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 recorded 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.
The live version of this course took place on May 28, 2019.
This course includes English subtitles.Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
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 participate:
- R&D
- QA/QC
- Manufacturing
- Production personnel
- Scientists
- Researchers
- Batch record reviewers
- QA/QC specialists and auditors
- Validation specialists
Why Choose USP Education?
USP Education provides year-round courses and programs on how to effectively interpret and apply USP’s internationally recognized quality standards. The standards help ensure the quality and safety of medicines, dietary supplements and foods.
USP courses are created by the scientists and experts who help develop the USP standards that are used worldwide. Courses are presented by approved instructors with practical, first-hand knowledge of the subject area and related standards. The insights they share will not only make your daily work easier, but will also connect you to an independent, nonprofit scientific body with the goal of creating a strong foundation for a healthier world.