EU-GMP for the Experienced
Learn about the specialized EU GMP requirements
Build on your foundational knowledge of GMP with this course, which gives you the opportunity to delve into more specialized topics within the EU GMP regulations.
GMP in Pharmaceutical Construction
Design pharmaceutical facilities and areas with GMP in mind from the very first design step
Learn the essential regulatory knowledge you need to design or renovate areas within pharmaceutical facilities. Understand key design requirements early on and reduce the risk of redesigns, delays, and compliance issues.
Design and Implementation of a Quality Management System (QMS)
Learn how to build a compliant and user-friendly QMS using practical tools
Gain insight into the regulatory requirements for quality management systems for pharmaceuticals, medical devices, and combination products, and learn about practical examples of quality management systems in organizations of various sizes and levels of complexity.
EU-GMP for the Experienced
Learn about the specialized EU GMP requirements
Build on your foundational knowledge of GMP with this course, which gives you the opportunity to delve into more specialized topics within the EU GMP regulations.
Ready for Inspection|company
Be Ready for Your Next Regulatory Inspection
Understand the requirements, roles, and appropriate conduct before, during, and after an inspection. Employees receive practical advice to help your company interact with the inspector in a calm, knowledgeable, and professional manner.
Ready for Inspection | Company
Get Ready for the Next Regulatory Inspection
Get a handle on the requirements, roles, and best practices before, during, and after an inspection. Employees will receive specific guidance so that you can meet with the inspector calmly, competently, and professionally.
Update to Annex 11, Chapter 4, and new Annex 22
Understand the implications so you're ready when the changes take effect
Spend a day with an expert from one of the EU’s working groups on data integrity and gain insight into the rationale behind the proposed changes.
From Compliance to a Culture of Quality
When Quality Goes Beyond Compliance
You’ll learn how to implement GMP so that you not only meet the requirements but also actively contribute to a strong quality culture that enhances patient safety, data integrity, and collaboration.
Control of GMP Documentation
Good Documentation Practices: Clear, Accurate, and Traceable
Documentation is a key element of GMP and crucial for patient safety.
It’s rarely major errors that cause problems. Often, it’s the small details in the documentation.
Get a handle on good documentation practices and avoid mistakes in your day-to-day work.
Navigating Drug–Device Combination Products (CPs)
Cross-functional Development and Lifecycle Management of CPs: Assessing Risks and Interfaces
Learn how drug and device components come together throughout development, approval, and lifecycle management. Focus on risks, interfaces, and practical cross-functional challenges (i.e., EDDOs), with clear examples based on EU and U.S. regulatory requirements.