Reference Standards - Live Online Training Establishment, Use and Maintenance of Analytical Reference Substances

Tuesday, 12 March 2024 9 .00 - 16.45 h

Course No 20917

All times mentioned are CET.

Our Service

Costs

*ECA-Member:**	EUR 990,--
*Regular Fee:**	EUR 1190,--
*EU/GMP Inspectorates:**	EUR 595,--
*APIC Member Discount:**	EUR 1090,--

(All prices excl. VAT). Important notes on sales tax.

Registration

* also payable by credit card

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Heiko Brunner, Hamburg, Germany
Dr Joachim Ermer, Ermer Quality Consulting, Germany
Dr Rainer Gnibl, GMP Inspector for EMA and local Government, Germany
Dr Ulrich Rose, Former Deputy Head of the European Pharmacopoeia Department, EDQM, France

Objectives

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.

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

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