ICH Q11- API Manufacturing - 2017
WebcastFaculty
OVERVIEW
ICH Q11- API Manufacturing is organized by Compliance4All and would be held on Jun 22, 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.
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.
SPECIALITIES
Quality ManagementQuick Links