FDA is Changing GMP Audit Practices: Are You Ready?

Kelly Thomas

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GMP deficiencies are responsible for most delays in market approval. FDA recently reorganized the Office of Regulatory Affairs to increase the frequency and focus of the GMP audits. Additionally FDA has launched special programs such as NIPP to further enhance GMP audit practices followed by its auditors. GMP audits are one of the most comprehensive and critical functions for FDA auditors and lead to the most FDA 483s and Warning Letters. Many of the GMP deficiencies can be easily addressed if found in time and addressed adequately. However, with the ever expanding global supply chain it is harder for sponsors to assure GMP compliance of their manufacturing sites. As a general rule, it is the responsibility of a sponsor of a marketing approval application to assure that the manufacturing sites are always prepared for an FDA audit. Manufacturing operations are complex and multi-dimensional and require well-training personnel and robust quality systems to maintain compliance. This webinar will discuss common issues with GMP sites, FDA audit preps, potential solutions and best practices based on industry best practices and FDA expectations. 

Areas Covered in the Session:

·Best ways to audit GMP sites

·When to audit and types of audit

·Overview of FDA’s NIPP

·Defining scope and process for a GMP audit

·Best ways to evaluate the impact of the audit findings

·What does FDA expect from a sponsor regarding GMP compliance

·Pros and cons of working with internal and contract manufacturers, local and foreign GMP sites

·Best practices for personnel interviews, verifying data, and compliance to regulations

Why should you attend:

This webinar, presented by a leading expert on GMP compliance, will discuss best practices for preparing for an FDA audit of a GMP site. Common questions such as the best way to prepare the site team, documentation review, quality systems verification, SOP review, ways to verify QC and QA data collection and assuring accuracy, best way to view and analyze the product specific data, electronic and paper record review, and many more will be discussed. The seminar will discuss critical areas to focus resources, important things to verify, best practices to maintain cordial relations while scrutinizing and checking bad behavior, using audits to increase visibility and built better relations, troubleshooting without shooting the messenger, and many other practical insights. The webinar will provide precise and complete list of measures and checklists to help you evaluate your GMP sites. The presenter will use case studies from his vast experience to highlight common errors and potential solutions. Your GMP site will define if you get timely market approval; it is imperative you make sure it is always ready for an FDA audit.

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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Kelly Thomas, Vice President, Americas Quality Operations

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

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