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 Details:
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration: When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate: The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Programme
Reference Substances of the European Pharmacopoeia – Establishment and Use
Definition of primary and secondary Standards
Analytical techniques and methods used for the Establishment
CRSs for identification Tests
Impurities and impurity mixtures as CRSs
Assay Standards
Collaborative Trials
Correct use of Pharmacopoeial CRSs
Storage, manufacture and distribution of CRSs
Qualification, Management, and Use of Reference Standards in Quality Control
Types of reference Standards
Certificates and documentation
Appropriate use of reference standards
Requirements for commercial reference standards
Reference Standards – GMP Inspector’s Perspective
Legal requirements in EU
How to characterize & qualify standards?
What is expected in EU-GMP inspection?
Frequent findings
Uncertainty in Content Assignment of Reference Standards
Measurement uncertainty
Mass balance approach or assay vs. primary standards?
To change or not to change – ensuring reference standard stability
Reference Standards – a Laboratory View
Ordering – where to get them?
Shipment and storage
Handling and documentation
Audit findings
Optimizing reference standard consumption
Recording from 12 March 2024
Duration of Recording: 4h 42min
This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager" Learn more
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