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

29 Nov 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

Project Management for Non-Project Managers

01 - 03 Dec This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective

Charles H. Paul

$1,495

Purchasing Controls and Receiving Acceptance for Medical Devices

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

Susanne Manz

$229

The Veterinary Drug Approval Process and FDA Regulatory Oversight

02-03 Dec This two-day seminar will provide attendees with an understanding of FDA’s veterinary drug approval process, obtaining federal government

Karl M. Nobert

$2,995

Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products

6-7 Dec 2021 The objective of this live, interactive WCS training seminar is to explore the role of aseptic filling to assure that manufactured product

Barry A. Friedman

$1,295

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

6-7 Dec 2021 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

Post Market Surveillance - Complaint Handling and Medical Device Reporting

06 Dec This webinar will cover the basics of complaint management and medical device reporting

Susanne Manz

$229

Statistics for Process Control

07 Dec This seminar will provide attendees with the statistical tools necessary to monitor processes to ensure the quality of manufactured products

Elaine Eisenbeisz

$795

GMP for Active Pharmaceutical Ingredients

07 Dec This webinar reviews the requirements for good manufacturing practices for active pharmaceutical ingredients.

Paul Larocque

$265

2 Day Virtual Seminar on FDA Inspection Essentials in 2022

08-09 Dec This seminar, you will learn how to properly alert key members that an investigator has arrived, the proper protocol

Danielle DeLucy

$1,295

Implementing the EU’s New Medical Device Regulation 2 Half Day Virtual Seminar Online

Dec 8-9 , 2021 This 2-day virtual seminar will go into the specifics of the European Union Medical Device Regulation (EU MDR), provide case studies and share le

Kelly Thomas

$755

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

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

Carolyn Troiano

$499

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

December 13-15, 2021 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

Computer System Validation Professional Certification Program 3 Days

Dec 13-15 3 day CSV course will teach you how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11.

Carolyn Troiano

$1,899

Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course

15-16 Dec Pharmacovigilance Auditing Inspection course will explain how to prepare for the audit inspection, overview of the European Medicines Agency's Guid

Michael Ramcharan

$2,995

Good Clinical Practice (ICH GCP) Course

14 Dec This webinar is intended to help you adequately implement Good Clinical Practices (GCP) including documentation requirements

John E Lincoln

$385

21 CFR Part 11 and Annex 11; what you need to know to pass the new regulatory inspections

15 Dec This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted

David Nettleton

$199

Write it Right – Standard Operating Procedures

13 Jan This webinar will help you to write complete, clear, unambiguous, and flexible SOPs.

Susanne Manz

$487

Complaint Management: Best Practices to Assure Regulatory Compliance and Customer Retention

18 Jan This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing

Jeff Kasoff

$249

Risk Management of Raw Materials in a GMP Environment

19 Jan The live training webinar will explore the number of lots required to be tested before reduced testing might occur

Barry A. Friedman

$385

Investigation of Out-of-Specification Test Results

25 Jan Attendees will learn the FDA expectations when investigating out-of-specification and out-of-trend laboratory results.

Paul Larocque

$265

FDA Compliance and Enforcement Trends focused on Data Integrity

26 Jan This course will enable you to best anticipate and prepare for FDA scrutiny, understand your role during inspections and audits

Carolyn Troiano

$249

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

27 Jan 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

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Virtual Training

27-28 Jan The objective of this FIVE HOUR/DAY, ON-LINE two day interactive seminar is to explore raw materials and their requirements – issues and solutions.

Barry A. Friedman

$1,495

Technical Writing for professionals in the life sciences

Feb 08-10 This virtual seminar will walk you through the technical writing process from start to finish. Each critical aspect of writing technical documents

Charles H. Paul

$1,950

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

22 Feb 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

Computer System Validation for Cloud and COTS Applications–Live, Online Training

March 02 - 04 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

DHF, DMR, DHR, Technical Documentation for US FDA, ISO and EU MDR Requirements

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

John E Lincoln

$199

6 Hours Annual Online Human Error Certification Training Program

MP3 Download this training would provide tools that can be implemented and used after this event.

Ginette Collazo

$499

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

A Comprehensive View of Medical Device Post-Market Regulations and Challenges During COVID-19— Complaint Handling, MDR Reporting and Recalls

MP3 Download this course will explain how to comply with complicated Complaint Handling, MDR and Recall requirements. Earl Bird. Register.

Rita Hoffman

$1,498

Supervising a Human Error Free Environment: You can do a Lot More than you Think

MP3 Download How can we prevent human error? This 90 -minutes online course will discuss why supervision is so important in reducing and preventing human error

Ginette Collazo

$179

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

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

$1,295

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 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