How CAPA's are executed and managed is crucial to maintaining a compliant organization. Inadequate CAPA processes continue to be a major GMP deficiency and consistently make the FDA's top five list for adverse observations.
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 to the safety of patients and customers, and to describe the structure and function of an effective CAPA system.
Why should you Attend: It is always about success not failures right? But in the life sciences we must address failures as well. Complaints and product issues must be handled expeditiously according to regulation or we will suffer the wrath of the FDA.
Regulatory audits and FDA 483 regulatory observations are the two events that are a constant worry for managers in regulatory industries. In terms of the FDA, from 2012 to 2016, the FDA has increased the number of warning letters issued by over 1200%. This is the primary reason that understanding CAPA and having a comprehensive CAPA system is critical to maintaining regulatory compliance.
A CAPA system can help to identify problems before they become critical, can go a long way in the development of positive relationships with regulatory agencies by instilling confidence in your company's ability to identify and solve problems quickly and effectively, and further that confidence by convincing regulatory bodies and clients that identified problems have been resolved. Following the guidance provided in this webinar will help to reduce nonconformance to procedures, improve the quality of the work that you do, and significantly minimize customer complaints.
Areas Covered in the Session:
- 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
- Root Cause Analysis
Charles H. Paul,
C. H. Paul Consulting, Inc.
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, manufacturing, training, and technical documentation consulting firm – celebrating its twentieth year in business in 2017. He has been a regulatory and management consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.
He has held senior positions in consulting and in corporate training development prior to forming C. H. Paul Consulting, Inc.. He also worked for several years in government contracting managing the development of significant Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military.
He has dedicated his entire professional career explaining the benefits of performance-based training