PharmaLab 2015 - Day 1

PharmaLab 2015 - Day 1

Düsseldorf/Neuss, Germany

Course No 9384


Costs

This conference already took place.

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

Objectives

On 10 and 11 November 2015 the PharmaLab Congress will take place in Düsseldorf/
Neuss for the third time. This Congress addressing staff and executives in all lab areas
of the pharmaceutical industry will be comprised of six international and four German
language conferences plus the parallel exhibition. It will provide you with current
developments of laboratory methods, materials as well as the current status of
the regulatory requirements of the Pharmacopoeias.
Furthermore, experts from authorities, industrial quality control and contract laboratories
will share their experience with the use and the qualification of analytical systems
as well with the validation of analytical methods and microbiological tests.
Use this unique opportunity to get an update on the state of the art in pharmaceutical
laboratories and to discuss current developments with speakers and colleagues

Background

Laboratory work is an important part of pharmaceutical research, development and
quality control. During inspections the responsible authorities significantly increased
their emphasis on the quality management and performance of laboratories and
their quality standards. This scrutiny of the regulators require laboratories to establish
GLP and GMP appropriate systems and methods, and in particular:
.. General GLP or cGMP understanding and particularly relating to compliance with
written procedures
.. Validation, performance and transfer of analytical procedures and microbial tests
.. Equipment qualification and calibration
.. Computer validation (including the requirements and actual interpretation of
EU GMP Annex 11)
.. Operator training
Especially for pharmaceutical products and active substances from biological origin,
classic analytical and testing methods don’t fit. New developed methods e.g. MAT
for pyrogen testing, rapid methods for sterility testing or necessary bioassays require
a permanent knowledge update and advanced training of laboratory personnel and
of the involved staff.

Target Group

This conference will be of interest to
.. Laboratory Managers, Supervisors and Analysts in pharmaceutical quality control
departments
.. Laboratory Staff of Research and Development
.. Responsible Authorities
.. Suppliers on Laboratories
.. Associates of Contract Laboratories

Programme

The Conferences

10 November 2015
ECA Laboratory Informatics ¡V Update 2015
ECA Rapid Microbiological Methods

11 November 2015
ECA ¡V cGMP Compliance Trends in Analytical Quality Control
ECA Validation Approach of Bioassays Using Statistical Methods
ECA Endotoxin and Pyrogen Testing (Day 2)
ECA Adventitious Agents - Impurities and Contaminants

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