In 2019, FDA issued the first Warning Letter for violations of the Drug Supply Chain Security Act, signaling its heightened attention to supply chain and distribution issues. Since DSCSA was enacted in 2013, various provision have come into effect. It is important for companies not just to understand the law’s requirements, but also how to integrate DSCSA compliance broadly in areas such as product quality and pharmacovigilance. With increased regulatory scrutiny, all members of the supply chain should know what to watch out for in their operations.
During this webinar, co-hosted with Lachman Consultant Services, we will discuss:
- The basics of the Drug Supply Chain Security Act regulations and guidances, including future requirements
- The applicability to drug manufacturers, wholesalers and third-party logistics providers and the differences in responsibilities
- Gaps commonly seen in implementation
- Recent FDA enforcement actions and considerations for
future enforcement
Speakers
Howard Sklamberg, Arnold & Porter, Life Sciences & Healthcare Regulatory
Abraham Gitterman, Arnold & Porter, Life Sciences & Healthcare Regulatory
Ricki A. Chase, MS, Lachman Consultant Services
