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An Interactive Guide to Good Documentation Practice

This module is designed to review some aspects related to creation, implementation, archiving, storage and destruction of documents in GxP environments. It goes onto discuss common failures in good documentation and steps to ensure integrity of data generated

  • What is GDP, its need and its Impact.

  • Who enforces GDP

  • Types of Documentation, Responsibilities and Signatories for these document types

  • Do’s and Don’ts when handling documents and while making corrections in documents

  • Documentation Life Cycle

  • Document qualities

  • Implementation & distribution

  • Storage & Archival

  • Destruction and disposal

Why it matters

The accurate capture of information plays an important role in the manufacture of pharmaceuticals and medical devices. Documentation is key to GMP compliance as it ensures traceability of all development\, manufacturing\, and testing activities. It also provides the route for auditors to assess the overall quality of operations within a company and its final product.

Who is it for

This course is designed as basic training for all personnel involved in pharmaceutical manufacturing\, quality\, and engineering. It’s also relevant to employees in supply chain\, accounts\, finance and IT

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