Failures Investigation and Root Cause Analysis (RCA) 2019

Topics

• 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

Who should Attend

• 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