FDA GMP Requirements for API (Active Pharmaceutical Ingredients) - Just what do YOU need to do?

• OVERVIEW

While this topic may appear easily addressed, appearances can be deceiving. This program will examine some history, real life experiences and discuss the real facts about GMP for Active Pharmaceutical ingredients. Just what is important to firms, producers of API and consumers of API. Discussed will be what regulations apply and what guidance is important. Also examined are various ICH and FDA guidance that enter the everyday business of API manufacturing and use. Understanding what is examined during FDA inspections is important so that firms can manage and complete such inspections successfully. This Webinar will also examine where there exists flexibility in the application of GMP.

• WHY SHOULD YOU ATTEND

This program will prepare you by improving your understanding of what FDA examines during FDA's inspections and on-site visits. With this information, you will be better prepared to get through a successful FDA encounter. This is easy to read about but much more difficult to apply and prepare correctly for the real-world experience you will encounter during an FDA review!

• AREAS COVERED
• FDA Regulations and Guidance
• FD&C Act
• Producing API
• Where and how does GMP apply
• Historical Examination of Federal FDA Legislations
• USA and other country/world rules
• ICH Guides
• How GMP and other FDA Guidance's relate
• Systems examined by FDA
• API verses Drug Products
• FDA's Expectations
• Key element of producing API
• Purchasing API
• CMO of API

• WHO WILL BENEFIT?
• Quality Control
• Quality Assurance
• Regulatory Affairs
• Manufacturing
• Development
• Warehousing/Distribution
• Sales/Marketing