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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

Oct 13-15, 2026, This Auditing and Qualifying Suppliers and Vendors Course

Course•By Kelly Thomas

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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)

Oct 19-20 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 Validating FDA-Regulated Systems Supporting Drug Development & Submissions Using AI, ML & LLMs, such as ChatGPT

Validating FDA-Regulated Systems Supporting Drug Development & Submissions Using AI, ML & LLMs, such as ChatGPT

Oct 19 | Nov 05 This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco.

Course•By Carolyn Troiano

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Product image for Part 11-AI updated

Part 11-AI updated

Oct 22 describes exactly what is required for compliance with Part 11

Course•By David Nettleton

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Product image for Statistical Process Control (SPC) Training

Statistical Process Control (SPC) Training

Oct 22 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 cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA

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

Oct 26 | Nov 05 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 GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries

GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries

Oct 26-27 GMP Auditing for the Pharmaceutical Industry

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

Oct 27-29 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 Intro to Medical Device Submission - 510(k)s, PMAs & Exemptions

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

Oct 28 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 Computer System Validation ( CSV) 3 Day Seminar

Computer System Validation ( CSV) 3 Day Seminar

November 2-4, 2026 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 REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance

REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance

Nov 04-05 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 Regulatory Compliance for Dietary Supplements in the US, EU and Canada

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

Nov 04-05 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 Good Manufacturing Practices (cGMP) 12 hrs Training Online

Good Manufacturing Practices (cGMP) 12 hrs Training Online

Nov 4-5 , 2026 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 Verification and Validation - Product, Equipment/Process, Software and QMS -10 Hours Course

Verification and Validation - Product, Equipment/Process, Software and QMS -10 Hours Course

Nov 05-06 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 Efficient Batch Record Design & Review Training

Efficient Batch Record Design & Review Training

Nov 09-10 In this accredited training, we will identify and discuss Master Batch Records (MBR), regulatory requirements, and key steps for issuance, batch record review, reconciliation, and final QA disposition

Course•By Kelly Thomas

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Product image for Device and Pharma Patient / User Risk Management

Device and Pharma Patient / User Risk Management

Nov 10 How to develop, modify and use hazard analysis and the Product Risk Management File and Report and in the QMS per ISO 14971:2019 and ICH Q9

Course•By John E Lincoln

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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

Nov 12-13 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 FDA Inspection Readiness in the AI Era 2026

FDA Inspection Readiness in the AI Era 2026

Nov 16-17, 2026, Understand how FDA AI-driven targeting may impact inspections

Course•By Kelly Thomas

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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

Nov 18-19 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 Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

Nov 19 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 Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course

Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course

Nov 23-24 Pharmacovigilance Auditing Inspection course will explain how to prepare for the audit

Course•By Michael Ramcharan

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Product image for Writing Effective SOPs & Process Documents: Meet Regulatory Requirements and Ensure GMP Compliance

Writing Effective SOPs & Process Documents: Meet Regulatory Requirements and Ensure GMP Compliance

Dec 01-03 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 The Drug Development Process from Concept to Market Course

The Drug Development Process from Concept to Market Course

Dec 01-04 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 Biostatistics for the Non-Statistician Course Online

Biostatistics for the Non-Statistician Course Online

Dec 02-03 Biostatistics courses for non-statisticians

Course•By Elaine Eisenbeisz

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Product image for From CSV to CSA: AI Validation, Data Integrity & FDA Inspection Readiness Boot Camp

From CSV to CSA: AI Validation, Data Integrity & FDA Inspection Readiness Boot Camp

Dec 03-04 this 2-day Virtual Seminar 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.

Course•By Carolyn Troiano

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Product image for Validating FDA Regulated System supporting medical device

Validating FDA Regulated System supporting medical device

Dec 03 In this webinar, you will learn just how AI, ML and LLMs, such as ChatGPT can increase efficiency and effectiveness of software development life cycle (SDLC) activities, enabling the delivery and support of computer solutions

Course•By Carolyn Troiano

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Product image for Verification and Validation of Product, Process, Equipment, QMS

Verification and Validation of Product, Process, Equipment, QMS

Dec 07 How to develop or improve upon a s company verification and validatioin, including, DQ, IQ, OQ, and PQs, or equivalents that meet U.S. FDA CGMP, ICH Q-series, and ISO 13485 requirements

Course•By John E Lincoln

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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

Dec 07-08 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 ROOT CAUSE ANALYSIS (RCA), DEVIATIONS & CAPA EFFECTIVENESS FOR FDA-REGULATED INDUSTRIES .

ROOT CAUSE ANALYSIS (RCA), DEVIATIONS & CAPA EFFECTIVENESS FOR FDA-REGULATED INDUSTRIES .

Dec 08-10, 2026 You will gain a clear understanding of how to move beyond superficial fixes and develop data-driven, scientifically sound solutions that stand up to regulatory scrutiny.

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)

Dec 09-10 This training provides a practical, step-by-step approach to analytical method validation, verification, and transfer.

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

MP3 Download Online Technical Writing Course for pharmaceutical, biotech, and medical device professionals.

Course•By Charles H. Paul

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Product image for Master Validation Plan for FDA cGMP Compliance Training Course

Master Validation Plan for FDA cGMP Compliance Training Course

MP3 Download

Course•By John E Lincoln

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Product image for Mastering Out-of-Specification (OOS) and Out-of-Trend (OOT) Investigations in Pharmaceutical Manufacturing

Mastering Out-of-Specification (OOS) and Out-of-Trend (OOT) Investigations in Pharmaceutical Manufacturing

MP3 Download 4-Part Live Training Program

Course•By Kelly Thomas

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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

MP3 Download Join our 2-day online FDA Recalls course online to learn proactive strategies for recall preparation and post-recall compliance.

Course•By Kelly Thomas

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Product image for The FDA’s New CSA – Computer Software Assurance

The FDA’s New CSA – Computer Software Assurance

MP3 Download This webinar will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements

Course•By John E Lincoln

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

SaMD Classification & Compliance - US vs. EU Pathways"

MP3 Download 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 and Contract Manufacturer Management

Supplier and Contract Manufacturer Management

MP3 Download 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 Free Webinar by Kelly on RCA

Free Webinar by Kelly on RCA

MP3 Download Participants will learn how to distinguish between symptoms, immediate causes, contributing factors, and true root causes, apply practical RCA techniques

Course•By Kelly Thomas

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Product image for The DHF, DMR, DHR and Technical Documentation in the EU/US

The DHF, DMR, DHR and Technical Documentation in the EU/US

MP3 Download This Webinar will discuss the latest U.S. FDA and European Union requirements on Design History File, and Technical File/Design Dossier

Course•By John E Lincoln

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Product image for Implementing an FDA Compliant Stability Program

Implementing an FDA Compliant Stability Program

MP3 Download 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 Patient/User Device Risk Management Integration: ISO 14971 in a QMSR World

Patient/User Device Risk Management Integration: ISO 14971 in a QMSR World

MP3 Download How to develop, modify and use hazard analysis and the Product Risk Management File and Report per ISO 14971:2019 and The New QMSR

Course•By John E Lincoln

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Product image for Practical ICH Q10 Pharmaceutical Quality System (PQS) Implementation Training

Practical ICH Q10 Pharmaceutical Quality System (PQS) Implementation Training

MP3 Download Participants will gain a comprehensive understanding of the ICH Q10 model, Quality Risk Management (ICH Q9(R1)), CAPA, Change Management, Supplier Quality Management, Process Performance and Product Quality Monitoring, Management Review, and Inspection Readiness.

Course•By Kelly Thomas

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

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

MP3 Download 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 Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech

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

MP3 Download 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 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 US FDA Inspections under the new Medical Device QMSR / 21 CFR 820 / ISO 13485

US FDA Inspections under the new Medical Device QMSR / 21 CFR 820 / ISO 13485

MP3 Download 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.

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"

MP3 Download 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 GMP Data Integrity Best Practices and Regulatory Expectations for the Pharmaceutical Industry

GMP Data Integrity Best Practices and Regulatory Expectations for the Pharmaceutical Industry

MP3 Download A Comprehensive Review of the Latest MHRA Data Integrity Definitions and Guidances Including the FDA’s Most Recent Guidance

Course•By Carolyn Troiano

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Product image for How to use ChatGPT & AI for Project Management of Computer System Validation to Improve FDA Compliance

How to use ChatGPT & AI for Project Management of Computer System Validation to Improve FDA Compliance

MP3 Download In this webinar, we’ll discuss using a project management approach and techniques to validate a computer system regulated by FDA. In addition, we’ll talk about the 5 phases of a project, showing how these align with validation.

Course•By Carolyn Troiano

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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

MP3 Download 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 Validating FDA-Regulated Systems Supporting Drug Development & Submissions Using AI, ML & LLMs, such as ChatGPT

Validating FDA-Regulated Systems Supporting Drug Development & Submissions Using AI, ML & LLMs, such as ChatGPT

MP3 Download This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco.

Course•By Carolyn Troiano

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Product image for Master Validation Planning – The Unwritten Requirements

Master Validation Planning – The Unwritten Requirements

MP3 Download 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 Spreadsheet Validation Webinar

Spreadsheet Validation Webinar

MP3 Download 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 FDA Inspections 2 Day Virtual Seminar Online

FDA Inspections 2 Day Virtual Seminar Online

MP3 Download 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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