Event Overview:

This Web Seminar CD will present a general overview of the cleaning process for equipment and facilities in the pharmaceutical industry. The regulatory requirements for a cleaning SOP will be defined by reviewing several examples of FDA 483 notices of adverse findings given to companies in the industry. Once the regulatory requirements are defined, we will outline the structure of a general cleaning SOP and provide examples of the information it should contain. Once we establish the contents of a cleaning SOP, we will discuss the issues associated with cleaning validation. We will discuss preparing the cleaning validation protocol. Important aspects such as how to set acceptance criteria and how to measure cleanliness will then be reviewed. Finally we will touch on issues such as analytical methods used in cleaning validation, manual versus automated cleaning, and revalidation.

You will learn:

• What are the cleaning regulatory requirements
• How to prepare a cleaning procedure
• When to clean and how long it would remain clean
• The contents of a cleaning validation protocol
• How to define cleaning acceptance criteria
• What are he various sampling methods
• Where to sample for residual during the validation effort
• What are the appropriate analytical methods
• How to look for and identify potential problems

Our Expert Presenter

Gamal Amer, Ph. D.
Principal

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 25 years of 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.