Pharmaceutical Quality: QRM, CAPA & Root Cause Analysis
TBC 2021, live online training
This unique online training course is designed for pharmaceutical quality professionals. Delegates will examine Root Cause Analysis(RCA) techniques by applying them to practical examples from the industry. Learn how to meet Corrective Action Preventive Action (CAPA) audit expectations and to maintain control over product and processes in a GMP environment.
Who should attend?
QA Managers and Inspectors, QC Laboratory Managers, Qualified Persons, Regulatory Compliance Managers, Production Managers, Formulators, Process Validation and Scale-up Specialists, Process Development Managers, Regulatory Compliance Managers, Chemical Engineers
- Application of Quality Risk Management (QRM)
- Regulatory Requirements for RCA, CAPA and OOS
- Causal Analysis: Definition of different types of cause
- RCA techniques, concepts and stages
- Data acquisition and Task analysis
- Principles of Critical Deviation Management (CDM)
- CAPA Audit expectations
- Training, re-training and Human Error
- All training materials provided in digital form
- All delegates will receive digital and LinkedIn certificates
- CAPA is the pharmaceutical process which outlines how to undertake activities to maintain control over product and processes in a GMP environment
- Without a thorough understanding of CAPA, and the accompanying need for RCA, companies will spend a lot of time and effort in repeatedly correcting faults rather than establishing procedures that will prevent these faults from occurring
Dr. Ross has over 35 years experience in the Generics Industry, the last 15 being at corporate level. He has been intimately involved in strategic planning, pipeline management and related activities.