It is the aim of this Live Online Training to provide information on the characterisation, use and maintenance of analytical Reference Substances.
You will get to know
how to correctly use Pharmacopoeial CRSs,
which compendial and regulatory requirements have to be considered,
how to characterise reference standards,
what GMP inspectors expect when visiting your quality control lab,
how to assign the content for CRSs.
Finally, you will get recommendations on how to prepare for an audit in the QC lab with focus on reference material.
Background
The establishment, handling and use of reference standards is a key issue for analysts in every quality control laboratory in the pharmaceutical and API industry. The ability to demonstrate compliance of pharmaceutical products with the original licence approval conditions depends on the accuracy of the analytical results. Therefore, the integrity of the reference material is pivotal to the consistency of all analytical determinations.
The application of reference standards is provided for in many monographs of the various pharmacopoeias (Ph.Eur., USP, BP, JP, etc.) as well as in internal test procedures for finished products.
Target Group
This Live Online Training is designed for Analysts, Laboratory Managers, Laboratory Scientists, QC/QA Managers, Qualified Persons and will also be of significant interest to Regulatory Affairs Professionals and organisations providing a regulated contract laboratory service.
Technical Requirements
We use WebEx 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