Introduction to CAPA Management

Laura Jeannel

Course description

There have been several form 483s and warning letters being issued to companies by the FDA as it relates to CAPA investigation because of insufficient or incomplete quality systems procedures applicable to Corrective Action and Preventative Action programs(CAPA).

Addressing an FDA form 483 with findings associated with CAPA systems must be performed adequately, and completely and provide enough details within the CAPA procedures to ensure an effective CAPA investigational procedure. All failures, deviations, or out-of-specification investigations must be adequately documented, corrected, prevented, and checked for corrective action effectiveness through the use of a compliant CAPA investigational system and program.

The result of a product investigation impacts the quality of the cGMP manufactured product label claim, to avoid it from being termed ‘adulterated” by the FDA which may result in product recalls, complaints, and further actions by the FDA.

In this introductory accredited training, we will discuss and highlight to GMP professionals the importance of writing effective CAPAs from initiation, implementation, closure, effectiveness, and follow-up. It will be a great resource for professionals to build and strengthen their CAPA Management program into a proactive and preventive system for Quality Management Systems. Additionally, key case examples will aid personnel in identifying the most effective means to continuously develop effective CAPAs for an enhanced and more robust program.

Upon completion of this course, you will be able to:

• Initiate, complete, and perform effective writing skills for CAPA Management
• Define key differences between Corrective Actions and Preventive Actions
• Identify key implementation in a targeted manner in a multi-tasking environment
• Show closing complete and robust CAPAs to prevent recurrence
• Define CAPA Effectiveness
• Evaluate Trend Management while building a proactive and preventive system as a key component to the Quality Management System

FROM THE ATTENDEES:
“Laura provided a wealth of knowledge, and her thorough industry experience really shined through with the presentation of information. Though it was a lot of content, she broke it up in a very digestible manner. The course definitely enhanced my understanding of CAPAs & the CAPA process, which will improve my ability to contribute to conversations and communicate effectively with industry experts.” – Life Sciences Recruiter at Vi-Leon

COURSE OUTLINE

Module 1:

• CAPA and Regulatory Requirements for Pharmaceuticals and Medical Device
• Correction and Preventive Actions and their meaning
• Writing Effective CAPA Plans and implementation

Module 2:

• CAPA Reviews and Closure
• CAPA Effectiveness and follow-up
• Trends and insights