Failures Investigation and Root Cause Analysis (RCA) 2019 is a workshop that covers topics such as:
- Determining Potential impact of failure to the pharmaceutical Product (API/Formulation)
- Understand the difference types of Impact
- Discussion about potential failures
- Immediate Action Required
- Introduction of Failure Investigation
- Classifying failures
- Understanding basics of failures
- What FDA/EU Regulations Address Root Cause Analysis Requirements?
- RImportance of failure Investigations and RCA
- Techniques Root Cause Analysis - How to do it
- Building fundamental understanding of unit operations & root cause assessment capability
- Right Investigation is an important element
- Procedure and SOP of failure Investigations
- Understanding causes of failures
- Steps to be followed to identify effective Root cause
- 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
- Failure investigations -OOS/OOT and OOE/Laboratory incidents
- Handling of OOS -USFDA and EU-UK MHRA requirements of OOS
- Definition of OOS; OOT; OOE-OOX concept
- OOT procedural requirements and documentation and CAPA
- Phase 1, phase 2 and phase 3 investigations and CAPA
- Laboratory Incident/Event/Deviation Management
- OOE Procedural requirements and its documentation and CAPA
- Case studies from USFDA/EU observations
- OOS; OOT; OOE trending and how to address in Quality metrics
- RCA Tools with Case studies
- Cause and effect ("fishbone" or Ishikawa
- Popular RCA tools include:
- Failure mode and effects analyses (FMEA) whys and 6 W 1H
- Fault tree analysis (FTA)
- Regulatory reference on maximum expected Tool
- How to do with examples
- Handling of Market Complaints; Recall and its investigation and CAPA:-
- How to handle Market complaints as per USFDA/EU requirements
- Definition of market complaint
- Product recalls definition
- Documentation and investigation of market complaint and CAPA
- Field alert report (USFDA FAR) and EU/MHRA alert system
- Recall classifications and its country specific procedure (National and International)
- Recall documentation; Investigation and reporting and CAPA
- Handling of deviations and its Investigations
- Discussion on how to address deviation
- Definition of Deviation w.r.t International regulatory agency USFDA and EU requirements of Deviation Management
- Root cause identification and CAPA monitoring and Deviation closure
- Document and investigation
- How to address deviation in quality metric and Trend analysis of deviation
- How to initiate CAPA on Failures and CAPA Management
- CAPA triggered by failures on PQS elements
- Definition of CAPA
- CAPA monitoring through effectiveness verification
- CAPA form and its documentation
- Discussion about data integrity failures and its investigations
- Trail injection
- Key issues like computerised systems violations
- Integration anomalies and reintegration and manual integration investigations
- Tracking and Trending
- Discussion about How to track and trending of investigations
- Documentation of FIR (Failure Investigation Report)
- Discussion with one scientific investigation report template
- How to write Failures Investigation Report and Key Elements of the Investigation Report (RCA Report)
- Citing examples from Warning Letters/483 observations on improper investigations
Failures Investigation and Root Cause Analysis (RCA) 2019 brings together:
- Quality Control Management and Staff
- Quality Assurance Management and Staff
- Regulatory Affairs Management and Staff
- Research and Development Management and Staff
- Engineering Management and Staff
- Manufacturing Management and Staff
- Production Management and Staff
- Operations Management and Staff
- Process Owners
- Validation Management and Staff
- Quality Auditors
- Documentation Management and Staff
