Cost Effective and Convenient - in your office or conference room
Effective Equipment Design for Cleaning and Cleaning Validation
Conducted by Gamal Amer, Ph.D.
Principal - Premier Compliance Services, Inc.
August 28, 2015
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11:00 am EDT, 10:00 am CDT,
9:00 am MDT, 8:00 am PDT
The seminar will run for one hour.
Click here to check your time
(Note: Washington DC and New York are in the EDT)
This seminar will review the life cycle approach to cleaning and cleaning validation. This will identify that proper design of the equipment is the first step in this approach. Proper design of equipment to ensure clean-ability is of critical importance to ensure that drugs are not eventually contaminated. We will review the types of equipment one may encounter and their impact on the design process.
We will then discuss the factors one must consider when designing a piece of equipment from a cleaning and cleaning validation point of view. A review of the general design consideration for equipment will then ensue. Finally, we will discuss the documentation requirements as well as pre-installation and -validation testing to be conducted.
By attending this webinar you will learn:
- What is meant by the life cycle approach to cleaning and cleaning validation
- The need to carefully design equipment with their eventual proper cleaning in mind
- What are the issues the issues one must consider when designing a cleanable piece of equipment
- The type of documentation one must develop and have on hand to meet GMP compliance requirements as it relates to cleaning
- Initial testing for clean-ability
This seminar will be conducted using GotoMeeting.com 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.
The log-in information and a handout presentation file (to use as a backup) will be sent to you via email the day before the seminar.
Don’t like to order online? Call us at 714-289-1233
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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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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