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FDA Inspections: What to Expect
and How to Prepare
Conducted by Gamal Amer, Ph.D.
Principal - Premier Compliance Services, Inc.
June 6, 2014
This seminar will address the FDA process of risk-based inspection, types of inspections, and the system based inspection. If you manufacture, process, package or hold any FDA regulated products you WILL be inspected by the FDA. There are many types of inspections and as a manufacturer you should be familiar with them and be well prepared for them. The FDA has defined risk criteria based on which they would decide on the timing and frequency of inspecting a manufacturing establishment.
This seminar will review the overall criteria the FDA uses to decide on the location, timing and frequency of inspections. We will also review the systems that will be inspected and look at many recent FDA 483 observations to identify what happens during the inspection and what the FDA focuses on.
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 ensure that you are in compliance and ready for such inspections at all times.
This seminar 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 to be covered include:
- Why would the FDA inspect (Risk-Based Inspection)
- Who would be the inspector
- Which systems will the FDA inspect
- What the FDA looks for
- How to prepare for FDA inspections
- What is risk-based compliance and how to apply it to your situation
- What you can do to avoid further regulatory actions
- Questions and answers with Dr. Gamal Amer
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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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GMP140606E - MP3 audio file and Handout materials
FDA Inspections: What to Expect and How to Prepare
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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