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Product image for Analytical Methods Validation for FDA Compliance

Analytical Methods Validation for FDA Compliance

Jan 14-15 In this course, general guideline for the determination of the analytical

Course•By Kelly Thomas

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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

Jan 15-16 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 FDA Recalls - Before You Start, and After You Finish

FDA Recalls - Before You Start, and After You Finish

Jan 21-22 This seminar will help you to Understand FDA's recall authority and policy

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

Jan 22-23 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 Computer System Validation ( CSV) 3 Day Seminar

Computer System Validation ( CSV) 3 Day Seminar

Jan 27 - 29 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 GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries

GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries

Jan 28-29 GMP Auditing for the Pharmaceutical Industry

Course•By Kelly Thomas

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Product image for Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach

Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach

Feb 10-12 This eight-hour vendor qualification audit training will help you improve

Course•By Kelly Thomas

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Product image for Supplier and Contract Manufacturer Management

Supplier and Contract Manufacturer Management

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

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

Mar 10-12 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 cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA

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

Apr 02 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 Efficient Batch Record Design & Review Training: GMP Compliance & FDA Requirements

Efficient Batch Record Design & Review Training: GMP Compliance & FDA Requirements

Apr 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 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

MP3 Download 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 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 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 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 Excel Spreadsheet Validation for Part 11 to Eliminate 483s

Excel Spreadsheet Validation for Part 11 to Eliminate 483s

MP3 Download 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 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 Master Validation Plan - The Unwritten Requirements

Master Validation Plan - The Unwritten Requirements

MP3 Download 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 QMS 101: Quality Management System Guide

QMS 101: Quality Management System Guide

MP3 Download 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 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 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 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 Verification and Validation - Product, Equipment/Process, Software and QMS

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

MP3 Download 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 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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Product image for Cybersecurity - The Latest US FDA Requirements

Cybersecurity - The Latest US FDA Requirements

MP3 Download This webinar will consider how cybersecurity is introduced into the CGMPs, design control (21 CFR 820.30) for devices, and post-production by update, the CAPA system, among others

Course•By John E Lincoln

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Product image for Quality Control Laboratory Compliance - cGMPs and GLPs

Quality Control Laboratory Compliance - cGMPs and GLPs

MP3 Download 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 The 6 Most Common Problems in FDA Software Validation and Verification

The 6 Most Common Problems in FDA Software Validation and Verification

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

Course•By David Nettleton

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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

Feb 03 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 Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Product

Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Product

MP3 Download In this course, you will learn the practical applications for ensuring regulatory compliance as required by FDA regulations

Course•By Karl M. Nobert

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Product image for The Microbiology of Water in a GMP Environment; USP, EP, JP and FDA Requirements for Potable Water, Purified Water, Water for Injection and Steam

The Microbiology of Water in a GMP Environment; USP, EP, JP and FDA Requirements for Potable Water, Purified Water, Water for Injection and Steam

MP3 Download This webinar will examine a variety of issues surrounding water in a facility to include the testing of each water source.

Course•By Barry A. Friedman

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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

describes exactly what is required for compliance with Part 11

Course•By David Nettleton

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Product image for Device and Software Changes and the 510(k)

Device and Software Changes and the 510(k)

MP 3 Download This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k)

Course•By John E Lincoln

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Product image for Developing an Effective Strategy for Testing Raw Materials in Phase 1 Through Phase 3 Environment

Developing an Effective Strategy for Testing Raw Materials in Phase 1 Through Phase 3 Environment

MP3 Download This live training will cover testing requirements during each Phase and what may be optional until the product moves to its next Phase

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 Technical Writing for professionals in the life sciences

Technical Writing for professionals in the life sciences

MP3 Download 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 FDA & OSHA Warehouse Requirements

FDA & OSHA Warehouse Requirements

MP3 Download The webinar will provide attendees with an overview of the FDA’s warehousing regulatory

Course•By Karl M. Nobert

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Product image for Changes to 21 CFR 820 - Device QSR to QMSR - Due February 02, 2026

Changes to 21 CFR 820 - Device QSR to QMSR - Due February 02, 2026

MP3 Download This webinar will discuss what the new QMSR will require, by including a discussion of the Final Rule and its Preamble

Course•By John E Lincoln

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Product image for FDA's Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices

FDA's Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices

MP3 Download The objective of this live training webinar is to explore the NEW/REVISED Guidances for Industry on Pyrogen and Endotoxins Testing. FDA Training

Course•By Barry A. Friedman

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Product image for Drug, Device and Combination Product Development

Drug, Device and Combination Product Development

MP3 Download Combination products are subject to a combination of CGMPs to form an "Operating System". This greatly increases compliance to the Combo Products CFMPs, 21 CFR 4. And recent problems have compounded supply chain issues.

Course•By John E Lincoln

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Product image for Introduction to Medical Combination Products

Introduction to Medical Combination Products

MP3 Download This webinar will provide valuable assistance to all regulated companies in evaluating their existing product development

Course•By John E Lincoln

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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 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 GMP Environmental Monitoring for Pharmaceutical Clean Rooms

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

MP3 Download Attend this webinar to various US and international regulatory requirements, the testing requirements for the various clean room classifications

Course•By John E Lincoln

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Product image for FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control

FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control

MP3 Download This webinar will discuss the FDA requirements and guidelines for investigating Out-of-trend (OOT) results in the pha

Course•By Kelly Thomas

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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 Technical Writing for Technical Personnel (In a Regulated Industry)

Technical Writing for Technical Personnel (In a Regulated Industry)

MP3 Download Technical writing is a specialized form of writing often used by an organization's SME"s

Course•By John E Lincoln

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Product image for The Quality System Regulation (cGMP 820) and the new QMSR

The Quality System Regulation (cGMP 820) and the new QMSR

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 Risk-Based Approach to IT Infrastructure Qualification, Compliance & Control

Risk-Based Approach to IT Infrastructure Qualification, Compliance & Control

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 FDA Compliance and Clinical Trial Computer System Validation Core Requirements, Expectations and Challenges

FDA Compliance and Clinical Trial Computer System Validation Core Requirements, Expectations and Challenges

MP3 Download In this two day Virtual Seminar you will learn about FDA's expectations for classifying, assessing the risk, testing, and validating a computer system used in clinical trial work.

Course•By Carolyn Troiano

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Product image for Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR

Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR

The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.

Course•By David Nettleton

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Product image for SPC (Statistical Process Control) / Control Charts

SPC (Statistical Process Control) / Control Charts

MP3 Download This webinar is intended to provide guidance regarding the CGMPs on manufacturing methods utilizing the US FDA Production and Process Controls for Drugs and Devices and Statistical Process Controls (SPC)

Course•By John E Lincoln

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Product image for Generative AI in Drug Discovery

Generative AI in Drug Discovery

MP3 Download The use of Generitive AI in the Drug Development Process. The US FDA's encouragement of AI technology in pharma development and clinicals.

Course•By John E Lincoln

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Product image for Drug Development: Key to Success from Concept to Commercialization

Drug Development: Key to Success from Concept to Commercialization

MP3 Download This 2 Day Virtual Seminar is designed to teach employees of pharmaceutical companies

Course•By Karl M. Nobert

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Product image for Project Management for Non-Project Managers – PM in the Life Sciences – Pharmaceutical/ Biotechnology and Medical Devices

Project Management for Non-Project Managers – PM in the Life Sciences – Pharmaceutical/ Biotechnology and Medical Devices

MP3 Download This virtual seminar will address those project management critical tasks within each project phase that must be performed

Course•By Charles H. Paul

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