This Live Online Training will give a comprehensive overview of the main GMP requirements for Quality Control Laboratories, from a European as well as from the U.S. (FDA) perspective. It is the aim of the training to address the challenges that QC Compliance Managers face today regarding the relevant regulatory requirements and how to successfully implement these requirements in the analytical lab
Background
Due to changing regulatory requirements pharmaceutical Quality Control Compliance Managers are continuously facing new challenges. There are many regulatory requirements relevant for the pharmaceutical quality control, both in EU and in the U.S., for instance:
EU GMP Guide (Part 1 / Part 2 / Annexes)
21 CFR Part 210/211 (USA)
Guidances (EMA and FDA)
ICH Guidelines
WHO and PIC/S Recommendations
Pharmacopoeias (Ph.Eur., USP)
QC Compliance Managers need to be familiar with all these GMP-related topics and need to 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 U.S. 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. Key compliance requirements include:
Change control Systems
Calibration and qualification of analytical Instrument
Reference Standards
GMP compliant documentation
Validation of analytical methods
Stability program
Laboratory Data Integrity
Procedures for handling OOS results
All these key compliance issues will be addressed in this Live Online Training. A set of live Q&A sessions will give you the possibility to interact with the speakers and get answers to your Questions.
Please note that the emphasis of this training is on small-molecule pharmaceuticals. The course will not focus on biotech products.
Target Group
This Live Online Training will be of significant value to
Laboratory managers
Quality control managers
Analytical scientists
Senior laboratory staff
from Quality Control units in the pharmaceutical industry who are responsible for GMP Compliance in the Analytical Laboratory.
Technical Requirements
We use WebEx Events for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Testimonials
Seminar Programme as PDF