In this webinar we will discuss the regulatory expectations that apply to the production and control of active pharmaceutical ingredients. The discussion will start with the introduction of ICH Q7, the internationally accepted GMP for APIs, and discuss how this is supplemented by contemporary guidance such as ICH Q10, the Pharmaceutical Quality System, ICH Q8, Pharmaceutical Development, ICH Q9 Quality Risk Management and ICH Q11, Development and Manufacture of Drug Substances. The impact of new FDA guidance on Process Validation and Quality Metrics will also be considered.

The following areas will be included:

• Drug GMPs
• ICH Q7
• ICH Q8
• ICH Q9
• ICH Q10
• ICH Q11
• FDA Process Validation guidance
• Data Integrity
• Quality Metrics

1. In the API manufacturer
   1. Senior management
   2. Site managers
   3. Materials
   4. Production
   5. Quality Control
   6. Quality Assurance
      1. Reviewer
      2. Auditor
2. In the Drug Product  Manufacturer
   1. Purchasing agents
   2. Quality Assurance
   3. Quality Control
   4. Quality auditor

John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where he has managed Analytical Research, Quality Control and Quality Assurance functions.

In 1994 Dr. Lanese formed his own company, The Lanese Group, and since that time he has been a consultant in the area of quality system and cGMP compliance and has audited and consulted with small and large medical device and pharmaceutical companies, including companies under FDA Consent Decree, API and excipient manufacturers, electronic firms and other manufacturing organizations.