Guenther Gapp, PhD Gapp Quality GmbH

Since 2013, the microbiologist Guenther Gapp has been working as an independent consultant for different clients around the globe and has been engaged in more than 30 projects e.g., in assignments for remediation of companies cited with a Warning letter.

In the previous steps of his career, he served in the pharmaceutical industry for 20 years as Head of QA/QC Microbiology department and Sterility Assurance Expert. During this period, he gained in-depth experience in Aseptic processing key elements, Training and motivation of operators, media fill practices of finished dosage forms and bulk products, environmental monitoring, rapid testing methods, and regulatory agency audits. Guenther has been a subject matter expert in more than 20 FDA audits.

He also created a new sterile risk assessment tool to identify and reduce the microbial contamination and compliance risk of aseptically prepared, sterile products, and this method is used now worldwide. The publication of this Risk Assessment tool won him the 2011 PDA Journal of Pharmaceutical Science and Technology Award. He has been a speaker at several PDA conferences in the past years. Since 2017 he has been a member of PDA´s EU Annex 1 Revision Task Force, Science Advisory Board, and Co-Chair in the Isolator Taskforce. Just recently he won the PDA James Agalloco Award for this Training Course and was also Coauthor in the TR 13 revision 2022.