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

Future Events

Failures Investigation and Root Cause Analysis (RCA) 2020


Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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