Cost Effective and Convenient - in your office or conference room

Proven Steps to Reducing Waste
in Process Validation

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

March 19, 2010

This seminar will provide you with proven steps that result in streamlining Process Validation and reducing waste when validating a pharmaceutical manufacturing process.

Process Validation is a regulatory requirement and an important component of GMP compliance within the healthcare industry. The FDA has issued a proposed Guidance just 15 months ago titled “Process Validation: General Principles and Practice,” which defines a life cycle approach to validation consisting of three distinct stages. Waste in the effort can occur anywhere within it and the challenge is to recognize it as a first step towards mitigating it.

This seminar will review the types of waste one may encounter during the process validation effort as well as some of the reasons which may cause it. We will discuss all the relevant guidance and standards which may be invoked to mitigate waste and assist in streamlining the validation activities. Once we understand the principles, we will review each of the three stages of Process Validation and identify some of the causes of waste of resources during implementation of that stage’s activities and ways to reduce or eliminate the waste.  
 
By attending this web seminar you will learn:

• What Process Validation entails based on the new proposed FDA guidance
• Why is process validation important and how it is normally conducted
• The role of ICH guidance in defining the way Process Validation maybe conducted
• Where the waste in conducting Process Validation occurs
• How the waste manifests itself and how to mitigate it
• What a systematic approach to Process Validation may look like.
• A 10 step process for eliminating waste and streamlining your validation processes

In this unique web seminar format conducted on the telephone, lasting just one hour, you will be able to follow along with a handout presentation file, ask questions, and interact with Dr. Amer. An outline of this seminar and Dr. Amer's qualifications can be found below. The handout presentation file will be sent to you via email the day before the seminar.

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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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Get the MP3 file and handout GMP100319E - MP3 audio file and Handout materials Proven Steps to Reducing Waste in Process Validation	$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.

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