Speakers

Rolf Bauer
Syntegon

Rolf holds a degree in Chemical Engineering. After 8 years of working in the chemical and pharmaceutical industry, he joined Bosch (now Syntegon) in 2000, working in project management and eventually becoming head of the qualification/validation department

Igor Krasula
Valicare (a Syntegon Company)

Igor Krasula is an Electrical Engineer (BMEBiomedical Eng.). Since 2007 worked as Validation Engineer qualifying Bosch/Syntegon Aseptic Filling Social Event On 05 November 2024, you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere. Lines. Currently manages team of validation experts in the field of commissioning & qualification (CQ&V) of Inspection Systems, Medical Device Assembly Machines and Mixing and Granulation Systems for worldwide-located pharmaceutical manufacturers.

Dr Clemens Borkenstein
ZETA

Clemens Borkenstein finished studies with a PhD in Industrial Biotechnology and has been working in biotech industry since 2007. He joined ZETA in 2012 and presently holds the function of Corporate Head of Quality Assurance and Qualification.

Pia Loris
Drees & Sommer SE

Pia Loris has a degree in Chemical Engineering. She has a long-time experience (since 2007) with GMP projects regarding compliance, quality management and qualification activities for facilities, equipment, and rooms with Boehringer Ingelheim and Fresenius Medical Care Deutschland GmbH. She is a senior
consultant working for Drees & Sommer since 2023.

Klaus Eichmüller
Hessian Office for Health and Care

After working in the pharmaceutical Industry Klaus Eichmüller joined the District Government of Upper Bavaria in Munich. Since 1996 he is working in the field of GMP Inspections of manufacturer of medicinal products and importers. He was Deputy Head of the Central Authority for Supervision of Medicinal Products in Bavaria" as long as it existed and has been Head of the Inspectorate for Drug Products, APIs, Blood Products and Tissues in Hesse since March 2014.

Rafael de Souza
Pharmaplan

Rafael is MSc in Analytical Chemistry and is PMP certified. Since 2004, he has gained wide experience in good manufacturing practice (GMP), quality assurance and commissioning, qualification and validation (CQ&V) in the pharmaceutical and biotech industries from projects in Switzerland, Brazil, Denmark and France. He has been working on projects leading activities following traditional principles for Commissioning and Qualification as well as Risk and Science based principles (including projects based on ASTM E-2500).

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.

Dominik Unglaub
gempex

Dominik Unglaub is a trained pharmaceutical technician and “Industriemeister” He is with gempex in Switzerland since two 2 years. Dominik has been involved in the field of qualification dayly within his consulting activities He had the special opportunity to defend his qualification programs and concepts as part of various inspections.

Maik Guttzeit
Bayer

Maik Guttzeit holds a Dipl.-Ing. degree in general process engineering. For almost 20 years Maik 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. Since 2018 he is with Bayer AG, first as Global Technology Manager Aseptic and Sterile and in his current role as principal expert for C&Q concepts.