In three real life presentations, the GMP experts from gempex are using concrete case studies to report on their day-to-day work and offering solutions to tricky problems.
In the area of IT validation for example, they are illuminating in which cases the GMP EU Guideline Annex 11 applies for automated process control systems and when Annex 15 is used – and why. This requires a meaningful separation of the sub-systems from the overall system. What is validated, what is qualified?
Concrete examples and the basic approach within an overall validation project clarify this highly complex topic.
Another presentation relates to the medical device supplier industry. A report on the qualification and validation of an automated filling plant for medical device disinfectants is being presented jointly with the company Rühl AG. Challenges experienced in this actual project, concrete problems and solutions implemented according to ISO 13485:2016 and GMP are vividly described. All of this from two perspectives: that of the plant operator and contract manufacturer Rühl, and that of the GMP consulting firm gempex.
And what about the topic of modern qualification?
A presentation is dedicated to the overall topic of qualification and the typical mistakes that appear to make this aspect of quality assurance an ordeal for many companies. Universal difficulties in qualification concepts and the qualification processes are illuminated, broken down and reassembled. In particular, the trend to involve manufacturers and suppliers in qualification from the outset, thereby keeping serious problems in check from day one, is discussed here as well. Entirely in the interest of modern qualification.
gempex presentations at LOUNGES
5 February 2019 | 3:30 pm | Room 3
Six mistakes that make qualification an ordeal
6 February 2019 |1:30 pm | Room 3
ISO 13485:2016 compliant qualification and validation of disinfectant production using the medical device industry supplier Rühl AG as an example
7 February 2019 | 1:00 pm | Room 3
Qualification and IT validation of automated systems
The GMP experts from gempex are looking forward to lively discussions – also at exhibition stand D1.2!