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FDA Inspections: How to Prepare
Learning from Other People's Experiences

Conducted by Gamal Amer, Ph.D.
Principal - Premier Compliance Services, Inc.

July 23, 2010

It is incumbent on the healthcare product manufacturer to always be in compliance with GMP requirements and be prepared for regulatory inspections. This seminar will define several steps to be taken by the manufacturer to prepare for FDA inspections.We will review in broad terms how to insure that you are in compliance and ready for such inspections at all times.

Not only do you need to anticipate what the FDA will be looking for, but you also need to utilize the resources available to you to ensure that you are in full compliance with the law. This will lead us into a discussion of risk-based compliance. Armed with the fundamental principle of protecting the public and minimizing danger to the patients, we will discuss how to apply risk assessment to improve your compliance quotient.

Next we will define what you should do and how you should act during the inspection in order to assist the regulator with the inspection and minimize any future deleterious effect. We will also review what you should do once the inspection is over in order to address the regulator’s concern and avoid further regulatory actions such as warning letters, consent decrees, product seizure, closure of operation, and or criminal charges.

Specific topics covered include:

• How to prepare for FDA inspections
• What is risk-based compliance and how to apply it to your situation
• What you could do to avoid further regulatory actions
• Questions and answer with Dr. Gamal Amer

In this unique web seminar format, lasting just one hour, you will be able to follow along with a PowerPoint presentation, ask questions, and interact with Dr. Amer. An outline of this seminar and Dr. Amer’s qualifications can be found below.

The handout presentation file will be sent to you via email the day before the seminar.

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All registrations include handout materials. Once you’re registered, you will receive via e-mail (the e-mail address you provide in your registration) the presentation handout materials the day before the seminar.

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Get the MP3 file and handout GMP100716E - MP3 audio file and Handout materials FDA Inspections: How to Prepare	$397.00

Instructor

Gamal Amer, Ph.D.
Gamal Amer, Ph. D. is Principal at Premier Compliance Services, Inc.; Management Consultants for compliance and manufacturing operations performance in the life sciences industry. He holds a Ph. D. in Chemical Engineering and has over two decades experience in the Pharmaceutical and related industries. He has held positions of increased responsibility with leading pharmaceutical, consumer product and engineering consulting firms over the years. His experience includes comprehensive process design in bulk pharmaceutical manufacturing, biotechnology manufacturing, pharmaceutical solid dosage manufacturing and containment of potent and radioactive therapeutics. He is also experienced with facility development for therapeutic products operations.

Dr. Amer is a recognized expert in GMP compliance and validation. He has consulted for many of the leading pharmaceutical, biotechnology and medical device manufacturers. He has lectured extensively in the US, Europe, Asia and the Middle East, taught many courses, and authored many papers which were published in peer reviewed publication. He is a member of ISPE, PDA, ACS and AIChE.

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