–Effective Investigations To Identify The Actual Root Cause And
How To Develop Effective CAPA Strategy To Eliminate Forever

May 15 – 16, 2019 Hyderabad, TS, India

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.

DAY 1 :


1. Introduction of Failure Investigation

  • Understanding basics of failures
  • Classifying failures
  • RImportance of failure Investigations and RCA
  • What FDA/EU Regulations Address Root Cause Analysis Requirements?

2. Determining Potential impact of failure to the pharmaceutical Product (API/Formulation)

  • Discussion about potential failures
  • Understand the difference types of Impact
  • Immediate Action Required

3. 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

4. Techniques Root Cause Analysis – How to do it

  • Right Investigation is an important element
  • Building fundamental understanding of unit operations & root cause assessment capability
  • Understanding causes of failures
  • Procedure and SOP of failure Investigations
  • Steps to be followed to identify effective Root cause

5. RCA Tools with Case studies

    Popular RCA tools include:

  • Cause and effect (“fishbone” or Ishikawa
  • Fault tree analysis (FTA)
  • Failure mode and effects analyses (FMEA) whys and 6 W 1H
  • How to do with examples
  • Regulatory reference on maximum expected Tool

6. Failure investigations –OOS/OOT and OOE/Laboratory incidents

  • Definition of OOS; OOT; OOE-OOX concept.
  • Handling of OOS –USFDA and EU-UK MHRA requirements of OOS.
  • Phase 1, phase 2 and phase 3 investigations and CAPA.
  • OOT procedural requirements and documentation and CAPA.
  • OOE Procedural requirements and its documentation and CAPA
  • Laboratory Incident/Event/Deviation Management.
  • OOS; OOT; OOE trending and how to address in Quality metrics.
  • Case studies from USFDA/EU observations.

DAY 2 :


1. Handling of deviations and its Investigations

  • Definition of Deviation w.r.t International regulatory agency USFDA and EU requirements of Deviation Management.
  • Discussion on how to address deviation;
  • Document and investigation
  • Root cause identification and CAPA monitoring and Deviation closure
  • How to address deviation in quality metric and Trend analysis of deviation

2. Handling of Market Complaints; Recall and its investigation and CAPA:-

  • Definition of market complaint.
  • How to handle Market complaints as per USFDA/EU requirements
  • Documentation and investigation of market complaint and CAPA
  • Product recalls definition.
  • Recall classifications and its country specific procedure (National and International)
  • Field alert report (USFDA FAR) and EU/MHRA alert system.
  • Recall documentation; Investigation and reporting and CAPA

3. Discussion about data integrity failures and its investigations

  • Key issues like computerised systems violations
  • Trail injection
  • Integration anomalies and reintegration and manual integration investigations

4. How to initiate CAPA on Failures and CAPA Management

  • Definition of CAPA.
  • CAPA triggered by failures on PQS elements.
  • CAPA form and its documentation.
  • CAPA monitoring through effectiveness verification

5. Documentation of FIR (Failure Investigation Report)

  • How to write Failures Investigation Report and Key Elements of the Investigation Report (RCA Report)
  • Discussion with one scientific investigation report template.

6. Tracking and Trending

  • Discussion about How to track and trending of investigations

7. Citing examples from Warning Letters/483 observations on improper investigations

8. Conclusion Notes

Questions and Answers by Expert

Certification Programme



Mercure Hyderabad KCP

Banjara Hills, Hyderabad, Telangana

May15th & 16th , 2019



Kalpesh Kumar Vaghela

Validation Expert

Kalpesh Kumar Vaghela, is the CEO of Infra Control Systems. He has 30 years experience as Software Validation Specialist, Expert Trainer CSV, cGMP, Data Integrity, GAMP5, 21 CF Part 11 Compliance, ICH Q9, Risk Assessment. He has also worked in Elecronics and Instrumentation Engineering fields. Since last two decades Mr. Vaghela has been helping Indian and International Pharma Companies achieve Compliance by training and motivating professionals for Right First Time Approach. He has supported many USFDA, MHA, ANVISA, MCC, TGA Customer Audits, as a consultant.

Over 10 year of work experience on high level CSV Validation in India and Abroad has made Mr. Vaghela an expert in special Data integrity Audit for Pharma Industry. He has worked with and trained professionals in numerous major Indian companies. He has close to a decade of international experience of working with companies located in USA, Canada, South America, Norway, Africa, Middle East, Japan and Far East. Wherever he has worked and trained, he has unanimously been recognized as a brilliant course director and guide.

Mr. Vaghela has joined hands with Compliance Trainings as an Expert Trainer and Consultant with a common mission to share knowledge and empower the Indian Life Sciences Industry.

G. Sundar

PharmQA Consultant

Mr. Sundar Ganesan is a quality practitioner with 24 + years’ experience in the field of Quality Assurance, Quality Control, Bioequivalence and Pharmaceutical Regulations. His quality management experience covers the implementation of Quality tools in bulk drugs, formulation companies and CRO. He is an expert in Total Quality Systems as per GLP, GDP and as per EMEA, USFDA, MHRA and MCC, TGA, ANVISA and Japan guidelines. He assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance and establish more robust quality systems so that the company can succeed. Mr. Ganesan currently working as Director-Consultant at PharmQA Compliance services an independent consultant firm partners with US and Europe.

Brian G. Nadel

ex-FDA Official

Brian G. Nadel is the sole proprietor of a CGMP consulting firm. Mr. Nadel has over 25 years of diverse experience in Pharmaceutical Quality Assurance, Quality Systems, Remediation, Pre-Approval Inspections, International CGMP auditing, Gap Analysis, Change Control, CAPA, Active Pharmaceutical Ingredients, Fermentation, Process Validation and Inspection Readiness.

Mr. Nadel utilizes his broad background to assess compliance issues and develop effective, efficient comprehensive systems to ensure CGMP compliance. He assists companies in maintaining and developing quality manufacturing operations. He has worked with NDA, ANDA, DMF, BLA and OTC product manufacturers. He has also conducted CGMP training for FDA, Industry, and at industry conferences. He has worked to assist clients to comply with the requirements of Consent Decrees. He has used his experience in the pharmaceutical and government regulatory industries to author SOPs in the quality and compliance areas.

Mr. Nadel was a Senior Director responsible for Supplier Quality, in the US Corporate Quality and Compliance department for a large pharmaceutical manufacturer. Previously, he was Senior Manager in another large US pharmaceutical manufacturer where he held the position of Pre-Approval Inspection Manager in the R & D Quality Assurance Department. He started his career as an Investigator for the US FDA as Drug Specialist in the New York City area. He was then promoted to the FDA’s Centre for Drug Evaluation and Research (CDER) in Rockville, MD, where he served as a Compliance Officer in the Office of Compliance, Division of Manufacturing and Product Quality. At CDER, his main responsibility was reviewing recommendations from the District offices for regulatory actions such as Warning Letters, Seizures, Consent Decrees, and Injunctions.

Mr. Nadel holds a Bachelors degree in Biology and is a Certified Regulatory Affairs Professional. He is a member of the Parenteral Drug Association and the Regulatory Affairs Professional Society. Mr. Nadel has spoken at several industry forums.

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