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Validation of HVAC Systems (Heating, Ventilation and Air Conditioning): Doing it Right!
Conducted by Gamal Amer, Ph.D.
Principal - Premier Compliance Services, Inc.
May 30, 2014
Heating Ventilation Air Conditioning (HVAC) systems represent one of the most critical utilities in the pharmaceutical industry. These systems are the key to cleaning and conditioning the air used in the manufacturing facilities for drug products. They also play a key role in preventing microbial as well as cross contamination of the drugs during manufacture. This seminar will discuss the characteristics of the HVAC system and how to ensure the system is properly validated. The discussion will focus on applying the principles outlined in the latest FDA guidance on Process Validation issued in Janaury 2011.
We will address the activities which should take place during the design and development of the HVAC system for the pharmaceutical manufacturing operation as the first step in validating the system. Then we will address the appropriate activities which should take place during the implementation and qualification stage. The discussion will consider verification activities as well as Performance Qualification (PQ) and how to develop the appropriate protocols, design the correct tests, and define the proper acceptance criteria to ensure the system is qualified.
We will then consider the protocol execution phase and how to ensure that the system is fit for the intended use. Finally, we will review the appropriate activities to continually verify and ensure the system remains in a validated state through conducting environmental monitoring and applying change control.
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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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GMP140530E - MP3 audio file and Handout materials
Validation of HVAC Systems
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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