Course Description:
Good Documentation Practices is an essential element 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 self-paced e-learning course will cover all aspects of GDP, including practices for writing and correcting documentation as well as the various documentation and record keeping requirements as per the US FDA CFR sections (21 CFR 11, 58, 211, 312, 812), EU regulations, and ICH guidelines, as applicable to non-clinical laboratory studies, pharmaceuticals and medical device.
Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
Objectives:
By taking this course, you will learn
- General principles, definition, application, and importance of GDP
- Regulatory applications of GDP
- Document and record creation, approval, handling, and retention
- Document maintenance and modification
- Time/date recording and rounding rules
- Proper way of dealing with deviation, use of signature and initial, correction of errors and omissions
- Raw data attachments to documentation
- Proper use of electronic records and e-signatures in relation to 21 CFR part 11
- Update on proposed USP Chapter <1029> announced in PF 41(5)
- European Medicines Agency (EMA) updates on the changes in GDP as of 2011 revisions
Who Should Participate:
- Manufacturing/production personnel
- R&D laboratory personnel
- Scientists and researchers
- Batch record reviewers
- QA/QC specialists
- Validation specialists
- Quality auditors