FDA is Changing CMP Audit Practices: Are You Ready?

Date: January 27, 2025
Duration: 60 Minutes
Time: 12 PM EST

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.

Who will benefit:

Project managers
Manufacturing and supply chain operations
Regulatory affairs personnel
Quality assurance personnel
Vice presidents, Directors and Managers
People interested in investing in the FDA-regulated industry

Speaker: Mukesh Kumar

PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.

Webinar Fee

Single Registration

$199

Group Registration (5 Persons)

$699

Group Registration (10 Persons)

$1199

Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.

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Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com

Payment

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Cancellations & Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.

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