.
Good Documentation Practices (GDP) is an essential element in regulated manufacturing and laboratory environments. Personnel working in these fields should adhere to GDP policy and regulations 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 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.

Subject area:
cGMP
Drug Products & APIs

Objectives (If applicable):
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

Target Audience (If applicable):
• Manufacturing/production personnel
• R&D laboratory personnel
• Scientists and researchers
• Batch record reviewers
• QA/QC specialists
• Validation specialists
• Quality assurance auditors