Continuing Education Credits and Certificate Program units are not available for Archived Webinars.
Discuss Ongoing Initiatives Impacting Active Pharmaceutical ingredients (APIs)
Join this interactive webinar to hear expert perspectives on ICH Q11Development and Manufacture of Drug Substances as well as the Mock S2 Project European Federation of Pharmaceutical Industries and
Associations (EFPIA). The scope of this webinar is Chemicals (Small Molecules).
This webinar has been developed by the
Regulatory Affairs SIAC - CMC Working Group
This archived webinar is available through June 13, 2013.
Focusing on APIs:
- Critical Quality Attributes (CQA), Critical Process Parameters, and Control Strategy
- Science and Risk based approach to Process Development
- Design Space
- Post-approvals Change Management Protocols
- Selection of Starting Materials
- CTD Section 3.2.S.2
Who Should Attend
Professionals involved in:
- Quality Compliance/Quality Assurance
- API Development and Manufacturing
- Regulatory Affairs
- CMC Life Cycle Management
- CMC Project Management
At the conclusion of this webinar, participants should be able to:
- Explain the latest updates in the API arena
- Describe key points from ICH Q11 and EFPIA Mock S2
Click here for minimum system requirements.