Dr Gerhard Bauer-Lewerenz, Bauer-Lewerenz Consulting, Bad Homburg, Germany
For years, inadequate CAPA measures have been at the top of the FDA Warning Letter hit list for medical devices. This goes hand in hand with an equally often inadequate complaints management. CAPA deficiencies not only result in system deficiencies, but also in the frequent failure to recognise the recurrence of an error. Here, appropriate monitoring with a trend analysis fails. In particular, the Warning Letters repeatedly mention deficiencies in the documentation and verification of CAPA measures.
CAPA deficiencies are a mandatory part of the management review, so that senior management can react accordingly.
CAPA and Management Reviews have been requirements of the corresponding ISO standards (especially ISO 13485:2016) and 21 CFR 820 for years, MDR also requires both, but the requirements are very general. A guideline of the Global Harmonisation Task Force (GHTF) from 2010 also provides further assistance. However, how is CAPA management implemented in the medical device industry today so that all requirements of the regulations are met? How is a trend integrated into CAPA management and how are deficiencies correctly addressed in management reviews? These are questions that will be clarified in the webinar. Furthermore, exemplary CAPA deficiencies will be presented
Employees from companies, who are involved in CAPA Management, trending and management review (QM, manufacturing, quality control, etc.) are addressed. Of course, consultants in this field, who want to get information from the view of the medical device industry, are also addressed.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
The following issues will be discussed:
- Oversight regulations: ISO 13485, GHTF Guideline CAPA, MDR, 21 CFR 820.100/198
- A more efficient CAPA System
- Interface complaint management
- Radicial Root Cause Analyse: e. g. „Five times why?”
- Clear verification and validation of measures
- Monitoring and trending - a CAPA subsystem
- The managemen -review – CAPA´s final stage?
- Examples of FDA Warning Letter findings