Webinar ID:   ICT132

Deviation Management and CAPA by Leveraging Effective Investigation

  90 Minutes

Categories:   Uncategorised,

CAPA violations along with ineffective complaint investigations continue to be the main cited violation of FDA warning letters for the past 10 years. So, we designed this training for all pharma professionals involved in Deviation Management and CAPA activities at their company. It specifically explores how to identify/detect the deviation and implement/practice CAPA processes effectively in day-to-day operations. What planning is necessary and how to investigate the root cause and do effective evaluation will be discussed.

Human error being the biggest reason quoted, we will discuss ways to investigate Human errors and how to fix it. We will analyze how to avoid pitfalls and minimize regulatory scrutiny by having a robust deviation/CAPA system and thorough investigations. The deviation process is explored and evaluated, and examples are given to demonstrate the best way to handle deviations and subsequent CAPAs. Attendees will have the opportunity to interact and ask questions about best practices regarding both devotions and the CAPA process. Reasons for having a robust deviation process are given with examples.

How to investigate deviation successfully? What are the tips and tricks to reduce and eliminate observations? Ensure compliance by learning best methods in identifying and avoiding potential pitfalls during deviation investigations and implement an effective CAPA Process. Join our expert, Mr. Umesh Baikunje for this important and interactive webinar.

Areas Covered in the Session :

  • Regulatory requirement and expectations
  • How to identify/detect the deviation and implement/practices CAPA processes effectively in day -to – day operations.
  • How to plan, investigate the root cause and do effectiveness evaluation
  • How to investigate Human errors.
  • Where, when & how to document CAPA
  • What are the biggest Opportunities of the CAPA system and how to fix it?
  • Some common myths on deviations and CAPA
  • Determining Root Cause and Effective/Sustainable CAPA to avoid 483 observations
  • Tips on how to avoid possible pitfalls with deviations
  • Requirement of effective CAPA program
  • Future way of handling deviation and CAPA, regulatory review

Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Research and Development Departments
  • Manufacturing Departments
  • Engineering Departments
  • Production Departments
  • Operations Departments
  • Regulatory Affairs Departments
  • Deviation Investigators
  • IT personnel working in GxP environment
  • Compliance Auditors
  • Everyone who Reviews and Approve Deviation Investigations and are involved in Deviation Management and CAPA activities


Umesh Baikunje

Umesh Baikunje, the founder and CEO of Baikunje Consultancy, has 25 years of hands-on experience in product quality management and regulations in the pharma/biopharma industry. He has helped pharmaceutical, biopharmaceutical companies and CROs to identify, prevent and resolve compliance problems and implement quality systems. His expertise is beefed by a deep understanding of working cultures across continents including Asia, Europe and the US.