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Implementing an Effective CAPA System
- CAPA defined
- CAPA relevant regulations
- Exception/deviation reporting
- CAPA process flow
- CAPA process steps explained
- CAPA and risk mitigation
- Challenges and pitfalls of CAPAs
Overview of the webinar
How CAPA’s are executed and managed is crucial to maintaining a compliant organization. Inadequate failure investigations continue to be a major GMP deficiency and consistently make the FDA’s top five list for adverse observations. This webinar highlights the various regulations governing CAPAs, how CAPAs are successfully initiated and managed and how an effective failure investigation and root cause analysis is accomplished.
The primary objective of this webinar is to heighten awareness of the importance of the proper execution of the CAPA process to the organization, to the efficacy of the product and the process and to the safety of patients and customers. This webinar will begin by defining CAPA in terms of its importance to regulated industries and to the protection of the patient, users, the public and the product itself. CAPA is governed by regulations – specific regulations that must be understood and followed for your CAPA process to be compliant. These regulations will be covered to ensure that a proper knowledge foundation is laid. Next and for the remainder of the webinar, the CAPA process flow will be discussed and explained. The webinar will end with a discussion of the challenges and pitfalls of the CAPA process.
Who should attend?
Anyone involved in the manufacture of pharmaceutical products, foods, beverages, cosmetics, medical devices that have had some exposure to the subject area, manufacturing and regulated environments.
Why should you attend?
During this webinar, an emphasis is placed on the application and practical aspects of the process to include its critical steps, CAPA timing, participants to the process, roles and functions, and the pitfalls associated with CAPA investigations. The content of the webinar will focus on how to best thoroughly accomplish an effective CAPA.
Faculty - Mr.Charles H. Paul
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems.