Seminar Nr. 15537
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Dr. Bernd Renger
Dr Renger is a Qualified Person and runs his own consultancy. Prior to that he was VP Quality Control at Vetter Pharma-Fertigung GmbH. He began his career at Hoechst AG in 1977 and has since held various management positions in the quality area at Mundipharma, Byk Gulden (today Takeda), as well as at Baxter BioScience AG in Vienna. Dr Renger was a member of the Board of the ECA Foundation and is a member the ECA Visual Inspection Group and the ECA Quality Control Group and Immediate Past Chair of the European QP Association.
The qualification of equipment is an essential requirement in the EU GMP Guide and in the revised Annex 15. Yet, compared to USP chapter <1058>, none of the two documents provide any details related to lab equipment. With the revision of Annex 15, the question arises whether Annex 15 also applies to laboratory equipment.
Addressed is laboratory personnel involved in qualification activities of laboratory equipment. Quality Assurance staff, who is interested in laboratory equipment qualification as well as - of course - manufacturers of laboratory equipment and service providers in the qualification of laboratory equipment are also addressed.
What are the requirements for the qualification of laboratory equipment in the EU?
Who is responsible for the qualification of laboratory equipment?
What delegation possibilities are available?
How to handle external service providers for the qualification of laboratory equipment?
- Is a contract needed?
Is the revised Annex 15 also valid for the qualification of laboratory equipment?
Are user requirement specifications/ functional specifications for laboratory equipment mandatory?
Are FAT/SAT required for laboratory equipment – and meaningful?
What does PQ mean regarding laboratory equipment?
Is the combination of qualification stages possible?
Conditional releases – are they also possible with laboratory equipment?
Can USP chapter <1058> also be used as state of the art in Europe?