PharmaLab 2019 - 1st day

12 November 2019, Düsseldorf/Neuss, Germany

Course No. 17475

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Objectives

From 11 to 13 November 2019 the PharmaLab Congress 2019 will take place in Düsseldorf/Neuss for the seventh time. This Congress addressing staff and executives in all lab areas of the pharmaceutical in-dustry will be comprised of one pre-conference workshop, eight international and two German language conference plus the parallel exhibition. It will provide you with current developments of labora-tory 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 as 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 qualitycontrol. During inspections the responsible authorities significantly increased their emphasison the quality management and performance of laboratories and their quality standards. Thisscrutiny of the regulators require laboratories to establish GLP and GMP appropriate systemsand 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
  • Validation of analytical methods according to the new USP Lifecycle Model, in particular after the ICH Press Release to update ICH Q2 (R1)
  • Computer validation (including the interpretation of EU GMP Annex 11 and 21 CFR Part 11 and the actual requirements for lab data integrity)
  • Operator training

Target Group

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 train-ing of laboratory personnel and of the involved staff.



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.



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



12 November 2019


  • ECA - Rapid Microbiological Methods

  • ECA - Analytical Procedure Lifecycle Management / Revisions to ICH Q2 & the proposed Q14 (Day 1)

  • ECA - Endotoxin and Pyrogen Testing (Day 1)

  • ECA - Bioanalytics and Bioassays - Challenges for Biological Drug Substances and Products


13 November 2019


  • ECA - Microbiological Real Time Counting and Testing

  • ECA - Analytical Procedure Lifecycle Management

  • / Revisions to ICH Q2 & the proposed Q14 (Day 2)
  • ECA - Endotoxin and Pyrogen Testing (Day 2)

  • ECA - Testing and Analytics of Cells, Tissues and ATMP

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Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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