1 Hour and 30 Minute Video | Lonnie Lassmann, KCI
The FDA is heavily focused on enforcing Corrective and Preventive Action (CAPA) System requirements having recently cited numerous manufacturers for failure to maintain these practices. In today’s highly regulated environment, sufficient CAPA data and documentation processes that demonstrate product quality and safety are a top priority for quality teams; however, many continue to struggle with determining which issues should or should not be elevated to CAPA status. A recent industry study conducted by BSI reviewed FDA CAPA audits and found that quality departments often put too much emphasis on issues that don’t qualify for CAPA and ultimately struggle to focus on the “preventive” measures. In order to ensure product safety and effectiveness, it is critical for manufacturers to operate a CAPA system that will continuously monitor and improve quality throughout the product life cycle.
- Strategic CAPA management on local and global levels
- CAPA warning letter and violation trend analysis
- Differentiating between corrections, corrective actions and preventive actions
- Key considerations when evaluating CAPA tools
Participants that will find this webinar most beneficial will be those involved in medical device, pharmaceutical, and biotechnology companies. Job titles of attendees that will be most applicable for this session will be:
- Quality Assurance/ Quality Systems
- CAPA Managers
- Quality & Compliance
- Manufacturing & Operations
Sr. Director, Global Quality Systems
Lonnie Lassmann, Sr. Director, Global Quality Systems, KCI
Lonnie Lassmann currently serves as Sr. Director, Global Quality Systems for KCI. Lonnie has over 19 years experience in the medical device and aerospace industries working in various functional areas including operations, engineering, and quality. He is ASQ certified in CMQ/OE and CQA and is a certified Six Sigma Black Belt. He has a Master’s Degree in Business and a B.S. in Biomedical Engineering. He has been an active community volunteer serving on the board and committees for a variety of non-profit organizations, including the Quality Texas Foundation as a Board Examiner for the Baldrige Criteria for Performance Excellence.