PharmaLab Congress 2022 - 1st day and 2nd day Congress & Exhibition - The Event for all pharmaceutical laboratory areas

PharmaLab Congress 2022 - 1st day and 2nd day

Neuss, Germany

Course No 20308

 

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Objectives

After two years in online mode, from 21-23 November 2022, the 10th PharmaLab Congress will again take place on-site in Düsseldorf/ Neuss. The congress, which is aimed at employees and managers in all laboratory areas of the pharmaceutical industry, is composed of a pre-conference workshop, 5 international conferences and a German-language conference as well as the accompanying exhibition. It will provide information on the latest developments in laboratory methods, materials and the current status of regulatory requirements of pharmacopoeias and guidelines. In addition, experts from authorities, industrial quality control and contract laboratories will present their experiences with the use and qualification of analytical systems as well as with the validation of analytical methods and microbiological tests. Take advantage of this unique opportunity to learn about the state of the art in pharmaceutical laboratories and 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 of biological origin, classical analytical and testing methods are not suitable. Newly developed methods like MAT for pyrogen tests, rapid methods for sterility tests or necessary bioassays for cell based and gene therapy products require a permanent knowledge update and training of the laboratory personnel and the involved staff. This conference is of interest to:
  • Laboratory managers, supervisors and analysts in pharmaceutical quality control departments
  • Laboratory personnel in research and developments
  • Responsible authoritiess
  • Laboratory supplierss
  • Staff of contract laboratoriess
  • QC responsible staffs

Programme

The conferences

21 November 2022 - Pre-Conference

  • 3rd International Mycoplasma qPCR Testing User Day

22 November 2022

  • ECA – Analytical Procedure Life Cycle Management - ICH Q14/ICH Q2(R2)
  • ECA – Endotoxin and Pyrogen Testing (Tag 1)
  • ECA – Alternative and Rapid Microbiological Methods (Tag 1)
  • ECA – Cells, Tissues and ATMP – Quality Control (Tag 1)

23 November 2022

  • ECA – Laboratory Optimization, Automation and Digitalization
  • ECA – Endotoxin and Pyrogen Testing (Tag 2)
  • ECA – Cells, Tissues and ATMP and Alternative Microbiological Methods (Tag 2)

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