Documentation Management Training

Documentation Management Training

✅ Ensure Data Integrity. Enhance Compliance. Streamline Documentation Systems.

📘 Course Description

This specialized training provides a detailed understanding of documentation practices required for compliance in pharmaceutical manufacturing environments. It covers the lifecycle of GMP documents, control measures, data integrity requirements, and best practices to manage paper-based, hybrid, and electronic documentation systems.

Designed to meet FDA, EU GMP, ICH, and 21 CFR Part 11 expectations, this course empowers participants to design, implement, and maintain a robust documentation management system that supports product quality, traceability, and regulatory readiness.

🎯 Learning Objectives

·   Understand the regulatory framework for documentation in GMP-regulated environments.

·   Implement controls for document creation, approval, issuance, revision, archival, and retention.

·   Align documentation practices with ALCOA+ principles for data integrity.

·   Classify and manage various types of GMP documents (SOPs, BMRs, protocols, logs, etc.).

·   Integrate documentation management with QMS and electronic systems (DMS, EDMS).

·   Prepare documentation systems for regulatory inspections and audits.

📚 Course Syllabus

Module 1

Documentation in GMP

Module 2:

Document Lifecycle Management

·         Regulatory Requirements: 21 CFR Part 211, EU GMP, ICH Q10

·         Types of Documents: SOPs, Protocols, Forms, Logs, Reports

·         Hierarchy of Documentation

·         Creation, Review, and Approval Workflow

·         Version Control and Document Change Management

·         Issuance, Distribution, and Retrieval Processes

·         Archival, Retention, and Disposal Requirements

Module 3:

Data Integrity & ALCOA+

Module 4:

Electronic Documentation Systems

·         ALCOA+ Principles and Their Application

·         Good Documentation Practices (GDP)

·         Hybrid and Electronic Documentation (Part 11 Compliance)

·         Electronic Document Management Systems (EDMS)

·         Metadata and Audit Trails

·         Integration with QMS and Other GxP Systems

·         Case Studies and Common Pitfalls

📢 Register Now – Strengthen Documentation Practices for Inspection Readiness!