Good Documentation Practice in the GMP Environment

Days

Hours

Minutes

Seconds

This course includes:

Collaborative environment that
encourages interaction
Case studies and Q&A sessions
Training materials
Tools and techniques to apply
immediately in your role
Recording access
Certificate of completion

Are you ready to ensure your documentation practices are not just compliant but exemplary? In the high-stakes world of pharmaceuticals, every piece of documentation must guarantee integrity, accuracy, and reliability. This masterclass offers a roadmap to mastering Good Documentation Practice (GDocP) in the GMP environment, providing actionable insights and tools to enhance your processes and meet regulatory standards.

Course Overview

Good documentation is more than a regulatory requirement, it’s the cornerstone of product safety, quality, and efficacy. This masterclass dives deep into the EU GMP guidelines, Pharmacopoeia provisions, and global data integrity standards, showing you how to align documentation with best practices.

Picture this: Documents that seamlessly pass audits, data that tells a reliable story, and processes that boost both confidence and compliance. Through interactive modules, practical demonstrations, and expert guidance, this course will transform the way you approach documentation in the GMP environment.

What You’ll Gain

Master Regulatory Requirements
Gain an in-depth understanding of GMP-compliant documentation, from types of documents to data integrity requirements and Pharmacopoeia standards. By the end, you'll feel equipped to tackle audits and regulatory reviews with confidence.
Elevate Your Data Presentation
Learn how to convert raw data into meaningful insights using mathematical-statistical methods, proper reporting formats, and data visualization techniques. Whether it’s tabular presentations or derived data, your documentation will exude professionalism and clarity.
Drive Compliance Across Complex Processes
Navigate challenges like site transfers, cross-validations, and analytical data assessments with ease. With a focus on CMC data, statistical analysis, and descriptive reporting, you’ll develop the skills to manage even the most complex documentation tasks.

Why This Masterclass?

Learn from a Trainer Who Inspires Confidence
What makes a great trainer? According to previous participants, it’s the ability to simplify the complex, connect meaningfully, and deliver insights you can use immediately. Dr. Markus Veit excels in all these areas.
- The speaker has deep knowledge, and his presentations are easy to follow.”
- “Brilliant competence of trainer.”
Every session is designed to leave you feeling informed, confident, and ready to tackle GMP documentation challenges.
Get Practical, Real-World Insights
Theory alone won’t help you pass audits or ensure compliance. That’s why this masterclass is packed with actionable content that bridges the gap between knowledge and implementation. Participants agree:
- “Practical examples and helpful overviews of best-case scenarios.”
- “A lot of useful information and document references.”
You’ll gain tools, strategies, and insights that you can apply directly to your work.
Dive into Comprehensive, Engaging Content
Imagine training that’s not only thorough but also captivating. That’s the standard here. From well- paced presentations to detailed explanations, every moment is carefully crafted for maximum impact. As one participant noted:
- “The contents, presentation, and tempo were perfect.”
- “Very global overview with references to multiple guidelines.”
Whether it’s the depth of content, the clarity of delivery, or the actionable nature of the materials, this course is designed to meet your expectations—and exceed them.

Agenda Highlights

Day 1: Fundamentals of GMP Documentation

Day 2: Advanced Topics and Practical Applications

Who Should Attend

Pharmaceutical Development Teams
Quality Assurance and Quality Control Professionals
Regulatory Affairs Specialists
Validation and Analytical Scientists
Anyone involved in GMP-related documentation processes

About Trainer

Prof. Dr. Markus Veit brings over two decades of leadership in the pharmaceutical industry. As Managing Director of ALPHA-TOPICS GmbH, his expertise spans pharmaceutical analysis, validation, and regulatory affairs.

Member of the German Pharmacopeial Expert Committee at BfArM.
Specialist in pharmaceutical development and testing.
Trainer and educator with years of experience designing practical courses for industry professionals.

Dr. Veit’s ability to distill complex regulations into actionable strategies makes him the ideal guide for this masterclass.