Tuesday 9th April, 2013
10:00am to 11:00am
Overview: 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 session will discuss important components to create an effective CAPA system, determine different levels of actions to be taken, and training needed to prevent reoccurrence.
Why Should You Attend: FDA and regulatory agencies are looking closely in how pharmaceutical companies conduct their investigations, and CAPA is viewed as the central component of Quality Management Systems. However, a significant number of FDA_483 observations and Warning Letters cite CAPA deficiencies. This session will also cover regulatory requirement for a CAPA system.
Areas Covered in the Session:
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:
Quality Assurance scientists
Pharmaceutical development and manufacturing personnel
Manufacturers of raw materials and excipients
Contract laboratory Organization personnel
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.
Livermore Common, Fremont, CA, 94539
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9th April 2013