Trend topics continue: integrated qualification, data integrity, and more

The year 2018 will continue to be strongly influenced by current issues in the fields of qualification and IT validation at gempex. With profound and up-to-date expertise in tow, the GMP experts look forward to challenging tasks with their clients.

At the lounges in Karlsruhe, the GMP experts from gempex provide insights into various projects during the Real Life Presentations, discuss possible problems, and offer suitable solutions, while also being available for personal exchange. For example, on the topic of "Integrated Qualification".

Everyone who has dealt with qualification knows that it is one of the most important tools for quality assurance. It is also well known that it often involves a lot of effort, paperwork, and costs. Specifications, FAT and SAT, functional and detailed specifications, cross-departmental collaboration, and signatures – countless documents and time-consuming agreements contribute to the perception that qualification ultimately acts as a project blocker. The call for reducing effort is growing louder. At the same time, efficiency should be increased. And all this without compromising quality. Is that possible?

Considering qualification from the start of the project, i.e., already in the engineering phase, the solution is actually obvious. It sounds simple but still has pitfalls. Moreover, the topic is not new; only formalistic paperwork and the involvement of many disciplines increasingly blur the boundaries. Therefore, it is essential to establish clear assignments of activities and documents between Good Engineering Practice and Good Manufacturing Practice. Where to set the boundaries, which regulations significantly reduce effort on both sides, and how to implement successfully, the GMP experts from gempex know and can provide many helpful tips.

Below, you will see which other current topics the GMP experts will discuss at the lounges and provide practical tips for a smooth project process:

02/06/2018, 10:00-10:30 AM, Room 3
Validated IT System – and then what?

02/07/2018, 1:30-2:00 PM, Room 3
The FDA is coming! Strategies for successful preparation, pitfalls, ArtScience of a US inspection

02/08/2018, 10:00-10:30 AM, Room 3
Well advised from the start. Challenges and practical experiences of integrated qualification during the construction of a logistics center

02/08/2018, 12:30-1:00 PM, Room 3
Risk Management: Basics and essentials for beginners

By the way:

In December 2017, the first edition of the gempex magazine "From Experts for Experts" was published – on the topic of qualification. A kind of compendium of all technical contributions from gempex. Come by the gempex booth D1.3 at the lounges in 2018 and pick up a copy.