implement-an-effective-corrective-and-preventive-action-capa-process

Implement an Effective Corrective and Preventive Action (CAPA) Process

Live Webinar

  • 60 minutes
  • 6 Days Left
     Aug 14, 2020
  •   01:00 PM - 02:00 PM ET
    10:00 AM - 11:00 AM PT

The CAPA controls rely on three important concepts namely, remedial correction; understanding the root cause and come up with corrective actions; and to have preventive actions to avert recurrence. If the root cause analysis is not done correctly, all the subsequent steps towards correction and prevention would be rendered ineffective and cause the issue to reoccur. 

As simple as it sounds, the Root Cause Analysis and CAPA has always posed challenges to the organization and has been the #1 reason for 483 observations and Warning Letters for the last 15 years. 

Join this session with expert speaker Ajit Basrur, where he will highlight the various regulations governing Corrective and Preventive Actions (CAPA) and how organization should collect information, analyze information, identify, investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence. 

Session Highlights:

 This webinar will cover the following topics.

  •  Introduction 

  • Background, 

  • Key Definitions

  •  FDA, ICH and ISO Requirements 

  • Quality System Inspection Techniques (QSIT), Nonconformity and CAPA Inputs

  •  Root Cause Analysis tools: 8-Disciplines (or 8D), 5 Whys, Fishbone (Ishikawa) Diagram and Brainstorming

  •  Examples of RCA and CAPA 

  • Risk based approach 

  • Management review 

  • FDA 483s and Warning Letters 

Why You Should Attend: 

You will learn insights into root cause analysis and develop a logical approach to problem solving by correctly identifying causes of problems and have permanent solutions in place. This would go a long way in organizational success. 

Who Should Attend?

  • General Managers, 

  • QA / QC Managers, 

  • CAPA Managers, 

  • Compliance Officer, 

  • Quality Engineers, 

  • Operations Manager, 

  • Management Representative, 

  • Internal auditors, 

  • Training Manager 

  • Any other team member from the quality, operations, customer service, facility maintenance and metrology departments wishing to contribute in the CAPA activities and investigations.


You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Ajit Basrur

Ajit Basrur

Ajit Basrur is an experienced quality professional in Pharmaceutical and Medical Devices with over 35 years of experience in global compliance. He is a Certified Lead Auditor for ISO 9001, and ISO 13485 quality management systems. He is also ASQ Certified Pharmaceutical GMP Professional, Certified Medical Device Auditor and a Scientific Peer Reviewer for ASQ’s Software Quality Assurance.

Ajit has vast experience in pharmaceutical quality systems across 21 CFR Parts 210/211, ICH, IPEC and WHO standards and Guidelines for cGMP and GDP (Good Distribution Practices); experience in medical device quality systems across 21 CFR Parts 800-821 and 830, 21 CFR Part 4, ISO 13485, EU MDR, CMDCAS, JPAL, RDC ANVISA (Brazil), and MDSAP standards; and Cosmetics experience across FDA and EfFCI Guidelines. His expertise is in audits, compliance, quality system remediation, and establishing quality systems to meet regulatory and customer expectations He has a strong track record of success in remediation efforts driving effective results in difficult situations on a global basis.

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