How FDA trains its Investigators to Review CAPA and How should you prepare

The most common finding during any FDA inspection deals with issues that impact, are the result of, or are centered in the organization’s CAPA system.  Invariably, FDA inspectors will spend a great deal of their time when visiting your facility sorting through your CAPA documents, in detail.  It is imperative to understand what FDA inspectors specifically look for when reviewing your CAPA system so that measures may be taken to establish a compliant ongoing CAPA system that that will withstand FDA scrutiny.  It is also a goal of this webinar to provide you with the information that you can use to evaluate your own CAPA process as an investigator would.

Why You Should Attend:

This webinar will view the CAPA process from the FDA’s perspective using their own investigative manuals that FDA inspectors must follow when conducting inspections.  The relevant CAPA sections of the FDA’s Operations Manual, Compliance Program Guidance Manual 7382.845 and the QSIT Manual – Quality System Inspection Technique Manual will be discussed.

Foundationally, CAPA will be defined with its’s unique process steps explained in some detail.  Finally, before delving into the specific FDA manual content, the basic challenges and pitfall of the CAPA process will be reviewed.

Areas Covered in the Session :

• CAPA defined
• CAPA process steps explained
• Challenges and pitfalls of CAPA’s
• Documents Used by FDA Inspectors
• Operations Manual (IOM)
  • Problem identification and corrective action
  • Requirements
  • Recommended Methods of Compliance for Each Requirement
• Compliance Program Guidance Manual 7382.845
  • CAPA considerations relative to the inspection process
• QSIT Manual – Quality System Inspection Technique
  • Inspectional Objectives
  • Decision Flow Chart
  • Medical Device Reporting
  • Corrections & Removals
  • Medical Device Tracking

Who Should Attend:

• Quality Assurance Departments
• Quality Control Departments
• Regulatory Affairs Departments
• Manufacturing Departments
• Production Departments
• Executive Management
• Quality System Auditors
• CAPA coordinators
• Everyone involved in the manufacturer of pharmaceutical products, foods, beverages, cosmetics, medical devices that have some exposure to or responsibility for the CAPA system’s maintenance and execution

Course Director: Charles Paul

Charles Paul is an instructional designer and management consultant with over 30 years’ experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product – OTC industries.