Risk Assessment in CSV

Areas Covered in the Session :

  • CSV Components and Deliverables
  • URS, FS & DS
  • TRM, SR, IRA and FRA
  • Risk Based Approach for CSV
  • Understanding Risk Assessment
  • Risk-Based Validation approach to lower costs
  • Regulatory Expectations
  • Examples and Good Practices
  • Benefits of risk in larger project

Who Should Attend:

  • Quality Control & Quality Assurance
  • Research and Development
  • Laboratory
  • Regulatory Compliance
  • IT/IS & Software Departments
  • Validation
  • Production & Manufacturing
  • Documentation
  • Training Departments

ICT117

Kalpesh Kumar Vaghela

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.

membership

JUST RELEASED
SEMINARS
&
WORKSHOPS
 





  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.