The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appropriate elements of process validation for the manufacture of human and animal drugs and biological products, including Active Pharmaceutical Ingredients (APIs).
Why should you attend:
The Process Validation Guidance for Industry was recently revised after many years. With the emphasis today on being able to assure that a process is meeting its requirements through Validation, and not simply through Verification or Qualification, an understanding of both its importance and how to accomplish this feat has come to the fore.
Who will benefit:
Barry A Friedman
Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena
Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance, Microbiology and Aseptic Processing arena. From 2000 to 2007, Dr. Friedman was associated with Cambrex Bio Science Baltimore, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, MD.
Location: Los Angeles, CA Date: July 28th & 29th, 2016 and Time: 9:00 AM to 6:00 PM
Venue: WILL BE ANNOUNCED SOON
Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
Until June 10, Early Bird Price: $1,295.00 from June 11 to July 26, Regular Price: $1,495.00
NetZealous DBA as GlobalCompliancePanel
Registration Link - http://bit.ly/Process-Validation-Guidance
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