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Practical Two Day FDA Inspection Online Seminar – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “FDA Inspection” training has been added to ResearchAndMarkets.com’s offering.


This is a practical, hands-on two-day seminar designed to provide pharmaceutical, biopharmaceutical, biologics and medical device professionals with the information and tools they require to prepare for and manage an FDA inspection efficiently, effectively, and successfully. Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions.

Non-compliance is an expense that no healthcare company can afford. Companies must establish proven and sustainable GxP compliance strategies and risk mitigation strategies when responding to a crisis so you avoid costly product approval delays, recalls and adverse impacts on shareholder value, including FDA enforcement actions.

Companies must adopt a risk-based approach to managing quality and regulatory compliance not only for GCP, GLP and GMP but across the entire platform. Whatever solution you are using it needs to provide a common framework and an integrated approach to meet FDA GxP regulations through effective risk management, document control, compliance training, ongoing auditing, surveillance and monitoring activities and other critical areas that will be addressed during the seminar.

This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do’s and don’ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483s and Warning Letters.

The course will go through what typically goes on during an FDA Inspection and will then cover how to prepare for, host and follow up to a regulatory inspection. It will emphasize and focus on the critical and vital elements that you should do or not do during the inspection. Typically, FDA inspections can be highly structured and there are procedures that are to be followed as you prepare for state of readiness. It is important for anyone who might be involved in the inspection to be aware of these procedures, including all employees and personnel to ensure there are no surprises.

The course will also provide information for inspections conducted by international agencies as well as non-FDA agencies, including self-inspections for manufacturing and the famous FDA Mock Inspection or Mock Audit. It will explain how to prepare for an inspection, how to handle a scheduled or non-scheduled inspection, what to expect during an inspection, and what follow-up to expect after an inspection.

Why Should You Attend?

12.0 RAC CREDITS

RAPS – This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Who Should Attend:

This seminar will provide an overview and in-depth snapshot of the entire process for preparing for and managing and FDA inspection and external regulatory inspections and for those companies who must establish proven and sustainable GxP compliance strategies and risk mitigation strategies when responding to a crisis.

Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a “refresh” overview of the FDA inspection process from preparing for the inspections, during the inspections and post-inspection responsibilities and follow up activities with FDA, including:

For more information about this training visit https://www.researchandmarkets.com/r/ltaeub

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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