GDocP Mastery – Writing, Recording, and Reviewing to GMP Standards
Documentation is the foundation of GMP — not just to record compliance, but to prove it. Yet GDocP failures remain among the most frequent inspection observations from MHRA, FDA, EMA, and WHO. This course helps your team close that gap.
This 4-hour instructor-led course equips GMP personnel with the practical skills, regulatory principles, and cultural mindset to apply Good Documentation Practice (GDocP) across all departments, systems, and formats — from paper batch records to electronic logs and hybrid setups.
Course Details
Instructor
Paul Palmer
Level
Beginner
Duration
3.5 Hours
Type
Instructor led
Course Content
Why is this course essential?
Deviation and CAPA failures are consistently among the top inspection findings. Weak investigations, repeat errors, and vague or generic CAPAs damage both inspection confidence and internal performance.
This course provides practical, structured tools to help GMP teams avoid those pitfalls — and instead, create a deviation management system that drives improvement and stands up under regulatory scrutiny.
What does the course cover?
-
- Regulatory foundations:
- EU GMP Chapter 4
- Annex 11 (Electronic Records)
- FDA Data Integrity Guidance
- PIC/S PI-041 Aide Memoire
- ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available
- Common GDocP errors and how to prevent them:
- Backdating
- Unexplained gaps or missing signatures
- Incorrect corrections
- Unapproved abbreviations
- Documentation not linked to batch
- Practical techniques:
- Correcting errors without obscuring data
- Recording real-time entries
- Reviewing batch records and cleaning logs
- Writing audit-ready documentation
- Linking documentation quality to QP certification
- GDocP in electronic and hybrid systems:
- Audit trail review
- Controlled access
- Role-based signatures
- Spreadsheet controls
- System validation and SOP alignment
- GDocP-related deviation investigation and CAPA
- Documentation training, SOP alignment and culture building
- Real-world inspection examples, audit findings, and case studies
- Regulatory foundations:
Ideal for?
- QA deviation reviewers and CAPA owners
- Qualified Persons (QPs)
- Production and operations managers
- GMP trainers and investigators
- Documentation and compliance leads
- Quality system and QMR facilitators
Benefits:
- Reduces GDocP-related audit findings and batch release delays
- Enhances data integrity and QP confidence in certification
- Includes SOP alignment checklist, GDocP error correction guide, and review templates
- Builds a culture where documentation is respected and reinforced
Keywords: GDocP training, good documentation practice course, ALCOA+ GMP, GMP documentation review, EU GMP Chapter 4, FDA data integrity training, batch record review SOP, hybrid system documentation, GMP paper records, QP batch release training
What's Included
3.5Hrs of instructor led learning
Usable documents and templates
Real work examples and exercises
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