls course online to learn proactive strategies for recall preparation and post-recall compliance. You will learn how to proactively prepare for FDA recalls, manage recall execution, understand FDA recall classifications, implement a Recall Management System, handle post-recall reporting, CAPA, and communicate effectively with the FDA.

Course•By Kelly Thomas

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Product image for The EU Clinical Trial Regulation - EU Filings & Registrations

The EU Clinical Trial Regulation - EU Filings & Registrations

Jun 09 This course covers the requirements for conducting Clinical Studies across the EU

Course•By John E Lincoln

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Product image for 20 Hour Course on Pharmaceutical Root Cause Analysis of Failures & Deviations (CAPA) Live

20 Hour Course on Pharmaceutical Root Cause Analysis of Failures & Deviations (CAPA) Live

Jun 15-18 | Time 12:00 PM – 05:00 PM ET This 20-hour root cause analysis and corrective action course is designed for personnel who are responsible for the failure and deviation investigation process in a GMP environment, specifically Root Cause Analysis for CAPA

Course•By Kelly Thomas

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Product image for CSV to CSA Transition: 21 CFR Part 11, Data Integrity, Data Privacy, & Use of AI in FDA-Regulated Systems Course

CSV to CSA Transition: 21 CFR Part 11, Data Integrity, Data Privacy, & Use of AI in FDA-Regulated Systems Course

June 16-17, 2026, this 2-day in-person workshop in Richmond, Virginia provides a practical guide to transitioning from Computer System Validation (CSV) to Computer Software Assurance (CSA) within U.S. Food and Drug Administration-regulated environments. Participants will gain a clear understanding of how to apply CSA principles while maintaining compliance with 21 CFR Part 11, data integrity, and data privacy requirements.

Course•By Carolyn Troiano

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Product image for Spreadsheet Validation Webinar

Spreadsheet Validation Webinar

June 25 This webinar is intended for those involved in planning, execution and support of computer system validation activities, working

Course•By Carolyn Troiano

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Product image for Verification and Validation - Product, Equipment/Process, Software and QMS

Verification and Validation - Product, Equipment/Process, Software and QMS

July 06-07 This seminar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation

Course•By John E Lincoln

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Product image for Cybersecurity Lifecycle Management - ISO 27001 meets MDR/IVDR"

Cybersecurity Lifecycle Management - ISO 27001 meets MDR/IVDR"

Apr 22 This focused 2-hour course provides practical guidance on implementing cybersecurity lifecycle management for medical devices under EU MDR and IVDR

Course•By Frank Stein

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Product image for SaMD Classification & Compliance - US vs. EU Pathways"

SaMD Classification & Compliance - US vs. EU Pathways"

Jul 06 This 90-minute webinar provides a systematic comparison of SaMD classification approaches, from the IMDRF framework to FDA's risk-based categorization and EU MDR Rule 11.

Course•By Frank Stein

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Product image for Supplier Audits & Vendor Qualification Training: Avoid FDA 483s and Ensure GMP Compliance

Supplier Audits & Vendor Qualification Training: Avoid FDA 483s and Ensure GMP Compliance

Jul 14-15 This eight-hour vendor qualification audit training will help you improve

Course•By Kelly Thomas

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Product image for Technical Writing 20 Hours Course for Medical Devices, Pharma and Biotech

Technical Writing 20 Hours Course for Medical Devices, Pharma and Biotech

Jul 20-23, 2026, Time 12:00 PM – 05:00 PM ET Boost your technical writing skills for medical devices, pharmaceutical, and biotech industries with this comprehensive 4-day virtual training. Designed for professionals working in regulated environments, this course focuses on creating clear, concise, and compliant technical documents aligned with requirements from the U.S. Food and Drug Administration.

Course•By Charles H. Paul

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Product image for cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA

cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA

Jul 23 This webinar will cover the key areas of how ICH Q7 was established, it's goals and object

Course•By Kelly Thomas

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Product image for Good Manufacturing Practices (cGMP) 20 hrs Training Online

Good Manufacturing Practices (cGMP) 20 hrs Training Online

Jul 27-30 - Time 12:00 PM – 05:00 PM ET Master the fundamentals of Good Manufacturing Practices (cGMP) in this engaging 4 half-day virtual training designed for pharmaceutical, biotech, and laboratory professionals, aligned with regulations from the U.S. Food and Drug Administration.

Course•By Kelly Thomas

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Product image for Computer System Validation ( CSV) 3 Day Seminar

Computer System Validation ( CSV) 3 Day Seminar

August 4-6, 2026, 3-day CSV course will teach you how to comply with key FDA and international CSV

Course•By Carolyn Troiano

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Product image for Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems

Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems

Aug 04-05 | Sep 03-04 This seminar will examine Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as well as appropriate articles

Course•By John E Lincoln

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Product image for Writing Standard Operating Procedures (SOP) Course Online & Certificate for FDA-Regulated Industry

Writing Standard Operating Procedures (SOP) Course Online & Certificate for FDA-Regulated Industry

Aug 11-13, 2026, This course will address how to write effective Standard Operating Procedures and Work Instructions in support of company

Course•By Kelly Thomas

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Product image for Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies 20 hrs Course

Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies 20 hrs Course

Aug 17-20, Time 12:00 PM – 05:00 PM ET Gain the confidence to navigate Good Laboratory Practice (GLP nonclinical) requirements with this practical online training designed for today’s laboratory professionals, aligned with OECD GLP principles and expectations from global regulators like the U.S. Food and Drug Administration and European Medicines Agency.

Course•By Kelly Thomas

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Product image for REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance

REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance

19-20 Aug This 2 day seminar will go into the specifics of the REACH and RoHS regulations

Course•By Kelly Eisenhardt

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Product image for Cleanroom Fundamentals - Regulation, Science, Design, Practice, Operation & Management

Cleanroom Fundamentals - Regulation, Science, Design, Practice, Operation & Management

Aug 25 This webinar will discuss the ISO-defined and classified cleanroom (especially US FDA-regulated) to include its systems for establishing

Course•By John E Lincoln

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Product image for 21 CFR Part 11 and Annex 11; what you need to know to pass the new regulatory inspections

21 CFR Part 11 and Annex 11; what you need to know to pass the new regulatory inspections

describes exactly what is required for compliance with Part 11

Course•By David Nettleton

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Product image for Intro to Medical Device Submission - 510(k)s, PMAs & Exemptions

Intro to Medical Device Submission - 510(k)s, PMAs & Exemptions

MP3 Download This webinar will discuss current US Federal law on the 510(k), IDE, DeNovo, and PMA and associated requirements for getting a new or substantially changed medical device through the US FDA review process and to market in the USA.

Course•By John E Lincoln

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Product image for Cloud and SaaS in GxP Webinar

Cloud and SaaS in GxP Webinar

MP3 Download In this webinar, we’ll discuss on-premise servers and software, cloud-based services, and Software-as-a-Service (SaaS) solutions

Course•By Carolyn Troiano

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Product image for Regulatory Compliance for Dietary Supplements in the US, EU and Canada

Regulatory Compliance for Dietary Supplements in the US, EU and Canada

MP3 Download This 2-day interactive virtual seminar will review the regulations that impact Dietary Supplements in the US, EU and Canada

Course•By Travis Austin MacKay

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Product image for Risk Management for AI in Medical Devices: Insights from FDA's Lifecycle Management Draft Guidance

Risk Management for AI in Medical Devices: Insights from FDA's Lifecycle Management Draft Guidance

MP3 Download This webinar will discuss information specific to devices that include artificial intelligence algorithms that make real-world modifications that the agency might require for premarket review

Course•By John E Lincoln

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Product image for ChatGPT / AI for Project Management for FDA-Regulated Companies

ChatGPT / AI for Project Management for FDA-Regulated Companies

MP3 Download This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques with ChatGPT / AI assistance

Course•By John E Lincoln

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Product image for Human Error Prevention (HEP) - Risk Factors and Strategies

Human Error Prevention (HEP) - Risk Factors and Strategies

MP3 Download This presentation focuses on the use of HEP, HRA and HEART tools to add additional review areas to Risk Management and Human Factors Analysis to effect beneficial

Course•By John E Lincoln

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Product image for FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

MP3 Download The seminar will cover what you need to do to prepare for an FDA audit, and also the importance and steps required to be certain you have audited all vendors of regulated systems appropriately.

Course•By Carolyn Troiano

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Product image for Medical software development and regulation - What to consider?

Medical software development and regulation - What to consider?

MP3 Download This compact 90-minute course provides a focused introduction to the development of medical software requirements and a deep understanding of the regulatory requirements resulting

Course•By Frank Stein

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Product image for The EU regulations for digital medical devices with AI components - A basket full of requirements - What does a manufacturer need to consider?

The EU regulations for digital medical devices with AI components - A basket full of requirements - What does a manufacturer need to consider?

MP3 Download This seminar systematically guides you through the requirements for digital medical devices with AI components in the regulatory role of manufacturer and contract developer

Course•By Frank Stein

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Product image for US FDA Medical Device Quality System (QSR) Compliance: Design Controls, Verification & Validation

US FDA Medical Device Quality System (QSR) Compliance: Design Controls, Verification & Validation

MP3 Download This seminar will provide valuable guidance to regulated companies in development and implementation of Design Control Planning and Techniques for new product development

Course•By John E Lincoln

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Product image for Risk Management for AI in Medical Devices – FDA’s TPLC Management Draft Guidance

Risk Management for AI in Medical Devices – FDA’s TPLC Management Draft Guidance

MP3 Download This webinar will cover the FDA’s total product life cycle approach and FDA’s roles and responsibilities in regulating medical devices throughout their lifecycle. The US FDA has long promoted a Risk-Based Total Product Life Cycle (TPLC)

Course•By John E Lincoln

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Product image for AI in Drug Discovery: Aligning with FDA's Latest Risk-Based Framework

AI in Drug Discovery: Aligning with FDA's Latest Risk-Based Framework

MP3 Download The use of Generitive AI in the Drug discovery and Development Process. The US FDA's encouragement of AI technology in pharma development and clinicals - their risk-based framework.

Course•By John E Lincoln

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Product image for FDA Compliance and Clinical Trial Computer System Validation Core Requirements, Expectations and Challenges

FDA Compliance and Clinical Trial Computer System Validation Core Requirements, Expectations and Challenges

MP3 Download In this two day Virtual Seminar you will learn about FDA's expectations for classifying, assessing the risk, testing, and validating a computer system used in clinical trial work.

Course•By Carolyn Troiano

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Product image for Project Management for Non-Project Managers – PM in the Life Sciences – Pharmaceutical/ Biotechnology and Medical Devices

Project Management for Non-Project Managers – PM in the Life Sciences – Pharmaceutical/ Biotechnology and Medical Devices

MP3 Download This virtual seminar will address those project management critical tasks within each project phase that must be performed

Course•By Charles H. Paul

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Product image for FDA Regulation of Artificial Intelligence/ Machine Learning

FDA Regulation of Artificial Intelligence/ Machine Learning

MP3 Download This webinar is not a programming course but will explain the present and future regulatory requirements for AI/ML

Course•By Edwin Waldbusser

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Product image for Medical Device Software Validation Meeting FDA Regulations

Medical Device Software Validation Meeting FDA Regulations

MP3 Download 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

Course•By Edwin Waldbusser

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Product image for Risk Management for Medical Devices per ISO 14971

Risk Management for Medical Devices per ISO 14971

MP3 Download This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview

Course•By Jose Mora

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Product image for Hypothesis Testing, p-values, and Inference: When Thinking Like a Statistician Makes Sense

Hypothesis Testing, p-values, and Inference: When Thinking Like a Statistician Makes Sense

MP3 Download You will learn the why and how of the scientific method, and how to view the world

Course•By Elaine Eisenbeisz

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Product image for How to write SOP's that Avoid Human Error

How to write SOP's that Avoid Human Error

MP3 Download This Webinar will discuss the primary cause of quality and production losses in many industries

Course•By Ginette Collazo

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Product image for FDA's Recent Regulation on the Use of Social Media - What It Is, How to Analyze It, Make It Work for You

FDA's Recent Regulation on the Use of Social Media - What It Is, How to Analyze It, Make It Work for You

MP3 Download This webinar will help you understand in detail the application of FDA’s guidance on the use of social media in presenting and promoting information about drug products

Course•By Carolyn Troiano

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Product image for Supervising a Human Error Free Environment: You can do a Lot More than you Think

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

MP3 Download How can we prevent human error? This 90 -minutes online course will discuss why supervision is so important in reducing and preventing human error

Course•By Ginette Collazo

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Product image for Tips for setting up a Quality System to withstand FDA Audits for Medical Device and Pharmaceutical Companies

Tips for setting up a Quality System to withstand FDA Audits for Medical Device and Pharmaceutical Companies

MP3 Download This webinar will provide a step by step approach and valuable tips for setting up a Quality System to withstand FDA Audits

Course•By Meena Chettiar

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Product image for Navigating the Medical Device Post-Market Maze and Challenges during COVID-19 Pandemic - Learn what FDA is really thinking on regulation and guidance documents

Navigating the Medical Device Post-Market Maze and Challenges during COVID-19 Pandemic - Learn what FDA is really thinking on regulation and guidance documents

MP3 Download this course will explain how to comply with complicated Complaint Handling, MDR and Recall requirements. Earl Bird. Register.

Course•By Kelly Thomas

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Product image for Learn the Latest FDA Compliance and Mobile Applications Live Webinar

Learn the Latest FDA Compliance and Mobile Applications Live Webinar

MP3 Download This topic is focused on the use of mobile applications to process data regulated by FDA. These applications may be used to collect, analyze

Course•By Carolyn Troiano

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Product image for EU MDR Implementation and Transitioning to the Deadline: Essential Tasks to Complete

EU MDR Implementation and Transitioning to the Deadline: Essential Tasks to Complete

MP3 Download This 2-day virtual seminar will go into the specifics of the European Union Medical Device Regulation (EU MDR), provide case studies and share le

Course•By Kelly Thomas

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