Dr. Ulrich Rose
Straßburg
Referent:innen
Dr. Joachim Ermer
Ermer Quality Consulting
Dr. Heiko Brunner
Hamburg
Dr Rainer Gnibl
GMP Inspector
All times mentioned are CET.
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 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.
Programm
Gesamtes Programm als PDF herunterladen
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
| ECA-Member*: | € 1190,- |
| Regular Fee*: | € 1290,- |
| EU/GMP Inspectorates*: | € 645,- |
| APIC Member Discount*: | € 1240,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Seminarprogramm als PDF
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