Web seminar - Fundamentals of Cleaning and Cleaning Validation
Fundamentals of Cleaning and Cleaning Validation
Conducted by Gamal Amer, Ph.D.
Principal - Premier Compliance Services, Inc.
Feb 12, 2009
11:00 am EST, 10:00 am CST,
9:00 am MST, 8:00 am PST
The seminar will run for one hour.
Click here to check your time
(Note: Washington DC and New York are in the EST)
This web seminar presents 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.
Specific issues associated with cleaning validation will be discussed, and how to prepare the cleaning validation protocol. Important aspects such as how to set acceptance criteria and how to measure cleanliness will be reviewed. Finally we will touch on issues such as analytical methods used in cleaning validation, manual versus automated cleaning, and revalidation.
By attending this web seminar 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
This seminar will be conducted on the telephone and is presented by Gamal Amer, Ph.D., 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. Dr. Amer's qualifications can be found below.
Register now!
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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 web location to download the handout materials.
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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.
