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Subscribe NewsletterRoot Cause Analysis and Documentation Requirements for CAPA
Product Id
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600206
Overview: RCA is a popular topic and many companies realize its importance in correcting problems. However, there is still much confusion and many problems continue to recur.
This webinar will use thoughtful discussion, humorous analogies and case studies to distinguish between the true root cause and other common imposters. Emphasis will be placed on realizing system interactions and cultural environment that often lies at the root of the problem and prevents true root cause analysis.
This webinar will use thoughtful discussion, humorous analogies and case studies to distinguish between the true root cause and other common imposters. Emphasis will be placed on realizing system interactions and cultural environment that often lies at the root of the problem and prevents true root cause analysis.
Why should you attend: This training will help individuals to recognize and address the true root cause for significant or chronic issues so corrective actions will be sufficiently robust to prevent a recurrence. This training will also build competence and confidence to address uncertainties and fear surrounding documenting CAPA activities that may likely be scrutinized by FDA and other outside auditors.
Areas Covered in the Session:
- How the organizational culture and environment encourages problems
- Role of Management and system interactions in causing problems
- Root Cause Analysis Methods & Practical Applications
- Case study examples to distinguish between assignable causes, enabling factors and root causes
- System Thinking: Moving from a reactive to a proactive environment
- Solution Development and Error Proofing
- Documentation Requirements
Who Will Benefit: This discussion will provide individuals with the necessary tools to understand problems and prevent them from recurring and should be of interest to:
- QA and Manufacturing Managers
- Engineers
- Supervisors
- Consultants
- Auditors, and responsible executives or other individuals responsible for managing the CAPA system and resolving problems in any organization.