With a total of three expert lectures, the GMP experts from gempex will present well-founded GMP know-how on current topics: Demand-Oriented Development of Quality Assurance Systems (see news of 22.04.2022), Efficient Qualification – the Five Most Common Mistakes in Qualification, and U.S. FDA Inspection Readiness at Contract Manufacturing Organizations.
On May 17, 2022, Dr. Ralf Aubeck, GMP expert and Principal Consultant at gempex, will give a lecture on "The FDA is coming: Inspection Readiness at Contract Manufacturing Organizations (CMOs)". Helpful tips for optimal preparation and reports on experiences and insights into practice will also be given as well as reasons why an inspection readiness should not be underestimated. A well-timed and efficient preparation for an upcoming inspection always pays off - not only through a professional appearance during the inspection itself, but also through confident defense strategies. Through a gap analysis in the preliminary stages, existing weaknesses can be discovered and existing gaps can be closed sustainably.
The deciding success factor is personnel who are experienced in inspections and specially trained to ensure that the presentation of the QM system does not lead to misunderstandings. Regular training sessions and mock inspections reflecting the emergency situation help all participants to face Day X calmly.
What might be interesting to you on the topic of inspection readiness:
The article "FDA is coming" (German language) by Dr. Ralf Aubeck has just been published in pharmind 04/2022. The author reports on valuable practical experience and provides applicable strategies as well as tips, tools and checklists for a successful inspection. The entire article is a guide to preparing for U.S. inspections and is available for free download at gempex.com/gmp-knowledge.
On May 18, 2022, Dr. Martin Melzer, also a GMP expert and Principal Consultant at gempex, will speak on the topic of Demand-Oriented Quality Assurance Systems. gempex already reported, you can find out more here.
On May 19, 2022, Tim Ohlrich, GMP expert and Manager GMP Compliance Projects at gempex, will conclude the gempex lecture series with his presentation "Efficient Qualification – the Five Most Common Problems". If the most common pitfalls in qualification are known, countermeasures can often be taken in good time. For example, when GMP and GEP do not go hand in hand or when specifications are interpreted differently.
Proper qualification planning brings enormous benefits. If the commissioning & qualification strategy is clearly outlined before the start of a new building or modification project, not only the latest qualification aspects can be taken into account, but also the support from suppliers can be optimally utilized. And probably the most important thing is: paper, money and useful time are reduced enormously!
For questions on the topics of Inspection Readiness and Efficient Qualification, our GMP experts Dr. Ralf Aubeck and Tim Ohlrich are available at any time: info@gempex.com
And furthermore, the GMP experts will be happy to meet you for a spontaneous discussion at the LOUNGES from May 17 to 19, 2022 at booth D1.2.