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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

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

Course•By Kelly Thomas

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

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.

Course•By Kelly Thomas

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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 Supplier and Contract Manufacturer Management

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

Course•By Kelly Thomas

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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 Master Validation Plan for FDA cGMP Compliance

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

Course•By John E Lincoln

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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 Pharmaceutical Root Cause Analysis of Failures & Deviations Course Online

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

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

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)

Course•By Barry A. Friedman

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

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.

Course•By Kelly Thomas

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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 Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech

Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech

Aug 20-21 This Course will explain how to comply with key FDA and international CSV regulations

Course•By Carolyn Troiano

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Product image for Implementing an FDA Compliant Stability Program

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

Course•By Kelly Thomas

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

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

Course•By Barry A. Friedman

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

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

Course•By Barry A. Friedman

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Product image for Statistical Process Control (SPC) Training

Statistical Process Control (SPC) Training

MP3 Download This seminar will provide attendees with the statistical tools necessary to monitor processes to ensure the quality

Course•By Elaine Eisenbeisz

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Product image for Biostatistics for the Non-Statistician

Biostatistics for the Non-Statistician

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

Course•By Elaine Eisenbeisz

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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 Global Regulatory Requirements for Drug Safety & Pharmacovigilance

Global Regulatory Requirements for Drug Safety & Pharmacovigilance

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

Course•By Steve Jolley

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Product image for 21 CFR Part 11 Compliance for SaaS/Cloud Application

21 CFR Part 11 Compliance for SaaS/Cloud Application

MP3 Download This course benefits anyone that uses computer systems to perform their job functions and is ideal for professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors

Course•By David Nettleton

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Product image for Risk-based Computer System Validation; Reduce Costs and Avoid 483s

Risk-based Computer System Validation; Reduce Costs and Avoid 483s

This course benefits anyone that uses computer systems to perform their job functions and is ideal for professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors

Course•By David Nettleton

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Product image for Computer System Validation for Cloud and COTS Applications–Live, Online Training

Computer System Validation for Cloud and COTS Applications–Live, Online Training

MP3 Download 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 Introduction to Computer System Validation

Introduction to Computer System Validation

MP3 Download This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology

Course•By Carolyn Troiano

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Product image for Basic GMP Training for the QC Laboratory

Basic GMP Training for the QC Laboratory

MP3 Download This course will provide participants with an understanding of how to effectively handle out-of-specification

Course•By Kelly Thomas

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Product image for Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course

Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course

MP3 Download Pharmacovigilance Auditing Inspection course will explain how to prepare for the audit

Course•By Michael Ramcharan

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Product image for Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)

Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)

MP3 Download In this two day workshop conference you will learn the requirements and expectation

Course•By Kelly Thomas

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Product image for Preparing for and Managing Successful FDA Inspections

Preparing for and Managing Successful FDA Inspections

Sep 03-04 This seminar, you will learn how to properly alert key members that an investigator

Course•By Danielle DeLucy

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Product image for Efficient Batch Record Review and Product Release Course

Efficient Batch Record Review and Product Release Course

MP3 Download Duration 240 Minutes

Course•By Danielle DeLucy

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Product image for Statistical Process Control (SPC) One Day Masterclass

Statistical Process Control (SPC) One Day Masterclass

MP3 Download This seminar will provide attendees with the statistical tools necessary to monitor processes to ensure the quality of manufactured products

Course•By Elaine Eisenbeisz

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Product image for 2024 Human Error Prevention & GMP Training Course - New

2024 Human Error Prevention & GMP Training Course - New

MP3 Download this training would provide tools that can be implemented and used after this event.

Course•By Ginette Collazo

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Product image for FDA’s Regulation of OTC Drug Products : What It Is, How to Analyze It, Make It Work for You

FDA’s Regulation of OTC Drug Products : What It Is, How to Analyze It, Make It Work for You

MP3 Download this training will Gain a comprehensive understanding of how OTC Drug Products are regulated in the U.S. Pharmaceutical and Biotech.

Course•By Karl M. Nobert

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Product image for Aseptic Technique and Cleanroom Behavior – Avoiding Human Error

Aseptic Technique and Cleanroom Behavior – Avoiding Human Error

MP3 Download this course we will review how quality systems helps in defining requirements for cleanrooms

Course•By Danielle DeLucy

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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 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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Product image for 3 Hrs Webinar on What You Need to Know: Investigating Out-of-Specification (OOS)

3 Hrs Webinar on What You Need to Know: Investigating Out-of-Specification (OOS)

MP3 Download This webinar will review the regulatory requirements for investigating an OOS Investigation.

Course•By Danielle DeLucy

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Product image for 2 Day Virtual Seminar on FDA Inspection Essentials in 2022

2 Day Virtual Seminar on FDA Inspection Essentials in 2022

MP3 Download This seminar, you will learn how to properly alert key members that an investigator has arrived, the proper protocol

Course•By Danielle DeLucy

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Product image for 3 Hrs Virtual Webinar on Aseptic Processing and Validation

3 Hrs Virtual Webinar on Aseptic Processing and Validation

MP3 Download This course will provide an overview of requirements for aseptic and bulk manufacturing operations, including facility design and contamination

Course•By Kelly Thomas

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Product image for 3Hour Virtual Seminar on IEC 62304 and Demystifying Software Validation using the Principles of LDLC

3Hour Virtual Seminar on IEC 62304 and Demystifying Software Validation using the Principles of LDLC

MP3 Download This session will give you a good understanding of how the IEC 62304 differs from ISO 13485. It will also cover components of the Software

Course•By Jose Mora

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Product image for Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program

Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program

MP3 Download This course will give an introduction into the Medical Device Single Audit Program (MDSAP) and how to adjust your internal audit program

Course•By Frank Stein

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Product image for Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines

Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines

MP3 Download This 2-day seminar will explain the new Analytical Procedure Lifecycle guidelines and give attendees the knowledge needed to implement recommend

Course•By Kelly Thomas

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Product image for Virtual Seminar on GAMP® Data Integrity 21 CFR Part 11 Training Course

Virtual Seminar on GAMP® Data Integrity 21 CFR Part 11 Training Course

MP3 Download This training course will provide a practical understanding of the requirement for a data governance framework

Course•By Carolyn Troiano

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