For gempex, 2018 will continue to be defined to a large extent by current issues in the areas of qualification and IT validation. With profound and current know-how in their pocket, the GMP experts are looking forward to challenging tasks on behalf of their customers.
At LOUNGES in Karlsruhe, the GMP experts from gempex are not only offering insights into various projects during the real life presentations, reporting about possible problems, and simultaneously delivering corresponding proposed solutions, but are also available for personal exchanges. For example on the topic of “integrated qualification”.
Everyone who has come into contact with qualification knows that it is one of the most important quality assurance tools. It is also known to be associated with a lot of effort, paper, and costs. Requirements and contract specifications, FAT and SAT, functional and detailed specifications, collaboration across department boundaries and signature requirements – countless documents and time-consuming coordination contribute to the ultimate view of qualification as a project blocker. Calls for reducing the cost keep getting louder. Efficiency needs to be improved at the same time. All this with no loss of quality please. It that possible?
In a sense the solution appears obvious: taking qualification into account from the outset, starting with a project’s engineering phase. That sounds simple, yet harbours perils of its own. Not to mention that the issue is certainly not new, but mountains of paperwork due to formalistic reasons and the involvement of numerous technical disciplines are increasingly blurring the boundaries. A clear assignment of activities and documents between good engineering practices and good manufacturing practices therefore needs to be established. The GMP experts at gempex know where to set the limits here, what commitments considerably reduce the effort on both sides, and how to realise a successful implementation. They are able to offer a lot of useful tips.
See below for other current topics that will be discussed by the GMP experts at LOUNGES along with the presentation of practical tips for a smooth project implementation:
6 February 2018, 10:00 am - 10:30 am, room 3
Validated IT system – and what then?
7 February 2018, 1:45 pm - 2:15 pm, room 3
The FDA is coming! Strategies for successful preparation, pitfalls, and the art and science of a US inspection
8 February 2018, 10:00 am - 10:30 am, room 3
Good advice from the outset. Challenges and practical experience with integrated qualification during the new construction of a logistics centre
8 February 2018, 12:30 pm - 1:00 pm, room 3
Risk management: fundamentals and useful information for beginners
Please register at www.expo-lounges.de for your free ticket, code EFYCRWJQ.
By the way:
The first edition of the gempex booklet “By Experts for Experts” appeared in December 2017 – on the topic of qualification. It is quasi a compendium of all gempex technical papers. Visit the gempex exhibition stand D1.3 at LOUNGES 2018 and pick up a copy.
You are not coming to LOUNGES but are interested in this booklet? No problem! Send an e-mail to public-relation@gempex.com with the subject “By Experts for Experts – Qualification” and get your copy conveniently by mail.
Your GMP experts are looking forward to hearing from you!