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Reference Standards
18-19 November 200
Berlin, Germany
Please click here to view the program of this conference or course
To book for this program, just click on the option:
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At this conference we offer a Conference Exhibition.
Please click here in order to view the registration form (PDF) for exhibitors.
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Objectives
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 because 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 objectives of this conference are to provide information on
- Establishment, maintenance, use and administration of primary and secondary reference standards to assure GMP-compliance
- What characterisation of a primary reference standard really entails
- The importance of measurement uncertainty
- The characterisation, establishment, maintenance and distribution of reference standards from the perspective of the European Pharmacopoeia (EP CRSs) and the United States Pharmacopoeia (USP RSs)
- Equipment qualification and calibration
- Reference Standards for herbals from the pharmacopoeial and industry perspective
- Reference materials for biotechnology derived products
- Identification of impurities in reference material via HPLC
- Audits and inspections in analytical quality control laboratories with respect to reference materials
The course programme is rounded of by a panel discussion about pharmacopoeial reference materials.
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