Dealing with Out of Specification Test Results in FDA Regulated Industries

MP3 Download This webinar with a thorough knowledge on what is allowed and what is not allowed and areas that need to be looked at for a thorough investigation

Meena Chettiar

$199

Tips for setting up a Quality System to withstand FDA Audits for Medical Device and Pharmaceutical Companies

MP3 Download This webinar will provide a step by step approach and valuable tips for setting up a Quality System to withstand FDA Audits

Meena Chettiar

$199

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

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

Barry A. Friedman

$299

FDA Recalls - Before You Start, and After You Finish

MP3 Download this seminar will help you to Understand FDA's recall authority and policy , Learn how to manage recalls under FDA oversight.

Kelly Thomas

€1.595

The Validation Master Plan - The Unwritten Requirements

MP3 Download This 60-minute session on master verification and validation planning will discuss the major cGMP deficiencies and "must have" elements from the U.S

John E Lincoln

$199

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.

Barry A. Friedman

$199

A risk based approach to GxP Compliant Laboratory Computerized Systems in the COVID-19 Era and Beyond

MP3 Download This hands-on seminar provides a practical, risk based approach to laboratory computerized system specification, verification, and implementation

Carolyn Troiano

$1,295

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.

Kelly Thomas

$1,495

FDA Regulation of Artificial Intelligence/ Machine Learning

MP3 Download This webinar is not a programming course but will explain the present and future regulatory requirements for AI/ML

Edwin Waldbusser

$265

Data Integrity -- US FDA Requirements

MP3 Download This webinar will focus on the key issues raised by the FDA, not just for products and their manufacture, but expectations

John E Lincoln

$199

Learn the Latest FDA Compliance and Mobile Applications Live Webinar

MP3 Download This topic is focused on the use of mobile applications to process data regulated by FDA. These applications may be used to collect, analyze

Carolyn Troiano

$299

Computer System Validation for Cloud and COTS Applications

MP3 Download The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry

Carolyn Troiano

$1,495

Biostatistics for the Non-Statistician

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

Elaine Eisenbeisz

€4.665

GMP for Active Pharmaceutical Ingredients

MP3 Download This webinar reviews the requirements for good manufacturing practices for active pharmaceutical ingredients.

Paul Larocque

$265

FDA Computer System Validation ( CSV) Training 3 Days Virtual Seminar

MP3 Download This Course will explain how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11.

Carolyn Troiano

$1,295

Calculations for Process and Product Capability

MP3 Download This Webinar will focus on providing the information needed for attendees to know the appropriate measures and formulas

Elaine Eisenbeisz

$249

CMO Supplier Quality Agreements - What you need to know to comply with new FDA & EU GMP Guidelines for contract drug manufacture

MP3 Download This Webinar presentation will provide a thorough understanding of the content that is expected in Quality Agreements from a regulatory

Roger Cowan

$299

Analytical Method Validation and Transfer

MP3 Download This course will provide a thorough review of regulatory guidelines on method validation and transfer

Kelly Thomas

$229

Cybersecurity - US FDA Requirements – New Course !

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

John E Lincoln

$249

Purchasing Controls, Receiving Inspection, and Supplier Audit – what to do during a global pandemic

MP3 Download This webinar will provide insights into how to use remote auditing techniques to minimize the risk and maximize the benefits of conducting audits

Susanne Manz

$249

Introduction to Medical Device Quality System Regulations

MP3 Download Attendees will learn FDA’s expectations for the implementation and on-going operation of an effective medical device

Paul Larocque

$265

Quality Systems Inspection Technique (QSIT), and How to use it to Your Advantage

MP3 Download This Webinar provides valuable assistance to all individuals who liaison with the FDA during inspections. It will also benefit senior management

Jeff Kasoff

$249

Preventing Human Error in the Life Sciences Virtual Seminar (4 hours)

MP3 Download This four hour virtual seminar, will explore the true causes and nature of human error, how human error should be investigated

Charles H. Paul

$2,995

How FDA trains its investigators to review CAPA and what should you do to prepare

MP3 Download This webinar will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar

Jeff Kasoff

$249

Essentials of Validation - IQ, OQ, PQ

MP3 Download This course will cover the validation essentials for medical device manufacturers

Susanne Manz

$179

Computer System Validation (CSV) vs. Computer Software Assurance (CSA): Following a Waterfall vs. Agile Methodology

MP3 Download The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry.

Carolyn Troiano

$499

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

Carolyn Troiano

$1,495

Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices

MP3 Download The seminar will provide attendees with a better understanding of responsibilities and gain a greater knowledge of the issues faced

David R. Dills

$1,299

Good Documentation Practices

MP3 Download This presentation will discuss the purpose of good documentation, what proper documentation looks like and a brief discussion of elements

David W. Husman

$199

Purchasing Controls and Receiving Acceptance for Medical Devices

MP3 Download This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products

Susanne Manz

$229

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

Barry A. Friedman

$249

Lyophilization Basics for Pharmaceuticals: Unit operations, equipment, instrumentation, and performance

MP3 Download Lyophilization Basics for Pharmaceuticals: Unit operations, equipment, instrumentation, and performance

Lisa Hardwick Thompson

$595

Risk Based Verification and/or Validation to meet US FDA CGMP and ISO 13485 Requirements

MP3 Download This Webinar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning.

John E Lincoln

$199

Analytical Method Validation, Verification and Transfer

MP3 Download In this course, general guideline for the determination of the analytical characteristics for different types of validation procedures

Kelly Thomas

$1,498

Biomarkers in Drug Discovery and Development

MP3 Download The topics that will be discussed potential benefits of a biomarker in drug development are very significant

Dr. Stefano Persiani

$199

Production and Process Controls for Medical Devices What You Need to Know

MP3 Download This webinar can help you prevent serious issues such as these. You’ll learn about FDA quality system regulation expectations, and how you can

Susanne Manz

$249