This 4-hour course introduces participants to modern Good Documentation Practices and GMP data integrity expectations for paper, hybrid, and electronic GMP records.
The course connects everyday documentation behaviors to GMP requirements, including 21 CFR Part 211, 21 CFR Part 11, FDA’s data integrity guidance, MHRA GxP data integrity expectations, and PIC/S guidance on data management and integrity. FDA states that data integrity is part of CGMP expectations for drugs, and Part 11 applies to certain electronic records and electronic signatures used to meet FDA record requirements.
- Pharmaceutical Production Associates
- Production Managers
- Quality Managers
- Management
- Any employee who writes, edits, or compiles documents used in manufacturing FDA regulated products
- Distinguish documents from records
- Recognize common documentation errors
- Apply ALCOA+ principles
- Understand the role of metadata and audit trails
- Identify practical controls for electronic records, spreadsheets, and computerized systems
By the end of the course, students will be able to:
- Distinguish between GMP documents, records, raw data, metadata, copies, and true copies.
- Explain why documentation and data integrity are essential to product quality, patient safety, and regulatory compliance.
- Apply core Good Documentation Practices to paper, electronic, and hybrid records.
- Identify common documentation errors and determine appropriate correction practices.
- Explain ALCOA+ principles: attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available.
- Recognize how 21 CFR Part 11 affects electronic records and electronic signatures.
- Describe the risks associated with uncontrolled spreadsheets used for GMP calculations, tracking, or recordkeeping.
- Identify basic expectations for audit trails, user access, data review, system controls, and data governance.
- Recognize behaviors and system weaknesses that can create data integrity risk.
- Practice reviewing documentation examples for completeness, clarity, traceability, and compliance.
Delivered in-person in a classroom or lab setting.
A combination of online and in-person components.
Delivered online with a live instructor at a scheduled date and time.
This 4-hour course introduces participants to modern Good Documentation Practices and GMP data integrity expectations for paper, hybrid, and electronic GMP records.
The course connects everyday documentation behaviors to GMP requirements, including 21 CFR Part 211, 21 CFR Part 11, FDA’s data integrity guidance, MHRA GxP data integrity expectations, and PIC/S guidance on data management and integrity. FDA states that data integrity is part of CGMP expectations for drugs, and Part 11 applies to certain electronic records and electronic signatures used to meet FDA record requirements.
- Pharmaceutical Production Associates
- Production Managers
- Quality Managers
- Management
- Any employee who writes, edits, or compiles documents used in manufacturing FDA regulated products
- Distinguish documents from records
- Recognize common documentation errors
- Apply ALCOA+ principles
- Understand the role of metadata and audit trails
- Identify practical controls for electronic records, spreadsheets, and computerized systems
By the end of the course, students will be able to:
- Distinguish between GMP documents, records, raw data, metadata, copies, and true copies.
- Explain why documentation and data integrity are essential to product quality, patient safety, and regulatory compliance.
- Apply core Good Documentation Practices to paper, electronic, and hybrid records.
- Identify common documentation errors and determine appropriate correction practices.
- Explain ALCOA+ principles: attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available.
- Recognize how 21 CFR Part 11 affects electronic records and electronic signatures.
- Describe the risks associated with uncontrolled spreadsheets used for GMP calculations, tracking, or recordkeeping.
- Identify basic expectations for audit trails, user access, data review, system controls, and data governance.
- Recognize behaviors and system weaknesses that can create data integrity risk.
- Practice reviewing documentation examples for completeness, clarity, traceability, and compliance.
Delivered in-person in a classroom or lab setting.
A combination of online and in-person components.
Delivered online with a live instructor at a scheduled date and time.