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good documentation practices and data integrity

Good Documentation Practice (GDP) is a fundamental component of quality management systems in regulated industries such as pharmaceuticals, biotechnology, medical devices, and food manufacturing. It ensures that all records are accurate, complete, legible, traceable, and reliable throughout their lifecycle. The course introduces GDP principles, documentation requirements, regulatory expectations, data integrity concepts, common documentation errors, and best practices for maintaining compliant documentation systems in both paper-based and electronic environments

4 hr

Created by Dr. YASSER MEKKY

EN/AR [Auto]

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# Content
1 • Regulatory overview and GEP application process.
2 • Mapping and legal considerations.
3 • Geology and reservoir characterization.
4 • Development and production planning.
5 • Documentation including maps, geological discussions, production histories.
6 • Regulatory amendments and exemptions for specific zones.
# Outcomes
• Explain the role of GDP in pharmaceutical quality systems.
• Demonstrate correct documentation practices according to ALCOA+ principles.
• Complete documentation accurately, legibly, contemporaneously, and traceably.
• Manage SOPs, Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), logbooks, and equipment records in compliance with GMP.
• Identify documentation deficiencies and recommend corrective actions.
• Apply documentation requirements to electronic record systems and data integrity controls.
• Participate effectively in audits and regulatory inspections involving documentation.
• Promote a culture of documentation accuracy and quality compliance.
# Participants
1
P
Potential participants would be reservoir engineers, well planners, environmental specialists, and regulatory officers involved in well location planning and resource development.