Quality Risk Management in the EU: Concepts and Compliance
Are you in the process of establishing or refreshing a robust risk management system for regulatory compliance in the EU?
In this newly published report, Quality Risk Management in the EU: Concepts and Compliance, GMP compliance experts Petra Rempe and Martin Mayer will share how to initiate a quality risk management process for your drug … from development to distribution to surveillance. You’ll gain essential insights into risk control, reduction and acceptance. The report also covers ICH guidelines and EU regulations applicable to quality risk management.
Get this new simple-to-follow management report detailing the regulatory expectations and implementation guidelines necessary to manage quality risk in the EU. With expert tips, comprehensive explanations, illustrative diagrams and graphs, you’ll find the best path for controlling risk in pharmaceutical manufacturing.
Key management report takeaways:
- The Quality Risk Management Process
- Prerequisites for quality risk management
- How to apply quality risk management to a product’s lifecycle
- Where quality risk management falls within a quality management system
- Ways to initiate a quality risk management process
- The definition of risk control, reduction and acceptance
- Risk monitoring activities
- How to apply ICH guidelines
- Meeting EU regulation requirements
Meeting regulatory requirements in the EU means understanding all the risks that can arise during your product’s creation and management. Our experts will guide you in that process.
Order your copy today.
About the Contributors
Petra Rempe has been a Good Manufacturing Practice Inspector in the administrative district of Münster, Germany, since 1998. She is responsible for monitoring pharmaceutical companies, wholesalers, manufacturers and importers of pharmaceuticals, including blood products, tissues preparations and active ingredients. She is qualified as a specialist pharmacist in pharmaceutical technology and public health.
Martin Mayer is the Vice President of Quality Assurance at Fresenius Kabi Deutschland. He has been responsible for managing the quality organizations of the Global Operations Generic Drugs & Standard Solutions production sites since 2013 and is an expert in quality management standards, GMP compliance, inspection management and risk management.
Who Will Benefit
- Drugmakers operating in the EU
- Biologics companies operating in the EU
- Contract manufacturers
- API manufacturers
- Quality professionals
- Regulatory affairs professionals
- Executive-level professionals
Add to Cart
Petra Rempe and Martin Mayer
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Books Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.
Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.