ICH Q11- API Manufacturing - 2017

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 management

Who Will Benefit:

•     Quality Assurance
•     Quality Control (Chem and Micro)
•     Process and Design Engineering
•     Process Automation
•     Manufacturing Operations
•     Validation
•     Utility Operations

Speaker 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: +1-800-447-9407
Email: [email protected]

Others Details

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