Live Webinar ICH Q11- API Manufacturing
01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute
Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar
"Hear By Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting "
Q11 guidance and learn skills for practical implementation of those requirements.
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.
Why You should Attend The Session
This presentation is presented in practical language understandable by all technically educated or trained individuals, regardless of specialty. This information would be useful at levels from senior management to operative, and would be valuable for experience levels ranging from seasoned veterans to those newly assigned to roles related to manufacturing. By the end of this program, attendees will understand the requirements of the Q11 guidance and learn skills for practical implementation of those requirements.
- 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
• Utility Operations
• Regulatory Affairs
Industries who can attend
This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.