Compliance is not passive! The regulatory agencies expect you to continuously evaluate and monitor your state of compliance, maintain compliance, and ensure sustained compliance. By understanding the interplay of regulations as the drug substance and drug product transition from lead compound through final commercialization, a drug development program can be optimized to prevent delays that can result in lost time, delayed return on investment and a shorter market life cycle.

This audio conference will provide an overview of the regulatory compliance requirements through the various phases of product development. The speaker will discuss the take-away message from current FDA compliance activities and present options to prevent, respond, and remediate compliance issues as necessary.

This audio conference covers:

• Regulatory compliance expectations and requirements for API and drug product development
• Compliance expectations, from pre-IND through commercial manufacture of APIs and drug products
• Considerations for selection of CROs and CMOs
• The cost of noncompliance

About the speaker:

Ruth Ann Lee, Ph.D., is Director and Executive Consultant, Scientific Consulting at Beckloff Associates, Inc. Since joining BAI in 2009 in the La Jolla, CA office, Dr. Lee has been involved in consulting associated with API and drug product development. She has performed CGMP audits and compliance training for non-clinical and CMC projects. Her current projects include maintenance of 17 US and Canadian DMFs for Pacific Rim customers and providing QC support to a fast track API development program for a Fortune 10 company.

Dr. Lee joined Allergan Pharmaceuticals as a Scientist in R&D physical chemistry immediately after obtaining her doctorate and later moved to QC where she was Manager of Compliance/QC chemistry and inspection. Before joining BAI she was Director of QA at NeoMPS, an international manufacturer of CGMP peptides for use as APIs. She holds a Doctorate in Analytical/Inorganic Chemistry from Georgetown University.

Who should attend?

• Product Development Specialists
• Regulatory Affairs & Compliance Specialists
• Quality Assurance & Quality Control Specialists
• API/Drug Product Manufacturing
• Outsourcing