2017 - 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: support-AT-compliance4All.com