Good Documentation Practices (GDP): A Hands-On Introduction

Overview:

This 1-day Good Documentation Practices (GDP) workshop equips participants with the practical documentation and data integrity skills required to work confidently in a GMP-regulated environment. Grounded in harmonised GDP principles, this full-day workshop bridges the gap between regulatory knowledge and day-to-day documentation practice. Through a combination of targeted instruction and hands-on activities, participants learn to write compliant SOPs, review and correct batch records, and execute documentation in real time.

What participants will learn

• Identify the key principles of GDP and their application

• Apply ALCOA+ principles to paper-based records and identify common data integrity violations

• Recognise and classify documentation error codes and apply GMP-compliant corrections

• Distinguish between the document types used in GMP/GDP settings (SOPs, batch records, logbooks, CoAs, deviations, and more)

• Understand the principles for drafting GMP-compliant documents

• Gain confidence in execution and review of manufacturing batch records through practical exercises

Ideal audience:

Ideal for anyone working in or transitioning into a GMP/GDP-regulated environment, including biomanufacturing operators, QA/QC staff, and production supervisors. No prior documentation training is required, though basic familiarity with GMP concepts is an asset. This course complements CASTL’s GMP Readiness Accelerator workshop and is designed to stand alone for open-enrolment participants.

Employer value:

For employers, this course addresses one of the most common sources of GMP non-conformances: documentation errors. Participants leave with immediately transferable skills in compliant record-keeping, SOP writing, and batch record execution hence reducing the risk of deviations, failed audits, and regulatory findings attributable to documentation gaps.