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This interactive course with workshops is designed to bring you up-to-date with the current regulatory expectations for Good Documentation Practice. The course aims to provide you with the guidance and tools to understand and implement the Good Documentation in the context of GDP and GMP.
Anyone interested in Good Documentation Practice requirements
08:30 - 09:00
Registration & coffee
09:00 - 17:00
Course (lunch included)
per participant (excl. VAT)
✓ Exclusive learning approach
✓ Personal course documentation
✓ Lunch, water, coffee & tea
✓ Course certificate after completion
Quastion Learning Center (Qplus consult BVBA)
Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium
Why is good documentation practice important?
Responsibilities within organization
Basic principles which should always be applied
Do’s and don’ts
Learn Which Activities Need to be Recorded and Retained
Overview of activities which should be recorded for GMP and GDP activities
How to establish a Document Management Process
Practical approach and roll-out within organization
Documents Access and Security
Guidance on paper documents
Requirements to electronically managed documents
Document Creation, Review and Approval
Rules on document creation
Review of documents
Approval of documents
How to modify documents, what is acceptable and what is not
Allowed or not?
When allowed, how to proceed
Copies of Documents
How to replicate documents
Controlled and uncontrolled?
Do’s and don’ts
Who is responsible?
Inspectorate Expectations to Document Management Process
Inspectorate expectations to Document Management process
Industry best practices