Effective Corrective and Preventive Action Program (CAPA): The Role of Corrective Action and Preventative Action in Your Quality Management System

Duration: 75 Minutes
Corrective and Preventive Actions (CAPAs) are a beneficial tool for documenting potential problems and investigating them through root cause analysis. Today, more companies are utilizing CAPAs to properly document investigations and capture the action taken by the company. This session will cover the CAPA process, how to implement an effective CAPA system using a risk-based approach and review the key elements of a CAPA report.
Corrective and Preventive Action Program
Instructor: Susan Leister
Product ID: 501961
This training will benefit manufacturers of cGMP products in designing an effective, robust and compliant CAPA investigation system in order to avoid FDA or other regulatory bodies' inspection findings in these areas.

Objectives of the Presentation
Upon completion of this training, you will be able to:
  • Explain the requirement of 21 CFR Part 211 and 21 CFR Part 820.100, FDA Guidance's and other regulatory bodies' compliance requirements applicable to CAPA
  • Describe the differences between CAPA and SCAR (Supplier Corrective Action Reports), their impact to product release turnaround time as well as the advantages of the different tools that are used for CAPA investigation (manual versus electronic CAPA investigation systems) and best practices within the industry
  • Discuss the different types of electronic CAPA systems, advantages and disadvantages of different systems and what to look for when choosing an electronic CAPA system
  • List the basic requirements of a quality system investigation, current trends and how to design a compliant and efficient quality investigation system (CAPA) in order to avoid FDA findings relating to Quality Systems Investigation
Why should you Attend
There have been several form 483's and warning letters issued to companies by the FDA as it relates to CAPA investigations because of insufficient or incomplete quality systems procedures applicable to the program. Addressing an FDA form 483 or Warning Letter with findings associated with a CAPA system must be performed adequately, completely and must provide enough details within the CAPA procedure to ensure an effective CAPA investigation and effectiveness check. All failure, deviation or out of specification investigations must be adequately documented, corrected, prevented and checked for corrective action effectiveness through the use of a compliant CAPA investigational system and program. The result of a product investigation impacts the quality of the cGMP manufactured product label claim, to avoid it from being termed ‘adulterated' by the FDA which may result in product recalls, complaint and further actions by the FDA.

Areas Covered
  • CAPA Requirements, Regulations and Application
    • Understanding requirements of 21 CFR Part 211 and 21 CFR Part 820.100
    • Definition, application tools and types of CAPA (Differences between CAPA and SCAR) to include manual and electronic CAPA systems as well as the advantages and disadvantages of each type
  • Electronic CAPA Investigation System (Choosing a the Right CAPA Investigation Program)
    • Types of Electronic CAPA Investigation Systems/Programs and Critical aspects of the initiation evaluation of a CAPA Investigation System/Program
    • Important considerations during the evaluation of an Electronic CAPA System/ Program and how to choose the right system
  • Designing a Compliant and Robust CAPA Investigation Program
    • Impacted departments, roles associated with CAPA, completing a CAPA investigation and regulatory requirements of a complaint CAPA investigation system/program
    • Current trends in CAPA applications, Investigation and impact on product release turn-around time
  • Question and Answer Session
Who will Benefit
This webinar will provide a great resource to Pharmaceutical, Biotechnology and Medical Device Industries personnel within the following departments:
  • Quality Control Personnel & Management
  • Manufacturing Personnel & Management
  • Senior Management
  • Regulatory Affairs Personnel & Management
  • Quality Assurance Personnel & Management
  • Supplier Quality Personnel & Management
Recorded Session for one participant
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  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dr. Susan Leister serves as the director of quality assurance at Technical Resources International Inc. with over 20 years of experience in the pharmaceutical and medical device industry. She has validated over 40 software systems in the past few years and is very fluent in software validation requirements and compliance. She is also faculty for both graduate and undergraduate studies at the University of Phoenix. In addition to a bachelor's degree in biochemistry and molecular biology, she has an MBA, a doctorate in organizational management with a focus on leadership, and holds certifications from the American Society of Quality (ASQ) as a Certified Quality Auditor and a Six Sigma Black Belt.Dr. Leister has broad experience in GCP, GLP, and cGMP. She serves the ASQ Section 509 Executive Committee as the chair-elect and has been serving for the past four years as a Maryland Performance Excellence Award Examiner.
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