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Product image for 2 Day Virtual Seminar on REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance

2 Day Virtual Seminar on REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance

April 20-21, 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 Computer System Validation ( CSV) 3 Day Seminar

Computer System Validation ( CSV) 3 Day Seminar

Apr 13-15 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 Intro to Medical Device Submission - 510(k)s, PMAs & Exemptions

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

Apr 14 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 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

Apr 16 describes exactly what is required for compliance with Part 11

Course•By David Nettleton

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Product image for Quality Control Laboratory Compliance - cGMPs and GLPs

Quality Control Laboratory Compliance - cGMPs and GLPs

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 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 Software Verification and Validation - The 10 Must Have Documents

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.

Course•By John E Lincoln

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

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.

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

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

Course•By Travis Austin MacKay

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Product image for Analytical Methods Validation for FDA Compliance

Analytical Methods Validation for FDA Compliance

May 07-08 In this course, general guideline for the determination of the analytical

Course•By Kelly Thomas

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Product image for QMS 101: Quality Management System Guide

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

Course•By John E Lincoln

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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 Inspection Seminar

FDA Inspection Seminar

May 13-14 This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter

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 This 2-day course will cover managing a supplier for the entire lifecycle of the relationship, beginning with identification and qualification

Course•By Kelly Thomas

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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

Biostatistics for the Non-Statistician

26-28 May 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 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 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 The 6 Most Common Problems in FDA Software Validation and Verification

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

Course•By David Nettleton

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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 This seminar will help you to Understand FDA's recall authority and policy

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

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

Jun 15-16 In this seminar, you will learn just how to transition your validation work from classic Computer System Validation (CSV) to Computer Software Assurance (CSA), based on the 2022 draft guidance from FDA, and now the final guidance issued in September 2025 for medical device companies

Course•By Carolyn Troiano

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Product image for Pharmaceutical Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy

Pharmaceutical Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy

Jun 15-18 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 Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

24-25 Jun The lifecycle concept, new to these Guidance, link product and process development, qualification

Course•By Barry A. Friedman

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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 GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries

GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries

Jul 06-07 GMP Auditing for the Pharmaceutical Industry

Course•By Kelly Thomas

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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 for Med Devices ,Pharma and Biotech

Technical Writing for Med Devices ,Pharma and Biotech

Jul 20-23 This virtual seminar will walk you through the technical writing process from start to finish. Each critical aspect of writing technical documents

Course•By Charles H. Paul

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Product image for Good Manufacturing Practices (cGMP) Training

Good Manufacturing Practices (cGMP) Training

Jul 27-30 Our 4 Half-days long GMP training will equip you to increase your efficiency and strengthen your skills for a stellar career in the industry. Whether you want to level up your designation or become an entrepreneur, the credibility of a GMP course will only add stars to your portfolio.

Course•By Kelly Thomas

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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

The Drug Development Process from Concept to Market

Aug 10-13 This 4 Half Day Virtual Seminar is designed to teach employees of pharmaceutical companies

Course•By Kelly Thomas

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Product image for Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies

Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies

Aug 17-20 This webinar will define what are the US FDA's expectation for proper laboratory practices, systems, equipment usage, and documentation / record-keeping

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

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 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 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 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 US Regulation of Advertising and Promotion for Drugs and Biologics

US Regulation of Advertising and Promotion for Drugs and Biologics

MP3 Download This 2-day live online training is designed for professionals in Regulatory Affairs, Legal, Compliance, Medical Affairs, and Marketing

Course•By David R. Dills

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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

MP3 Download 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 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 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 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 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

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 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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