Developing a Robust CAPA System

In the event of an internal or external (e.g., FDA) inspection, all CAPA files should be easily accessible and readily retrievable. In this webinar instructor will explain what are essential elements of CAPA system to meet current regulatory requirement and how to achieve it.

The basic CAPA procedure should clearly define the fundamental elements for developing CAPA files which address significant quality system non-conformances (e.g., safety and product quality issues), including: a CAPA project summary, executive summary, chronology of events, objective evidence, immediate actions, root cause analysis methods, implementation of corrective and preventive actions, verification of corrective and preventive actions, effectiveness monitoring, CAPA file checklist and closure. The elements of the CAPA system must meet current regulatory requirements. The supporting file should follow a uniform format, including a numbering system, and contain appropriate content generally applicable to all CAPAs. CAPA files may be maintained as electronic or hard copy with all versions retained until the file is reviewed, completed (signed off) and officially closed. CAPA files should be maintained by the CAPA owner while in progress, and then stored for future reference in a permanent filing system.

A designated individual in the company should maintain overall responsibility for CAPA files, and know the status and location of each CAPA file. The current status of CAPAs should be reported at Management Review. CAPA files should be updated as new information becomes available; all information should be shown in the CAPA chronology. In the event of an internal or external (e.g., FDA) inspection, all CAPA files should be easily accessible and readily retrievable.

Areas Covered in the seminar:

• Outlining the requirements of the CAPA process and procedure including building a CAPA file.
• Establishing a CAPA plan: project definition, individual responsibilities and expected completion dates.
• Definition of the essential elements of the CAPA file and their intended purpose.
• Documenting root cause analysis in the CAPA file.
• Management oversight and monitoring CAPA activities.

Who Will Benefit:

• Senior Company Executives
• Quality Managers
• Regulatory Affairs Managers
• Program Managers
• Project Managers
• Product Development Managers
• Research and Development Managers

Instructor Profile:

Ron Schoengold, is a consultant to the biotechnology and medical device industry, offering quality solutions, and critical technical and business information on the commercialization and maintenance of products and services. He has been an active contributor to the industry for over 39 years and has developed commercially successful screening and diagnostic products for gastroenterology, infectious disease and point-of-care testing. Schoengold is a principal advisor and mentor for the Larta Institute which is supported by the National Institutes of Health (NIH), Commercialization Assistance Program (CAP), for companies awarded SBIR grants. Schoengold has published, presented or contributed to more than 16 scientific journal articles, co-authored a book chapter on point-of-care testing and holds 8 patents related to point-of-care diagnostics. He earned his bachelor’s degree in biology and chemistry, did his master’s training in microbiology and biochemistry and completed additional graduate studies in microbiology, genetics, molecular biology and immunology.

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