This CAPA and Risk Management Webinar/training will discuss the multi-level CAPA process and how regulatory standards requirement for CAPA relates to risk management.
Why Should You Attend:
CAPA findings in FDA inspections continue to be among the highest observations cited by investigators. FDA has provided information explaining that risk is an important consideration in the CAPA process. They do not however, provide any guidance on how risk is included in this important process. Additionally, more information is flowing out of FDA indicating that risk is becoming an additional focus of the agency, such as in the recent report on risk communication. Manufacturers need to understand what FDA expects in incorporating risk in the CAPA process, what strategies can be used to assign resources to CAPA activities, and how to manage multi-level CAPA processes, so that they will not run afoul of the FDA during inspections.
This presentation will examine regulatory and standards requirements of CAPA processes as they relate to risk management. We will discuss multi-level CAPA processes, and assigning resources to CAPA investigations, and corrective and preventive actions. During the presentation we will also examine the requirements for CAPA effectiveness checks, as well as integrating risk management into recall decisions and health hazard evaluations.
Areas Covered in the seminar:
- CAPA requirements in 21 CFR 820 and ISO 13485 and how they relate to risk management.
- How to establish a multi-level CAPA process that meets requirements.
- Using risk management to assign CAPA resources and priorities.
- Updating risk management files with information from CAPA process.
- Risk Management and CAPA effectiveness checks.
- How risk management integrates with recall decisions and health hazard evaluations.
- Risk Management and Supplier Corrective Actions.
Who will benefit:
This webinar is appropriate for all personnel associated with the CAPA process. The program is not limited to those with direct operation of CAPA, but also includes all personnel that may be affected by CAPA activities.
- Quality Auditors
- Quality Engineers
- CAPA managers
- Supplier Quality
- Risk Managers
- Process Engineering
Instructor Profile:
Edwin L. Bills, During his 20 year career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions. Mr. Bills is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of Quality/ Organizational Improvement. He also holds a certificate as Regulatory Affairs Certified through the Regulatory Affairs Professionals Society, and a BS and Masters degree from the University of Cincinnati. Recently, Mr. Bills served as US Industry Co-chair of the Association for Advancement of Medical Instrumentation committee, QM/WG04, on application of risk management to medical devices and is a current member of this group.
Mr. Bills has presented at training courses for the American Association of Medical Instrumentation (AAMI) in the area of risk management and quality systems. Currently, Mr. Bills is the Principal Consultant at Bilanx Consulting LLC in the area of medical device quality, regulatory, product liability and risk management.
