Speakers

Sebastian Faller
Roche Pharma AG

With over 10 years of experience in the pharmaceutical industry, he holds a degree in pharmacy and has held various leadership positions in Quality & Compliance. In his current role, Sebastian leads the Drug Product Fleet Quality Team, driving overall quality strategy, compliance, and PQS utilization. Simultaneously, as the Functional Head of Central Certification at Roche, he leads a team of Qualified Person, overseeing all GMP activities related to certification and quality oversight of commercial EU products.

Ralf Gengenbach
Gempex

Ralf Gengenbach is founder and managing director of gempex Co. Ltd., Germany. He was active, among others in DIN UA2 (Board for standards ‘biotechnology’), and DECHEMA. He is chairman of VIP3000 as well as of the ECA Validation Interest Group and has published many articles and a book about Qualification. He is still involved in many qualification projects for newly to build factories and active world-wide as 3rd party auditor.

Dr Rainer Gnibl
District Government of Upper Bavaria, Germany

Dr Rainer Gnibl is pharmacist and GMP Inspector for the District Government and the EMA and performs GMP inspections worldwide. Before that, he was working for the Bavarian Ministry of Environment and Health.

Dr Christian Grote-Westrick
B. Braun Avitum AG

Dr Grote-Westrick is Head of Quality Assurance, Responsible Person and Lead Auditor. After several positions in the pharmaceutical and medical device industry, he has been responsible for GMP/GDP compliance at B. Braun since 2013. He is a member of the Board of Directors of the European GDP Association.

Maik Guttzeit
Freelance Consultant

For almost 20 years Maik Guttzeit was Team Leader Validation at GEA which provides customized GMP Lyophilizer systems. He is member of the GAMP® D-A-CH committee, of ASME BPE Subcommittee on System Design and also of the ECA validation group. In 2018 he joined Bayer AG, initially as Global Technology Manager Aseptic and Sterile and later as principal expert for C&Q concepts. Maik is currently working as a freelance Senior Expert for GMP Lyophilization and Aseptic Projects.

Dr Timo Kretzschmar
TiKrESolution

Since 2003 Dr Kretzschmar has been working in the GxP field. He was Head of Quality at a GLP/GMP-certified laboratory CRO and lecturer for GxP quality processes at various universities in Austria. From 2016 to 2019, T. G. Kretzschmar was an inspector for GLP and computerised systems / data integrity under GxP at the Austrian pharmaceutical authority AGES/BASG. Since 2019, Dr. T. G. Kretzschmar has been working in GxP Consulting as well as a GxP auditor and trainer for various consulting companies, since 2024 increasingly on a self-employed basis. Since 2024 he took over again the responsibility as Head of Quality at a GLP/GMP-certified laboratory CRO in Baden near Vienna.

Dr Jean-Denis Mallet
formerly French Inspection Department

Jean-Denis Mallet was the Head of the Pharmaceutical and Cosmetics Inspection Department at the French Health Products Regulatory Agency (Afssaps). He also used to work in or with the pharmaceutical industry during many years at various positions including Quality Assurance, Production Management, Engineering and GMP Consulting. Now he is member of the ECA advisory board and works for NNE Pharmaplan.

Dr Christian Siegmund
Hoffmann-La Roche

Christian Siegmund PhD. is a pharmacist by education and works for over 26 years for Hoffmann La Roche. Most of the time he was engaged within aseptic filling (incl. heading 2 aseptic fillings for more than 10 years). Beside of this Christian holds lectures on the topic "Quality management in pharmaceutical industry" at the University of Basel and ETH Zürich for seven years. His actual responsibility lies in the development of the Fleet Management Program within Hoffmann La-Roche, setting up company structures, principles, strategies and defining framework for Fleet Management.

Rafael de Souza
Excyte Switerland AG

Since 2004 he has gained extensive experience in good manufacturing practice (GMP), quality assurance and commissioning, qualification and validation (CQ&V) within the pharmaceutical and biotech industries. He has contributed to numerous international projects across Brazil, Denmark, France, and Switzerland. He has been working on projects with a focus on leading quality management and C&Q activities in line with traditional risk-based principles for Commissioning and Qualification, as well as Science and Quality by Design approaches (e.g., ASTM E-2500). Since 2017, Rafael has been an active member of the European Compliance Academy (ECA) Validation Group. In 2020, the ECA group published the first edition of the “Integrated Qualification and Validation” guideline, aimed at advancing CQ&V practices across the pharmaceutical community.