Events

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 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:

• Laboratory Analysts
• Quality Assurance scientists
• QA/QC Analysts
• QA/QC Managers
• Auditors
• Inspectors
• Pharmaceutical development and manufacturing personnel
• Manufacturers of raw materials and excipients
• Contract laboratory Organization personnel

Speaker Profile: