FAILURES INVESTIGATION AND ROOT CAUSE ANALYSIS (RCA)
–Effective Investigations To Identify The Actual Root Cause And How
To Develop Effective CAPA Strategy To Eliminate Forever
Whenever regulatory authorities anywhere in the world perform an audit of a drug manufacturer, one of their most frequent findings remains the inadequate performance of the investigation of failures arises from Deviations; OOS and market complaints. Authorities expect stakeholders will carefully investigate failures to identify non-compliance, intervene and then evaluate the effectiveness of that intervention. Without adequate investigation and root cause analysis (RCA), those stakeholders cannot effectively identify and design successful interventions. In fact, organizations waste millions of dollars every year on ineffective interventions.
Many manufacturers run afoul of the FDA/EUGMP/ WHO over their corrective and preventive actions (CAPA) procedures, since CAPA can impact almost every area of your manufacturing operations, it’s crucial for all employees to understand at least the basics – the what, why and how. But boiling the complexities of Failures and in effective CAPA down the organisations into a severe regulatory non-compliance level and resolve the issue can be a real challenge.
Current Regulators expectations is that “A firm’s primary goals in investigating an Failure incident should include both discovering its cause and ensuring it does not reoccur.”
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.
01. Introduction of Failure Investigation
01. Understanding basics of failures
02. Classifying failures
03. Importance of failure Investigations and RCA
04. What FDA/EU Regulations Address Root Cause Analysis Requirements?
02. Determining Potential impact of failure to the pharmaceutical Product (API/Formulation)
01. Discussion about potential failures
02. Understand the difference types of Impact
03. Immediate Action Required
03. The Investigation -Trigger Techniques
01.Details discussions about triggering of failures from OOS/OOT/Deviation/Complaints/Recall/ Other NC failures) Techniques
04. Techniques Root Cause Analysis – How to do it
01. Right Investigation is an important element
02. Building fundamental understanding of unit operations & root cause assessment capability
03. Understanding causes of failures
04. Procedure and SOP of failure Investigations
05. Steps to be followed to identify effective Root cause
05. RCA Tools with Case studies
01. Cause and effect (“fishbone” or Ishikawa)
02. Fault tree analysis (FTA)
03. Failure mode and effects analyses (FMEA) whys and 6 W 1H
04. How to do with examples
05. Regulatory reference on maximum expected Tool
06. Failure investigations –OOS/OOT and OOE/Laboratory incidents
01. Definition of OOS; OOT; OOE-OOX concept.
02. Handling of OOS –USFDA and EU-UK MHRA requirements of OOS.
03. Phase 1, phase 2 and phase 3 investigations and CAPA.
04. OOT procedural requirements and documentation and CAPA.
05. OOE Procedural requirements and its documentation and CAPA.
06. Laboratory Incident/Event/Deviation Management.
07. OOS; OOT; OOE trending and how to address in Quality metrics.
08. Case studies from USFDA/EU observations.
01. Handling of deviations and its Investigations
01. Definition of Deviation w.r.t International regulatory agency USFDA and EU requirements of Deviation Management.
02. Discussion on how to address deviation.
03. Document and investigation
04. Root cause identification and CAPA monitoring and Deviation closure
05. How to address deviation in quality metric and Trend analysis of
02. Handling of Market Complaints; Recall and its investigation and CAPA
01. Definition of market complaint.
02. How to handle Market complaints as per USFDA/EU requirements
03. Documentation and investigation of market complaint and CAPA
04. Product recalls definition.
05. Recall classifications and its country specific procedure (National and International)
06. Field alert report (USFDA FAR) and EU/MHRA alert system.
07. Recall documentation; Investigation and reporting and CAPA
03. Discussion about data integrity failures and its investigations
01. Key issues like computerised systems violations
02. Trail injection
03. Integration anomalies and reintegration and manual integration investigations
04. How to initiate CAPA on Failures and CAPA Management
01. Definition of CAPA.
02. CAPA triggered by failures on PQS elements.
03. CAPA form and its documentation.
04. CAPA monitoring through effectiveness verification.
05. Documentation of FIR (Failure Investigation Report)
01. How to write Failures Investigation Report and Key Elements of the Investigation Report (RCA Report)
02. Discussion with one scientific investigation report template.
05. Tracking and Trending
01. Discussion about How to track and trending of investigations.
Citing examples from Warning Letters/483 observations on improper investigations
Questions and Answers by Expert
Fortune Landmark – Ahmedabad
Ashram Road, Ahmedabad, Gujarat
May 2nd & 3rd, 2019
Mercure Hyderabad KCP