Corrective & Preventive Action – A Physiological Analogy and Practical Application
Date: September 19, 2019
Location: Holiday Inn, Marlborough, MA
Dinner Meeting Agenda:
6:00-6:30 PM – Networking
6:30-7:15 PM – Dinner
7:15-7:30 PM – Section Business
7:30-8:30 PM – Dinner Presentation
The goal of this 1-hour session is to show through an interesting physiological analogy how the CAPA process gets implemented by the human body when there is a non-conformity in terms of a wound, and how to implement it most efficiently in practice in the workplace. Finally, we will go over some dos and don’ts for CAPAs.
The session will cover:
- The importance of CAPA from a business perspective
- An analogy of the human body CAPA system
- The parallels between the 8 steps of CAPA when the human body encounters a non-conformity
- An example of how best to implement a CAPA system in practice using 3-tiered CAPA loops and flexible responsibilities
- Some Dos and Don’ts when implementing CAPA
Presenter: Raj Kasbekar
Raj Kasbekar is Global Vice President of Regulatory, Quality Systems, and Clinical Affairs at Kaz USA, Inc., a Helen of Troy Company. Helen of Troy is a 1.6 billion-dollar company with leading brands such as Vicks, Braun, Honeywell, Revlon, Dr. Scholl’s, etc. and products that are sold globally.
Raj Kasbekar has more than 20 years of experience in management, regulatory affairs, clinical affairs, quality systems, program management, and product quality and has held wide-ranging positions including RA/QA Leader at GE Healthcare, RA/QA Manager at Hologic, besides consulting assignments at many reputed Fortune 100 companies.
Raj Kasbekar has four ASQ certifications, including Certified Six Sigma Green Belt. He has an extensive medical device background and has been instrumental in commercializing several products, implementing Quality systems at startup and large companies, and handling over 20 FDA and ISO audits. He has Bachelor and Master Degrees in Engineering and an MBA. He has also published several peer-reviewed articles and white papers, and has patents pending.