How To Conduct a Successful Process Validation

Duration: 60 Minutes
This presentation covers a methodology that can be used for any oral product process validation. Full Process Validation consists of three parts:
Process Validation
Instructor: Dr. James R Harris
Product ID: 500047

  • Validation of process equipment installation
  • Validation of process equipment operation as per vendor specifications
  • Actual validation of the process itself.
A successful Process validation program depends upon knowledge from product and process development. This is the basis for setting up an approach to control of the development process that result in products with the desired quality attributes. Manufacturers must understand the sources of variation, detect the presence and amount of variation, realize the impact of variation on the process and ultimately on product attributes, control the variation in a manner proportionate with the risk it represents to the process and product.

Why Should you Attend:
Learn what to do and what not to do in order to accomplish a rapid and professional process validation.

Objectives of the Presentation:
To present validation methodology and build confidence that your validation is complete and professionally formed.

Who can Benefit:
  • Management and Supervision of Manufacturing
  • Quality Assurance
  • Quality Control
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Instructor Profile:
Dr. Harris has over 25 years of senior level pharmaceutical industry experience. Following this and for the past 15 years, he operated a global consulting firm that provided guidance to firms in over 60 countries around the world. During his tenure in the pharmaceutical industry, he was very active in industry groups. He served on the PMA's Validation Advisory Committee and was chairman of the Computerized Systems Advisory committee where he wrote the original guideline on computer validation and negotiated its acceptance with FDA. While consulting, he and his consulting teams have assisted numerous clients around the world with validation of their manufacturing processes. Dr. Harris played a vital role in establishing many of the regulations in existence today, with particular emphasis on validation of all types.
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