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ICH Q11- API Manufacturing – 2017
June 22 @ 10:00 am - 11:30 am$150.00
This webinar will address approaches to developing and understanding the manufacturing process for a drug substance. The information obtained will enable completion of the drug substance information in Module 3 of a CTD application.
Why should you Attend:
This presentation is presented in practical language understandable by all technically educated or trained individuals, regardless of specialty.
Areas Covered in the Session:
Manufacturing process development
Selection of starting materials
Process validation evaluation
Submission of information
Life cycle management
Who Will Benefit:
Quality Control (Chem and Micro)
Process and Design Engineering
Peggy J. Berry , MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics.
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