PharmaLab 2018

Date: 20 November 2018 - 21 November 2018

Location:
Crowne Plaze Düsseldorf – Neuss
Rheinallee 1
Neuss
41460
Germany

PharmaLab focuses on the key questions concerning QC and QA professionals in analytics, bio analytics and microbiology. And this year the meeting and exhibition put the regulatory challenges and their impact on pharmaceutical and biopharmaceutical quality labs in the spotlight.

In recent months, there have been a number of changes in the relevant authority guides and chapters of the pharmacopoeias in Europe and in the US, as, e.g., the draft Annex 1 of the EU GMP Guideline with an increased focus on Quality Risk Management (QRM), a new stand-alone-guideline on GMP for ATMP and new drafts of the USP Packaging Chapters. Additionally, modern analytical as well as microbiological lab systems become more and more automated and computer based. These developments lead to new challenges – like qualifying such new systems and validating the methods or establishing Laboratory Integrated Management Systems (LIMS). And this, in turn, calls for compliance with the GMP Guide Annex 11, PIC/S Data Management and Integrity Practices and the latest FDA Data Integrity requirements.

Furthermore, the activities with regard to “low endotoxin recovery” as well as to the European initiatives to reduce necessary animal experiments in labs (3R ​​strategy), are still in the focus of biopharmaceutical companies, contract labs and authorities.

These issues build the core of eight international and four German-speaking conferences at PharmaLab, which also picks up a topic for the first time that’s often neglected somewhere between the responsibilities of QA, QC and manufacturing: pest control. Although many national and international regulatory guidelines ask for a conclusive concept of pest control for pharmaceutical and biopharmaceutical manufacturers, they do not provide details on what to do and how to do it. PharmaLab therefore wants to provide the platform for an information exchange and to discuss a structured cooperation of the parties involved.

For more information, please visit: PharmaLab 

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