Key Factors to Develop an Effective CAPA System

This training will focus on the regulatory requirements for a Corrective and Preventive Actions (CAPA) system. Attendees will learn how to develop an effective CAPA system.

Why Should you Attend:

A significant number of FDA 483 observations and Warning Letters cite CAPA deficiencies, thus FDA and regulatory agencies are looking closely at how pharmaceutical companies conduct their investigations, address their deviations and correct their activities. CAPA is the central component of Quality Management Systems and having an effective CAPA documentation and tracking system are crucial to pharmaceutical operations. This system will allow personnel to identifying the root cause, corrective action taken, and verification stages.

This webinar will cover regulatory requirements for a CAPA system, discuss important components to create an effective CAPA system, determine different levels of actions to be taken, and training needed to prevent reoccurrence.

Areas Covered in the Webinar:

• Why an effective CAPA system is important?
• Roles and responsibilities of manufacturers
• Identifying sources of infractions
• Determining root causes
• CAPA tracking system and documentation

Who Will Benefit:

• Laboratory Analysts
• Quality Assurance Scientist
• QA/QC Analysts
• QA/QC Managers
• Auditors
• Inspectors
• Pharmaceutical Development and Manufacturing Personnel
• Manufacturers of Raw Materials and Excipients
• Contract Laboratory Organization Personnel

Instructor Profile:

Kim Huynh-Ba, has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She currently is the Executive Director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree on harmonization and optimization of analytical best practices since 2003. Prior to Pharmalytik, she was the Director of Pharmacopeial Education Department of U.S. Pharmacopeia (USP), where she was responsible for their education programs worldwide. Kim is also a short course instructor on cGMP compliance and quality topics for several global organizations such as ACS, AAPS, Pittsburgh Conference, and many other international training groups. She is an Adjunct Professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology (IIT) teaching pharmaceutical analysis and analytical chemistry graduate courses.