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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

Sep 22-24 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 Supplier and Contract Manufacturer Management

Supplier and Contract Manufacturer Management

Sep 23-24 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 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 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 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 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 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 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 Analytical Method Validation, Verification & Transfer – FDA & ICH Compliance Training (2 Day)

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

MP3 Download 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 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 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 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 Efficient Batch Record Design & Review Training

Efficient Batch Record Design & Review Training

MP3 Download 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 cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA

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

MP3 Download 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 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 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 The Drug Development Process from Concept to Market Course

The Drug Development Process from Concept to Market Course

MP3 Download 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 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 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 GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries

GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries

MP3 Download GMP Auditing for the Pharmaceutical Industry

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

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 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

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 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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Product image for Fundamentals of Part 11 Webinar

Fundamentals of Part 11 Webinar

MP3 Download 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 Risk Management for AI in Medical Devices: FDA’s Life Cycle Management Guidance

Risk Management for AI in Medical Devices: FDA’s Life Cycle Management 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 Software Verification and Validation - The 10 Must Have Documents

Software Verification and Validation - The 10 Must Have Documents

MP3 Download 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.

Course•By John E Lincoln

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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 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 Generative AI is a type of artificial intelligence (AI) that attempts to match or surpass human thinking abilities across a wide range of large data tasks.

Course•By John E Lincoln

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Product image for The EU Clinical Trial Regulation - EU Filings & Registrations 6 hrs Course Online

The EU Clinical Trial Regulation - EU Filings & Registrations 6 hrs Course Online

MP3 Download Gain a comprehensive and practical understanding of EU Clinical Trial Regulation (EU CTR 536/2014) and learn how to manage filings, submissions, and regulatory processes effectively across the European Union.

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 AI in Drug Development

AI in Drug Development

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

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 Computer System Validation (CSV) Basics

Computer System Validation (CSV) Basics

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

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.

Course•By John E Lincoln

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

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

Course•By Barry A. Friedman

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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 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

2-Day Virtual Seminar on Raw Material Compliance This comprehensive course covers critical requirements from Health Canada, USP, and EP standards, focusing on practical strategies to manage raw material sourcing, testing, and documentation.

Course•By Barry A. Friedman

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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 Preparing the CMC Section for NDAs/INDs/CTDs

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.

Course•By John E Lincoln

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

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

Course•By Carolyn Troiano

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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 GMPs for MICROBIOLOGISTS — The Manufacturing Environment

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

Course•By Barry A. Friedman

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