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ICH Q11- API Manufacturing - 2017

Start Date:
Thursday, 22 June, 2017
End Date:
Thursday, 22 June, 2017 11:30am
Health & Nutrition

Overview: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 Process controls Selection of starting materials Control strategy Process validation evaluation Submission of information Life cycle managementWho Will Benefit: Quality Assurance Quality Control (Chem and Micro) Process and Design Engineering Process Automation Manufacturing Operations Validation Utility OperationsSpeaker Profile: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.Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email:


161 Mission Falls Lane,
Suite 216

Organizer Details

Conference organized by Compliance4ALL

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.

161 Mission Falls Lane, Suite 216

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