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Effective Microbial Control in Pharmaceutical Manufacturing Operations: Preventing Contamination of Drug Products
Conducted by Gamal Amer, Ph.D.
Principal - Premier Compliance Services, Inc.
Microbial contamination of drug products, whether sterile or not, is objectionable. GMP regulations require drug manufacturers to control such contamination. Over the years, the pharmaceutical industry has developed many approaches to reduce or eliminate the potential microbial contamination of drug products.
This seminar will explore the reasons drug manufacturers have to control microbial contamination, the sources and pathways of microbial contamination, how to protect your product from microorganisms, identifying microbial contamination, and what to do when contamination occurs. We will also outline the role of environmental monitoring in controlling microbial contamination. The presentation will emphasis the points made using real life example FDA 483 citations.
In this seminar you will learn:
- Why control of microbial contamination in drug manufacturing is critical
- What are the types of organisms you may encounter
- How contamination occurs
- What precautions you should take to reduce contamination
- How to protect your product from microorganisms
- What to do if contamination occurs
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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
GMP120210E - MP3 audio file and Handout materials
Effective Microbial Control in Pharmaceutical Manufacturing Operations
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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