What
You’ll Learn
You’ll Learn
- Understanding CAPA Fundamentals – Learn the key principles
- regulatory expectations
- and industry best practices for CAPA implementation.
- Root Cause Analysis Techniques – Master proven methodologies like 5 Whys
- Fishbone Diagram
- and FMEA to identify and eliminate root causes.
- CAPA Investigation & Documentation – Develop a structured approach to document
- investigate
- and verify CAPA effectiveness.
- Regulatory Compliance & Audit Readiness – Align CAPA processes with FDA
- WHO
- EU GMP
- and ICH Q10 requirements to ensure compliance.
- Risk-Based CAPA Implementation – Learn how to prioritize CAPA actions using risk management principles and data-driven decision-making.
- Preventive Action Strategies – Go beyond corrective actions by proactively identifying potential failures and implementing long-term preventive measures.
- Measuring CAPA Effectiveness – Track CAPA performance using key metrics and trend analysis for continuous improvement.
Requirements
- “No prior CAPA experience is required! Whether youre a beginner or an experienced professional
- this course will provide step-by-step guidance to effectively manage CAPA processes.”
Description
The Corrective and Preventive Action (CAPA) Management course for pharmaceuticals equips participants with essential skills and knowledge to effectively manage and implement CAPA processes within the pharmaceutical industry. CAPA is a crucial aspect of quality management systems, aimed at identifying, addressing, and preventing non-conformances and deviations to ensure continuous improvement and regulatory compliance.
Throughout this course, participants will gain a comprehensive understanding of the CAPA lifecycle, starting from the identification of issues through root cause analysis, implementation of corrective actions, and the establishment of preventive measures to prevent recurrence. Key topics include:
-
Regulatory Requirements: Understanding regulatory expectations and guidelines for CAPA in pharmaceutical manufacturing, including FDA and EMA standards.
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Root Cause Analysis: Techniques and methodologies for identifying the root causes of deviations and non-conformances to prevent their recurrence.
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CAPA Plan Development: Developing effective CAPA plans that are systematic, measurable, and aligned with organizational goals.
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Implementation and Monitoring: Strategies for implementing CAPA actions effectively and monitoring their progress to ensure timely completion and effectiveness.
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Documentation and Reporting: Best practices for documenting CAPA activities and preparing comprehensive reports for regulatory agencies and internal stakeholders.
This course is designed for quality assurance professionals, regulatory affairs personnel, manufacturing managers, and anyone involved in pharmaceutical operations seeking to enhance their understanding and proficiency in CAPA management. Participants will leave with practical skills to drive continuous improvement and ensure the highest standards of product quality and compliance in pharmaceutical manufacturing environments.
Who this course is for:
- Quality Assurance (QA) & Quality Control (QC) Professionals – Ensure effective CAPA implementation to improve product quality and regulatory compliance.
- Regulatory Affairs Specialists – Understand CAPA expectations from FDA
- WHO
- EU GMP
- and ICH Q10 to maintain compliance during inspections and audits.
- Manufacturing & Production Personnel – Identify
- investigate
- and prevent recurring quality issues in pharmaceutical and biotech manufacturing.
- GMP Auditors & Compliance Managers – Strengthen audit readiness and CAPA documentation to meet regulatory expectations.
- R&D and Laboratory Professionals – Learn how CAPA applies to analytical laboratories
- method validation
- and process development.
- Pharmaceutical & Biotech Industry Professionals – Anyone responsible for ensuring continuous improvement in quality management systems (QMS).
