CAPA, no matter how you look at it, is the heart of the quality management system. CAPA can be viewed as and is the merging of change control, continuous improvement, and complaint management.
What does the CAPA system do for the organization? CAPA not only indicates the organization's ability to respond to problems that arise but also to proactively anticipate and prevent subsequent problems from arising.
This webinar highlights the various regulations governing CAPAs, how CAPAs are successfully initiated and managed, how CAPA is an integral part of the quality system, and how an effective failure investigation and root cause analysis is accomplished. 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 system. At the completion of this webinar, you will be able to:
Explain the purpose and function of CAPA
Identify and explain the relevant CAPA regulations
Define exception/deviation reporting and explain the process of executing the reporting process
Explain and trace the CAPA flow from problem identification to resolution
Explain the challenges and pitfalls of the CAPA process and how they are overcome
Explain CAPA's role in risk mitigation
Explain how root cause analysis is executed
Why you should 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 Relevant Regulations
CAPA Process Flow
CAPA Process Steps Explained
Challenges and Pitfalls of CAPA's
CAPA and Risk Mitigation
Root Cause Analysis
Who Will Benefit:
Staff within all functions within the Organization to include Quality and Regulatory functions that are responsible for Interacting, Initiating, Managing, or Investigating CAPA's
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
Netzealous LLC, DBA -Compliance4all
Email: [email protected]