Year after year, CAPA is the subsystem cited most frequently during FDA inspections. A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer. A system that identifies and eliminates nonconformances and potential nonconformances enables both regulatory compliance and cost savings. This session will begin by reviewing the regulations associated with CAPA, paying close attention to those that are the most difficult with which to comply. The session will also discuss the importance, requirements, and elements of a CAPA program, as well as describing the sources and uses of CAPA data. The application of risk management to a CAPA program will be reviewed, and a specific risk management system detailed. The session will also cover root cause analysis, and various tools used in its discovery. A fully functioning CAPA program must, at its core, be driven by accurate and timely root cause analysis. A tried and true method for assuring timeliness of root cause will be covered. Real-life hypothetical situations will be evaluated to assure comprehension.

Course Objective:

During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? The last part of this session will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with. Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, and how your company can use that same document in your preparation. This session will cover all the items listed above, and more. If you want to improve your CAPA system, you cannot afford to miss this.

Course Outline:

• Definitions
• Where/When is CAPA Required
• Elements of a Corrective Action Program

o Essential SOPs and Other Documentation
o Detection of nonconformance
o Identification of cause (Investigation)
o Review of Investigation
o Determination of Corrective/Preventive Action
o Performance of Corrective Action
o Implementation of Corrective Action
o Effectiveness of Corrective Action
o A Tool for Timeliness

• Common Misconceptions
• Root Cause Analysis
• Fun and Games with CAPA: A Mini-Workshop
• Sources of, and Application of, CAPA
• How FDA Trains its Investigators to Review CAPA, and Recommended Compliance Methods

What You Get:

•  Training Reference Materials
•  Live Q&A with our Expert
•  Participation Certificate
•  Access to Signup Community (Optional)
•  Reward Points

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies, since a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.

The employees who will benefit include:

• CAPA Coordinators • Executive Management • R&D Management • Regulatory management • QA management • Consultants • Quality system auditors