This is the advanced and skill based training in specific subjects related to failures investigation and root cause analysis (RCA) –effective investigations to identify the actual, factual root cause and how to develop effective CAPA strategy to eliminate forever in good manufacturing processes and quality systems. This course details with current regulatory expectations on failures investigation and root cause analysis (RCA) with implementation of effective CAPA.
DAY 1 :
1. Introduction of Failure Investigation
- Understanding basics of failures
- Classifying failures
- RImportance of failure Investigations and RCA
- What FDA/EU Regulations Address Root Cause Analysis Requirements?
2. Determining Potential impact of failure to the pharmaceutical Product (API/Formulation)
- Discussion about potential failures
- Understand the difference types of Impact
- Immediate Action Required
3. The Investigation -Trigger (OOS/OOT/Deviation/Complaints/Recall/Other NC failures)Techniques
- Details discussions about triggering of failures from OOS/OOT/Deviation/Complaints/Recall/ Other NC failures) Techniques
4. Techniques Root Cause Analysis – How to do it
- Right Investigation is an important element
- Building fundamental understanding of unit operations & root cause assessment capability
- Understanding causes of failures
- Procedure and SOP of failure Investigations
- Steps to be followed to identify effective Root cause
5. RCA Tools with Case studies
- Popular RCA tools include:
- Cause and effect (“fishbone” or Ishikawa
- Fault tree analysis (FTA)
- Failure mode and effects analyses (FMEA) whys and 6 W 1H
- How to do with examples
- Regulatory reference on maximum expected Tool
6. Failure investigations –OOS/OOT and OOE/Laboratory incidents
- Definition of OOS; OOT; OOE-OOX concept.
- Handling of OOS –USFDA and EU-UK MHRA requirements of OOS.
- Phase 1, phase 2 and phase 3 investigations and CAPA.
- OOT procedural requirements and documentation and CAPA.
- OOE Procedural requirements and its documentation and CAPA
- Laboratory Incident/Event/Deviation Management.
- OOS; OOT; OOE trending and how to address in Quality metrics.
- Case studies from USFDA/EU observations.
DAY 2 :
1. Handling of deviations and its Investigations
- Definition of Deviation w.r.t International regulatory agency USFDA and EU requirements of Deviation Management.
- Discussion on how to address deviation;
- Document and investigation
- Root cause identification and CAPA monitoring and Deviation closure
- How to address deviation in quality metric and Trend analysis of deviation
2. Handling of Market Complaints; Recall and its investigation and CAPA:-
- Definition of market complaint.
- How to handle Market complaints as per USFDA/EU requirements
- Documentation and investigation of market complaint and CAPA
- Product recalls definition.
- Recall classifications and its country specific procedure (National and International)
- Field alert report (USFDA FAR) and EU/MHRA alert system.
- Recall documentation; Investigation and reporting and CAPA
3. Discussion about data integrity failures and its investigations
- Key issues like computerised systems violations
- Trail injection
- Integration anomalies and reintegration and manual integration investigations
4. How to initiate CAPA on Failures and CAPA Management
- Definition of CAPA.
- CAPA triggered by failures on PQS elements.
- CAPA form and its documentation.
- CAPA monitoring through effectiveness verification
5. Documentation of FIR (Failure Investigation Report)
- How to write Failures Investigation Report and Key Elements of the Investigation Report (RCA Report)
- Discussion with one scientific investigation report template.
6. Tracking and Trending
- Discussion about How to track and trending of investigations
7. Citing examples from Warning Letters/483 observations on improper investigations
8. Conclusion Notes
Questions and Answers by Expert
Fortune Landmark – Ahmedabad
Ashram Road, Ahmedabad, Gujarat
May 2nd & 3rd, 2019
Mercure Hyderabad KCP