Failures Investigation and Root Cause Analysis (RCA)

Failures Investigation and Root Cause Analysis (RCA) 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) 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

Past Events

   Failures Investigation and Root Cause Analysis (RCA) 2019  2-3 May 2019, Ahmadabad, India (83775)
   Failures Investigation and Root Cause Analysis (RCA) 2019  25-26 Apr 2019, Hyderabad, India (83776)

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