Cost Effective and Convenient - in your office or conference room

FDA Inspections: What to Expect
Learning from Other People's Experiences

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

July 16, 2010

This web 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 drug 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 drug establishment. The so-called risk based inspection is designed to optimize resource utilization for regulators.

In this seminar we 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.

We will review the various types of GMP inspections and who from the agency will be present. We will then review the criteria the FDA uses to define their inspection target, the frequency of inspection and the timing of such inspections. The seminar will then focus on the “System-Based Inspections” normally conducted by the FDA. In order to understand the system-based inspections we will first define what the FDA will look for in each system, review many examples of FDA 483 observations, relate them to the various systems and finally emphasize the issues of most concern to the regulators.

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
• Questions and answers 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.

Register now!

Don’t like to order online? Call us at 714-289-1233

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.

We accept Visa, MasterCard, and American Express (AMEX). All prices are in US dollars.

Note: Our shopping cart is set to the highest security level. Please make sure that the address corresponds to the credit card holder. It may result in a declined order if the address doesn't match the address on file for the cardholder named on the credit card.

Please enter your billing information EXACTLY as it appears on your credit card statement.

Get the MP3 file and handout GMP100709E - MP3 audio file and Handout materials FDA Inspections: What to Expect	$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.

Please forward this to your colleagues who may be interested.