WCS Consulting Inc.3190 Stirling Rd, Unit K4, Hollywood, FL 33021,

Hollywood,

Florida,

United States,

ZIP: 33021

Phone: 347 282-5400

Live Webinar ICH Q11- API Manufacturing

November 01, 2020 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute
 

Description

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. The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. Both traditional and enhanced approaches are discussed.
 

Areas Covered

• 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

• Regulatory Affairs

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. Prior to founding Synergy Consulting in 2020

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. Prior to founding Synergy Consulting in 2015