Dr Ulrich Rose
Straßburg
Referierende
Dr Joachim Ermer
Ermer Quality Consulting
Dr Heiko Brunner
Hamburg
Dr Rainer Gnibl
GMP Inspector
Zielgruppe
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.
Zielsetzung
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
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.
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.
Programm
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
Weitere Informationen
To participate in an on demand training course, 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 you can decide at what date you want to follow the training course online. Starting with the access date you entered in the registration process the stream will be available to you for 7 days. Within in this period 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.
Contacts:
Questions regarding content:
Dr Christian Arndt, +49 62 21 84 44-14, arndt@concept-heidelberg.de
Questions regarding organisation:
Mr Maximillian Bauer, +49 62 21 84 44-25, bauer@concept-heidelberg.de
Recording from 3 September 2026
Duration of Recording: 5h 42m
Teilnahmegebühr
| ECA-Member*: | € 1090,- |
| Regular Fee*: | € 1290,- |
| EU/GMP Inspectorates*: | € 645,- |
| APIC Member Discount*: | € 1190,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager"
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E-Mail: info@concept-heidelberg.de
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