Day 2

Topics to be covered

Basic Concepts of CSV And Advantages of Validation If time permits

  • How validation helps to improve your business.
  • Computer Validation as per GAMP5
  • Why Validation ? Deliverables of the ValidationBenefits of Validation
  • VMP, URS, FS, DS, IRA, FRA, IQ, OQ, PQ, TRM, SR
  • Using risk based approach for CSV
  • Benefit of Risk Assessment

Steps for CSV If Time permits

  • Formation of Validation Team
  • Why to Write meaningful specifications / requirements (URS) Report
  • Deliverable SRS, GXP Assessment, Risk Assessment, IQ, OQ, Traceability Matrix, Summary Report
  • Risk Assessment Sod, RPN no
  • Selecting and qualifying the right vendor – Risk Based Approach as per GAMP category
  • Installing and testing the system for correct operation
  • Validation of existing system
  • Revalidation
  • Vendor Qualification, SLA
  • Difference between Qualification and Validation

Risk Assessment

  • Basic Understanding
  • Various types of Risk Assessment method
  • Example
  • Benefit of risk assessment in large project