US FDA is Coming: Inspection Readiness for the Pharmaceutical Manufacturer

Pharmaceutical manufacturers regularly undergo audits by their customers or the relevant authorities. The target for every company is to ensure that the next inspection runs smoothly by ensuring that processes and documentation are complete and compliant, and that employees are well prepared. In other words, the list of deficiencies remains small because the company is already "inspection-ready" in advance.

Dr. Ralf Aubeck, Principal Consultant at gempex, certified auditor and active in the international cGMP world for 30 years, will illustrate the importance of inspection readiness in his 30-minute presentation on April 20 at the virtual PharmaTechnica, using the example of pharmaceutical manufacturers expecting an inspection by the US FDA. Aspects will be highlighted why the importance of inspection readiness should not be underestimated. Helpful tips for optimal preparation will be given and answers to the following questions will be provided:

  • How does the company's inspection readiness pay off in concrete form?
  • What happens to sites that are not sufficiently prepared?
  • What is special with US FDA investigations?
  • How helpful can external support be and how does it facilitate the successful cGMP journey?
  • Which practical tips, useful guidelines and legal tricks should be known?

This year, PharmaTechnica will take place in virtual form for the second time. gempex will not only be represented with a presentation in the session "Quality & Efficiency in Pharmaceutical Production - Latest Developments in Pharmaceutical Production", but will also be available to answer all GMP-related questions at the virtual PharmaTechnica booth from April 20 to 22.

On the   organizer´s website you can register free of charge to attend the conference and the accompanying trade exhibition.

Dr. Ralf Aubeck will be happy to answer any questions about Inspection Readiness at any time: