Good Documentation Practice and Record Keeping Regulations (FDA & EMA) 2018
04 Oct 2018
Webinar
Description
Good Documentation Practice and Record Keeping Regulations (FDA & EMA) 2018 is a webinar dedicated to general rules and principles of GDP which applies to laboratory notebook documentation, US Pharmacopeia General Chapter.
Topics
General Rules and Principles of GDP
General Tips in GDP:
Requirements of Records
General Tips for Laboratory Notebook Documentation:
Definition, Purpose, and Importance
Rules Governing Medicinal Products in the European Union (Vol. 4: Documentation)
Outline of EU GDP Regulations
What is new in the Latest Version?
US Pharmacopoeia General Chapter 1029
GDP Enforcement (examples from FDA warning letters)
Who should Attend
Manufacturing & Production Personnel / Managers
Anybody who works in a regulated environment
Quality Assurance & Quality Control Personnel / Managers
Research and Development Personnel (R&D) / Managers
Validation Specialists
Laboratory Personnel / Managers
Project Managers
Clinical trial personnel
Past Events
Good Documentation Practice and Record Keeping Regulations (FDA & EMA) 2018 - 04 Oct 2018, Webinar (76368)
Good Documentation Practice and Record Keeping Regulations (FDA & EMA) 2025 ?
Important
Please, check "Good Documentation Practice and Record Keeping Regulations (FDA & EMA)" official website for possible changes, before making any traveling arrangements
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