Document Control & Good Documentation Practices (GDP) in GMP

Descripción

This course provides a clear and practical understanding of document control and Good Documentation Practices (GDP) within a cGMP-regulated pharmaceutical and biotech setting. You will learn how to create, review, approve, distribute, and archive controlled documents, while ensuring compliance with key global regulations such as FDA 21 CFR Part 211, EU GMP Annex 11, and ICH Q10. Mastering documentation and record control is essential for maintaining an effective Quality Management System (QMS). Proper documentation serves as both guidance for performing tasks and evidence that processes have been carried out correctly. In a regulated environment, accurate and traceable records are not only a legal requirement but also the foundation of product quality and patient safety. By the end of this course, you will be able to: • Understand the purpose and scope of document control systems. • Apply Good Documentation Practices (ALCOA+ principles, data integrity). • Manage controlled documents such as SOPs, batch records, protocols, and reports. • Implement change control and periodic review of documents. • Prepare for regulatory inspections and understand auditor expectations. Target Audience • QA & QC professionals in pharma and biotech. • Production and R&D staff working under GMP conditions. • Regulatory Affairs specialists. • Students and professionals preparing for careers in GMP compliance. • Anyone who needs to understand how documentation supports GMP compliance and contributes to regulatory success. This course combines theory with practical examples, case studies, and real audit findings, making it suitable both for beginners and experienced professionals seeking to strengthen their compliance knowledge.

Lo que aprenderás

• How to write, review and control GMP documents the right way
• What ALCOA+ actually means — and how to use it every day.
• The most common documentation mistakes (and how to avoid them!)
• How document versioning, approvals, and archiving work in a real GMP environment
• Why GDP is the foundation of data integrity and compliance

Requisitos

• Not really! You don’t need to be an expert
• If you’ve ever worked in a lab, QA, QC, or production — great, you’ll recognize a lot of examples
• If not — don’t worry. We’ll start from scratch and make everything super clear