Dr. Ulrich Rose
Straßburg
Referent:innen
Dr. Joachim Ermer
Ermer Quality Consulting
Dr. Heiko Brunner
Hamburg
Dr. Rainer Gnibl
GMP Inspektor, Regierung von Oberbayern
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.
Hintergrund
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.
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.
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.
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 presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
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
Content Assignment for Chemical Reference Standards
- Measurement uncertainty
- Mass balance approach or assay vs. primary standards?
- To change or not to change – ensuring reference standard stability
Audits in Quality Control Laboratories focussing on Reference Materials
- Storage, labelling and expiry date of Reference Standards in the QC lab
- Documentation requirements
- Handling and use of Reference Standards in analytical test procedures
- Content of the Reference Standard SOP
- Preparing for an audit in QC labs
- Checklist for Reference Standard procedures
- Reference Material – Examples for non GMP compliance
Recording from 16 March 2023
Duration of Recording 4 h 51 min
| ECA-Member*: | € 890,- |
| Regular Fee*: | € 990,- |
| EU/GMP Inspectorates*: | € 495,- |
| APIC Member Discount*: | € 950,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen - das sagen andere über unsere Seminare:
