Using a reliable process to meet current quality standards to determine the verifiable causes of problems.
The Quality Systems Regulation (21 CFR 820) and the Quality Management Standard for Medical Devices (ISO 13485:2003), require medical device companies to establish and maintain procedures for implementing corrective and preventive action (CAPA) as an integral part of the quality system. The CAPA system to identify problems may be initiated by any non-conforming event, trend, or finding, internal or external, relating to: materials, systems, components, finished devices, software, labeling, packaging, documentation, processes, tests, inspections, training, equipment, environment, maintenance, calibration, suppliers, distribution, design control or management review. A functional CAPA system is supported by robust root cause analysis.
Areas Covered in the seminar:
- Regulatory requirements for managing non-conformances.
- Recognizing and documenting non-conformances.
- Selecting specific problems for root cause analysis.
- Roles and responsibilities for conducting root cause analysis.
- Root cause analysis method.
- Implementing solutions based on identification of root causes.
- Management support for root cause analysis.
Who Will Benefit:
- 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 critical technical and business information on the effective commercialization and maintenance of products and services. Ron has been an active contributor to the industry for over 38 years and has developed commercially successful screening and diagnostic products for gastroenterology, infectious disease and point-of-care testing. Ron is a principal advisor for the Larta Institute which is supported by the NIH, Commercialization Assistance Program (CAP), for companies awarded SBIR and STTR 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. Schoengold earned his bachelor
