Explore the circumstances that impact the quality, safety, and availability of drugs and gain new perspectives and discuss best practices on the evolving regulatory landscape, supply chain risks, quality culture, and challenges in manufacturing:
- Latest FDA inspection findings;
- Compliance/enforcement trends;
- Quality trending;
- Effective quality systems;
- Consent decree lessons learned.
A wonderful opportunity to share some of our experiences as professionals working in bio pharma and regulatory affairs.
Featured Speaker- Lance M. Souza, M.B.A, Compliance Officer, Division of Pharmaceutical Quality Operations IV, Office of Regulatory Affairs