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

Reference Standards - Live Online Training

Course No 19362

All times mentioned are CEST.

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Speakers

Dr Joachim Ermer, Ermer Quality Consulting, Germany
Dr Rainer Gnibl, GMP Inspector for EMA and local Government, Germany
Jürgen Martin, Martin Consulting, 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

For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer 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

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

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