It is the aim of this course to address all those GMP Compliance issues that are currently discussed as hot topics in analytical quality control laboratories and during GMP-/FDA-Inspections. This course will give an update about the actual regulatory requirements (EU, US, WHO, etc.) and will show how these requirements can be put into practice. In addition this course will look at scientific and regulatory trends to be expected in the future.
Due to changing regulatory requirements pharmaceutical quality control units are continuously facing new challenges. There are many regulatory requirements relevant for the pharmaceutical quality control, both in EU and in the US, for instance EU GMP Guide, 21 CFR Part 210/211 (USA), EMA and FDA Guidances, WHO Recommendations and Pharmacopoeias (Ph.Eur., USP, JP).
Laboratory Managers and Analytical Scientists must be familiar with all these GMP-related topics and must be aware of the latest updates and the current interpretation of all these guidance documents.
In addition, analytical QC laboratories are increasingly in the focus of GMP inspections, both in Europe and in the US. For instance after FDA inspections, many laboratory-specific citations can be found in 483s and Warning Letters. And many findings related to the laboratory can also be found after inspections of European GMP supervisory authorities.
Potentially interested topics could be (Case studies about the practical implementation preferred):
- New EU GMP Requirements of Chapter 5 and 6 for the Analytical Lab
- Hot topics in GMP Compliance Inspections in Analytical Labs (EU / U.S.)
- Statistical Sampling Plans: now required according to new EU GMP Chapter 5?
- Handling of OOT Results as new requirement in EU GMP Chapter 6 – how to realize in practice?
- Cleaning Validation for Analytical Equipment – what are the regulatory expectations today?
- Optimization of Sampling Plans and Testing Plans in Compliance with New EU GMP Chapter 5 for APIs/Excipients
- Future USP Expectation: Lifecycle Management for Analytical Methods
(Including Impact on Changes/Variations)
- ObD for Analytical Methods - Challenges and Benefits
This conference will be of significant value to
from quality control units in the pharmaceutical industry (routine QC and in research and development) who are responsible for GMP Compliance in the analytical laboratory. This course is also intended for employees in Quality Assurance and from contract labs.
- Laboratory managers
- Quality control managers
Qualified Persons (QPs)
- Analytical scientists
- Senior laboratory staff