Webinar ID:   ICT129

Root Cause Analysis and CAPA with Real-Time Case Studies – 3-Hour Virtual Seminar

  11 Nov 2020, 06:30 PM
  3 Hours

Categories:   Uncategorised,

Refer any Audit findings, there are two major Contributing factors, which make the Industry to suffer. One of these is Data Integrity and the other major contributor is Inadequate Investigations, leading to inappropriate Root Cause identification.

Today we are well equipped with many tools, which can be used for Investigations and arrive a precise Root cause. For example, 5 WHY, FMEA & FTA, Pareto’s chart, Ishikawa or Fish Bone Analysis etc. Then, why do we fail? Is it not owing to self-created limitations to use these tools? The webinar explains with Real time case studies, Effective use of Root Cause Analysis Tools so as to rationally / logically arrive a possible precise Root cause. An identified Root cause will help us in designing an Effective CAPA.

Finally, Establishing the Effectiveness of CAPA is the final Objective of the entire Investigation to arrive a Proper CAPA. The webinar also covers the different aspects, which can be used to evaluate Effectiveness of CAPA.

Areas Covered in the Session :

  • What is Root cause analysis (RCA) & Why should we perform RCA?
  • Principles of RCA
  • Elements of RCA
  • Who should perform RCA
  • How to perform RCA; Tools to perform RCA
    • Application of Root Cause Analysis Tools to arrive a Root Cause, using different tools, e.g. 5 WHY, FMEA & FTA, Pareto’s chart, Ishikawa or Fish Bone Analysis etc
  • Case studies with specific reference to common examples in industry
  • Designing CAPA and Establishing Effectiveness.

Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Manufacturing Departments
  • Production Departments
  • Operations Departments

ICT129

Vikram Kulshrestha

Vikram Kulshrestha has over 25 years experience in with strong Quality Assurance & Regulatory Affairs background. He has supported manu organizations to get USFDA, MHRA, TGA, MCC, KFDA, NDA and other International Accreditation. His expertise include API & Formulation manufacturing, Pre-inspections Gap analysis & compliance, Handling USFDA Warning letters, Post audit observations, cGMP, Validations & Qualifications, CAPA matters, Data Integrity, Quality Management Systems and Software validation, to name a few. He is a regular speaker at various workshops, in-house training, webinars and industry conferences.