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Maximising HPLC Productivity
21-23 April 2010,
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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Learning Goals
The purpose of this course is to provide attendees with practical information to manage HPLC within GMP-/FDA-regulated environments of the pharmaceutical industry by combining science and compliance. We want to ensure that participants can work compliantly as well as being able to improving productivity by using good science and business practices.
Background
High performance liquid chromatography is a key analytical technique used in nearly all analytical laboratories in the pharmaceutical industries. As such it is regulated with sections in all of the major pharmacopoeias (Ph.Eur. USP, etc.) as well as the subject of an FDA reviewer guidance document published in 1994.
This HPLC course will deal with all aspects for successful merging of science and compliance of HPLC to maximise productivity. The emphasis will be on the following science and compliance issues:
Miniaturisation of HPLC: advantages and disadvantages
Sampling practices and pitfalls
Sample preparation for HPLC
Latest enforcement issues and lessons for CDS
Science driven HPLC qualification
Method development and validation including understanding and trouble shooting problems
USP and EP system suitability tests
Practical chromatographic integration
Better working to avoid OOS investigations
Generating productivity gains through the validation of a CDS
Defining and protecting CDS electronic records
Documentation for HPLC
It is the aim of this course to provide guidance on ways of attaining best regulatory practice (GMP, FDA, pharmacopoeias, etc.) and to address tools to increase analytical HPLC labs’s efficiency and effectiveness.
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