Target Lab Compliance - PHARMALAB on 10-11 November, 2015, Swissotel Congress Centrum, Düsseldorf / Neuss

For the third time already PharmaLab picks up the latest regulatory and scientific changes and developments in all laboratory areas of the pharmaceutical industry. International and national analytical, bioanalytical and microbiology conferences provide a selection of top-class lectures. In addition PharmaLab is accompanied by an exhibition, in which suppliers of laboratory materials, equipment as well as contract laboratories present their current products and method developments as services.

Currently the European Pharmacopoeia Chapters 2.6.30 (Monocyte Activation Test), 2.6.8 (Pyrogens) and 5.1.10 (Guidelines for using the Test for Bacterial Endotoxins) are under revision. Naturally, a conference will pick up these developments and deal again with the test for Endotoxins and Pyrogens.

A subject that has not lost any relevance is the masking of endotoxins and Low Endotoxin Recovery (LER) and the current strategies to deal with this effect – reason enough to dedicate some special attention to this subject.

Pharmeuropa recently issued the draft of the revised Ph.Eur. Chapter 5.1.1 on "Modern Microbiological Methods". New at PharmaLab is therefore the Rapid Microbiological Methods Conference, providing first-hand information on the state of the revision and the revised requirements.

Another challenge in the field of microbiological testing is the evidence of so-called adventitious agents such as Mycoplasma and Viruses. A further "newcomer" will hence cover the authorities’ requirements on the one hand and the currently available detection methods on the other.

A session on the validation of bioanalytical methods with statistical means will specifically deal with the type of studies that are needed. It will also concentrate on the statistical analyses that are necessary for the calculation of the bioactivity and which provide clues for the assessment of the validation parameters.

A known conference subject is "Laboratory Informatics" where relevant systems such as LIMS or ELNs will be discussed. In the centre will be laboratory data systems and how they can be implemented in today's QC and R & D environments as well as the integrity of the data produced in the lab.

The most recent regulatory developments and compliance aspects will be the focus of the eponymous conference "cGMP compliance trends in analytical quality control".

In addition to these conferences national sessions will provide comprehensive updates on Bioanalytics, Leachables and Extractables, Lab Optimisation and Pharmaceutical Analytics.

Laboratory compliance is a vast field providing plenty of subjects we could have chosen for PharmaLab 2015. We are certain we picked those subjects that are most up-to-date and are highly relevant in your day-to-day business. Together with the exhibition specifically designed for all suppliers in the laboratory environment PharmaLab 2015 will provide you again with a valuable learning and networking experience. We look forward to seeing you there.

Highlights

- 10 November Prof Dr Jack Levin: The LAL Test for Bacterial Endotoxins: Discovery, Development and Applications.
- 11 November Frans Maris: Regulations on Heavy Metals: Update on the status of USP, FDA and ICH Guidelines and path forward at MSD.