Description:
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 course 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.
During this webinar, 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 the practical and how to best thoroughly accomplish an effective CAPA.
Areas to be Covered:
CAPA defined
CAPA relevant regulations
Exception/deviation reporting
CAPA process flow
CAPA process steps explained
Challenges and pitfalls of CAPA’s
CAPA and risk mitigation
Who will Benefit:
A must attend webinar for all personnel / companies in the Pharmaceuticals, Medical Devices, Biotechnology, Cosmetics, Personal Products, Foods & Beverages fields. The professionals who will benefit include all:
Manufacturing Department
Regulatory Affairs
Quality Professionals
Documentation department
Compliance officer
Product Development Professionals
QA/QC analysts
Internal Auditors
Quality Assurance scientists
Production
Operations
Consultants
Quality Unit managers and supervisors
Training Managers and Directors
