Root Cause Analysis and CAPA Controls for a Compliant Quality System

Why Should You Attend:

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. Strong CAPA controls make an organization compliant and less vulnerable to customer complaints, nonconformance, deviations, etc. 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.

You will learn insights into root cause analysis and develop a logical approach to problem solving by accurately identifying causes of problems and have permanent solutions in place. This would help drive compliance and towards an organizational success.

Areas Covered in the Webinar:

• Introduction to include background, key definitions, and 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 FDA 483s and Warning Letters

Who Will Benefit:

• QA/QC Managers
• Operations Manager
• CAPA Managers
• Quality Engineers
• Management Representative
• Internal Auditors
• Training Manager

Ajit Basrur
Manager and Principal, Claritas Consulting LLC

Ajit Basrur, is owner of Claritas Consulting, LLC which provides Pharmaceutical, Medical device, Laboratories, and Cosmetics organizations with quality system compliance (including training), internal audits and supplier audits, to meet their customer, ISO and regulatory requirements. Prior to this role, Ajit has been in the regulated industry for 30 years serving in quality and production roles, and has demonstrated proven leadership in various elements of quality management systems (cGMP, GLP and regulatory requirements), audit and compliance, root cause analysis, problem solving and CAPA, change management, investigations, qualification and validation, quality tools and various aspects of regulatory affairs.

Ajit is a Certified Biomedical Auditor (ASQ CBA) and Certified Pharmaceutical GMP Professional (CPGP) and is well-versed with numerous standards and guidelines including but not limited to ISO 9001, ISO 13485, ISO 14644, ISO 14971, 21 CFR Part 4, 21 CFR Parts 210/211 and 21 CFR Part 820, ICH Q7, Q8, Q9, Q10, Q11, IPEC Excipient GMPs, ISO 11135, ISO 11137, ISO 14971, Gap analysis and quality system remediation, Internal audits, Supplier audits, and FDA Mock Audits.

Ajit holds a degree in Microbiology and has a global experience by working in India, China, Hong Kong, Singapore and USA.

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