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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