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

Apr 22-23 This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions

CourseBy Kelly Thomas

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Software Verification and Validation - The 10 Must Have Documents

Apr 21 The tougher FDA expects a company to develop and run a formal software V&V plan . The model presented here satisfies their requirements for all software/firmware/PLC V&V.

CourseBy John E Lincoln

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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

CourseBy Carolyn Troiano

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

Apr 28 This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco.

CourseBy Carolyn Troiano

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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

CourseBy Kelly Thomas

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Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations

May 05 Download This webinar will review the applicable regulations, walk you through real-life

CourseBy Travis Austin MacKay

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Analytical Method Validation, Verification & Transfer – FDA & ICH Compliance Training (2 Day)

May 07-08 | 12:00 PM – 05:00 PM ET This training provides a practical, step-by-step approach to analytical method validation, verification, and transfer—helping you implement compliant methods, strengthen documentation, and avoid common pitfalls seen during audits and regulatory reviews. Analytical method validation, verification, and transfer training ensures that laboratory methods are reliable, reproducible, and compliant with FDA, ICH, and USP regulations. Participants will receive a Professional Certificate with 10 hours of Continuing Education aligned with Analytical Method Validation.

CourseBy Kelly Thomas

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QMS 101: Quality Management System Guide

May 07 This webinar discusses the key parts of ISO 9001, especially how it applies to manufacturing. However, its principles can, and are, used in many different business activities

CourseBy John E Lincoln

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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

CourseBy David Nettleton

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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

CourseBy Kelly Thomas

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Supplier and Contract Manufacturer Management

May 18-19 | Time 12:00 PM – 05:00 PM ET -This 2-day course will cover managing a supplier for the entire lifecycle of the relationship, beginning with identification and qualification. Participants will receive a Professional Certificate with 10 hours of Continuing Education aligned with Supplier Management

CourseBy Kelly Thomas

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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

CourseBy Carolyn Troiano

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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.

CourseBy John E Lincoln

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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)

CourseBy Elaine Eisenbeisz

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Master Validation Plan for FDA cGMP Compliance

Jun 02 What is the FDA definition of "risk based" and how is it documented in the V&V test report. Additional recommended supporting systems / documentation

CourseBy John E Lincoln

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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.

CourseBy Kelly Thomas

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The EU Clinical Trial Regulation - EU Filings & Registrations

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

CourseBy John E Lincoln

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Pharmaceutical Root Cause Analysis of Failures & Deviations Course Online

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

CourseBy Kelly Thomas

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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.

CourseBy Carolyn Troiano

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Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation) Course Online (2 Day)

24-25 June 2026 Join this high-impact 2-day virtual seminar designed to simplify and demystify process validation under global regulatory expectations from the U.S. Food and Drug Administration and European Medicines Agency. In just 10 hours, you’ll gain a clear, practical understanding of lifecycle-based process validation—from development to commercial manufacturing. Time 11:00 AM – 04:00 PM ET | 08:00 AM - 01:00 PM PT (US)

CourseBy Barry A. Friedman

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The 6 Most Common Problems in FDA Software Validation and Verification

Jun 11 This webinar covers the fundamentals of 21 CFR Part 11, software validation

CourseBy David Nettleton

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Spreadsheet Validation Webinar

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

CourseBy Carolyn Troiano

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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

CourseBy John E Lincoln

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GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries

Jul 06-07 GMP Auditing for the Pharmaceutical Industry

CourseBy Kelly Thomas

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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

CourseBy Kelly Thomas

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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.

CourseBy Charles H. Paul

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Global Regulatory Requirements for Drug Safety & Pharmacovigilance

MP3 Download This training course is designed to give pharmaceutical and biologic companies

CourseBy Steve Jolley

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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.

CourseBy Kelly Thomas

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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

CourseBy Carolyn Troiano

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The Drug Development Process from Concept to Market - 20 Hrs Course

Aug 10-13 Time 12:00 PM – 05:00 PM ET Gain a complete understanding of the drug development process from concept to market in this 4-day virtual training, covering key stages from discovery and preclinical research to clinical trials and regulatory approval aligned with the U.S. Food and Drug Administration.

CourseBy Kelly Thomas

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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

CourseBy Kelly Thomas

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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.

CourseBy Kelly Thomas

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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

CourseBy John E Lincoln

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Implementing an FDA Compliant Stability Program

Sep 14-15 This practical, expert-led training provides a complete, real-world understanding of how to design, implement, and defend an FDA-compliant

CourseBy Kelly Thomas

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Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products 2 Day Course

MP3 Download The objective of this live, interactive WCS training seminar is to explore the role of aseptic filling to assure that manufactured product

CourseBy Barry A. Friedman

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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

CourseBy David Nettleton

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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

CourseBy Carolyn Troiano

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AI in Drug Development

MP3 Download This seminar will evaluate these stated FDA policy shifts as it applies to drug discovery and development.

CourseBy John E Lincoln

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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

CourseBy Travis Austin MacKay

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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

CourseBy John E Lincoln

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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

CourseBy Kelly Thomas

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GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials

MP3 Download This webinar will provide test scripts and rationale for a "model" for internal /self-audits.

CourseBy John E Lincoln

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Microbiological Rapid Method Sterility Testing (RMT) of Short Dated and Other Products

MP3 Download The objective of this live, interactive training Executive Conference Corp webinar

CourseBy Barry A. Friedman

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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.

CourseBy Carolyn Troiano

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Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Virtual Training

MP3 Download The objective of this FIVE HOUR/DAY, ON-LINE two day interactive seminar

CourseBy Barry A. Friedman

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Preparing the CMC Section for NDAs/INDs/CTDs

MP3 Download This webinar will discuss current US Federal law on NDAs and INDs and CMC and other associated requirements for getting a new drug through the US FDA review process and to market in the USA.

CourseBy John E Lincoln

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Validation of FDA-Regulated Systems that Incorporate Artificial Intelligence (AI) and Machine Learning (ML)

MP3 Download In this webinar, you will learn just how AI can increase efficiency and effectiveness of software development life cycle

CourseBy Carolyn Troiano

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Biostatistics for the Non-Statistician

MP3 Download this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.

CourseBy Elaine Eisenbeisz

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GMPs for MICROBIOLOGISTS — The Manufacturing Environment

MP3 Download The objective of this live, interactive Executive Conference Corp (ECC) webinar is to obtain an enhanced understanding

CourseBy Barry A. Friedman

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Understanding How Quality Management Works

MP3 Download This webinar will evaluate the requirements for the foundational / basic Quality Management System (QMS), ISO 9001m and how most QMS' requirements build upon that foundation

CourseBy John E Lincoln

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

Software Verification and Validation - The 10 Must Have Documents

Computer System Validation (CSV) Basics

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

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

Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations

Analytical Method Validation, Verification & Transfer – FDA & ICH Compliance Training (2 Day)

QMS 101: Quality Management System Guide

Excel Spreadsheet Validation for Part 11 to Eliminate 483s

FDA Inspections 2 Day Virtual Seminar Online

Supplier and Contract Manufacturer Management

Fundamentals of Part 11 Webinar

Master Validation Planning – The Unwritten Requirements

Biostatistics for the Non-Statistician Course Online

Master Validation Plan for FDA cGMP Compliance

FDA Recalls - Before You Start, and After You Finish

The EU Clinical Trial Regulation - EU Filings & Registrations

Pharmaceutical Root Cause Analysis of Failures & Deviations Course Online

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

Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation) Course Online (2 Day)

The 6 Most Common Problems in FDA Software Validation and Verification

Spreadsheet Validation Webinar

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

GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries

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

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

Global Regulatory Requirements for Drug Safety & Pharmacovigilance

Good Manufacturing Practices (cGMP) 20 hrs Training Online

Computer System Validation ( CSV) 3 Day Seminar

The Drug Development Process from Concept to Market - 20 Hrs Course

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

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

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

Implementing an FDA Compliant Stability Program

Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products 2 Day Course

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

Cloud and SaaS in GxP Webinar

AI in Drug Development

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

ChatGPT / AI for Project Management for FDA-Regulated Companies

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

GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials

Microbiological Rapid Method Sterility Testing (RMT) of Short Dated and Other Products

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

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Virtual Training

Preparing the CMC Section for NDAs/INDs/CTDs

Validation of FDA-Regulated Systems that Incorporate Artificial Intelligence (AI) and Machine Learning (ML)

Biostatistics for the Non-Statistician

GMPs for MICROBIOLOGISTS — The Manufacturing Environment

Understanding How Quality Management Works

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

Software Verification and Validation - The 10 Must Have Documents

Computer System Validation (CSV) Basics

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

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

Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations

Analytical Method Validation, Verification & Transfer – FDA & ICH Compliance Training (2 Day)

QMS 101: Quality Management System Guide

Excel Spreadsheet Validation for Part 11 to Eliminate 483s

FDA Inspections 2 Day Virtual Seminar Online

Supplier and Contract Manufacturer Management

Fundamentals of Part 11 Webinar

Master Validation Planning – The Unwritten Requirements

Biostatistics for the Non-Statistician Course Online

Master Validation Plan for FDA cGMP Compliance

FDA Recalls - Before You Start, and After You Finish

The EU Clinical Trial Regulation - EU Filings & Registrations

Pharmaceutical Root Cause Analysis of Failures & Deviations Course Online

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

Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation) Course Online (2 Day)

The 6 Most Common Problems in FDA Software Validation and Verification

Spreadsheet Validation Webinar

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

GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries

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

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