GPhA: 2014 GPhA CMC Workshop
Tue, June 3, 8am – Wed, June 4, 5pm
Bethesda North Marriott Hotel and Conference Center: 5701 Marinello Road, North Bethesda, MD 20852
GPhA is pleased to announce the 2014 two-day CMC workshop devoted solely for the purpose of fostering in-depth discussion on the FDA’s CMC expectations for ANDAs, enhanced regulatory filing requirements as well as the new stability expectations for generic drug products.
Attend this interactive workshop and have the opportunity to learn the most up-to-date information regarding CMC regulatory quality requirements and how generic applicants can more effectively meet the challenge of first cycle approval.
- To discuss the FDA/OGD's new review process and filing expectations of Type II DMF for drug substance.
- Discuss key strategies for applicants to effective address quality expectations and work towards the goal of first cycle approval
- To detail the FDA/OGD's expectations for regulatory filing expectations for multiple batches and stability requirements for generic drug products.
- To describe the use of risk assessment, DOEs and other approaches in the determination of critical quality attributes, critical material attributes, and critical process parameters and their relationships.
- To discuss the FDA/OGD's progress in revising QbR questions to incorporate quality target product profile, product and process design and understanding, and control strategy.