Day 1

Topics to be covered

Why Validation ?

  • Why the need for Validation came in to picture.
  • History Of Validation
  • Benefits of Validation
  • V Module
  • How we can get Good System
  • Validation Definition
  • GAMP4 V/S GAMP5
  • Types of Validation Prospective, Concurrent and Retrospective.

Validation Documentation

  • Validation Plan and Validation Report
  • Supplier Agreement
  • Vendor Assessment Report
  • GAMP5 Basics
  • GAMP5 Drivers
  • Software and Hardware category as per GAMP5

21 CFR Part 11 Compliance in Details, Data Integrity and Security. Basic and Advance Two Session

  • Main points
  • Legacy System
  • Open System
  • Close System
  • Electronic Records
  • Hybrid Systems
  • Electronic Signature
  • Digital Signatures
  • Black box & White box
  • Data backup – Restoration, Archival- Retrival and data Retention.
  • Annex 11
  • Data Integrity and Security
  • ALCOA
  • Maintenance Qualification