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An Introduction to Process Validation - For Beginners

 
  June 05, 2012  
     
 
ComplianceOnline, Online Event
2012-06-20


Why Should You Attend:

With new manufacturing technologies increasingly becoming a larger part of our pharmaceutical product supply, validation is gaining in importance to pharmaceutical manufacturers. Whether a firm performs its own validation, hires a validation contractor or delegates the responsibility to a third party contract manufacturer, the ultimate responsibility always falls to the firm whose name appears on the label. The only way that this can be done with confidence is to have an adequate number of validation experts on staff. Since many firms believe that they no longer need an in-house validation staff, they have done away with this overhead cost. Now it is essential to have a minimal on-site validation presence. Since there are very few validation experts today. It is often necessary to train people in this lost art.

This webinar will cover the basics of validation. This 60-minute session will expose beginners to the basics of the process and give them a strong understanding of what is involved.

Areas Covered in the Seminar:

  • What is validation and why is it important
  • Validation master plan
  • Validation protocols
  • IQ
  • OQ
  • PQ
  • Summary Report
  • Types of validation
 
 
Organized by: ComplianceOnline
Invited Speakers: James R Harris, PhD has over thirty years of pharmaceutical industry experience in R&D, manufacturing, quality, GMP compliance, validation, and management. He wrote the first FDA approved validation guideline for computerized systems. Following his industry career, Dr. Harris formed a consulting firm with sixty expert consultants who worked with firms around the globe. He has been a frequent speaker at industry meetings around the world and has had papers published in many industry publications and several languages.
 
Deadline for Abstracts: 2012-06-20
 
Registration:
For Registration:
 
E-mail: referral@complianceonline.com
 
   
 
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