Event
Course Description
Good Documentation Practices (GDP) is essential in regulated manufacturing and laboratory environments. Personnel in these fields need to closely adhere to GDP in order to ensure an auditable account of work performed. GDP is required for all documentation included in a fully developed quality system. This live webinar will cover USP–NF General Chapter <1029> and an overview of GDP, including guidance for writing and correcting documentation as well as the various documentation required by U.S. FDA 21 CFR Part 11 (electronic records and electronic signatures) as applicable to all stages of product development.
Upon completion of this course, you will be able to:
- Recall the definition, purpose, and importance of Good Documentation Practices
- Describe USP <1029> and its importance in GDP
- Demonstrate knowledge of the rules governing medicinal products in the EU (Vol. 4:
- Identify and describe outcomes of FDA warnings related to lack of GDP compliance
- Explain the proper handling of e-records and e-signatures (21 CFR Part 11)
Identify :
- general rules and principles of GDP
- records requirements
- general laboratory notebook documentation requirements
Who should take this course?:
- R&D
- QA/QC
- Manufacturing
- Production personnel
- Scientists • Researchers
- Batch record reviewers
- QA/QC specialists and auditors
- Validation specialists