ICH Q11- API Manufacturing - 2017
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 and Presenter Information
Peggy J. Berry , MBA, RAC
President & CEO, Synergy Consulting
Peggy 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.
Expected Number of Attendees
100Relevant Government Agencies
FDA, Manufacturing
Event Type
Webcast
This event has no exhibitor/sponsor opportunities
When
Thu, Jun 22, 2017, 10:00am - 11:30am
Cost
| General Admission: | $150.00 |
Website
Click here to visit event website
Organizer
NetZealous - Compliance4All
