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Environmental Monitoring: The True Reasons

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

June 19, 2009 

FDA expects pharmaceutical manufacturers to be in control of the environmental conditions within the manufacturing facility. Controlling the environmental condition is not only a regulatory requirement but also part of protecting and producing a quality product. This presentation will define what is meant by environment, what conditions are required and how such conditions may be dictated by the type of product being processed.

The presentation will then proceed to discuss how to obtain the desired environmental conditions, manage the conditions within the space, and what is required to ensure that the environmental conditions remain in a state of control. We will define standard environmental conditions to be maintained in manufacturing space based on published standards and compendial documents. A hypothetical biotech manufacturing facility will be used as an example to show the use of various conditions as they apply to various activities with the processing of a Biotech product.

The discussion will then describe various methods to monitor such conditions and where to monitor within the space. The frequency of the monitoring will be reviewed based on the criticality of the activity being performed in the space. We will emphasize how to collect the data and what to do with the data once collected. Trending, identifying alert and action levels will be defined and possible preventive and corrective actions will be reviewed.

Through out the presentation we will review actual FDA 483 observation as they relate to environmental monitoring to emphasize the issues of most concern to the regulators. We will allow some time for Q&A at the conclusion of the seminar.

This seminar will be conducted on the telephone and is presented by Gamal Amer, PhD, an industry expert on this and other compliance related topics.

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.

Environmental Monitoring: The True Reasons

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Get the MP3 file and handout GMP090626E - MP3 audio file and Handout materials Environmental Monitoring

$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.