$150.00

ICH Q11- API Manufacturing – 2017

ICH Q11- API Manufacturing

Description

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: support@compliance4All.com

Ad Reference ID: 78158f8914326e3e

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