Speakers

David Abraham
QRS-Associates, UK
Chairman of the ECA GMP-Auditor Working Group
David Abraham is Principal Consultant and Director at QRS-Associates LTD with extensive experience in both business and Quality Management. David is also Chairman of the new ECA Working Group for GMP-Auditors.

Jyotsna Agnihotry
Flavine, Germany
Head of Quality Operations
Jyotsna Agnihotry is responsible for the implementation of the Flavine Quality Management System. She is an experienced lead auditor with a proven track record in overseeing and managing comprehensive internal & external audit processes.

Ian Holloway
Form. MHRA, UK
former GMP/GDP/GCP Inspector
Ian Holloway was GMP/GDP/GCP inspector at the MHRA. Before that, he was Head of the Defective Medicines Report Centre at MHRA.

Dr Afshin Hosseiny
ECA
Chairman of the ECA Executive Board (Foundation Board)
Afshin Hosseiny is Chairman of the ECA Executive Board and an independent consultant also conducting audits of manufacturing sites across Europe and USA. Before that, Afshin was Director of Quality Assurance for the Global Supply Network of GSK.

Maryam Davoudi Keleshteri
CinnaGen, Iran
Validation Manager
Maryam Davoudi Keleshteri has more than 10 years experience in the field of biological and chemical products. Before that Maryam Davoudi Keleshteri was as Head of External Audit and Inspection.

Dr Felix Kern
Merck, Germany
Associate Director and Head of Compliance
Felix Kern is Associate Director and Head of Compliance Launch and Technology Center. Felix is a member of the new ECA Working Group for GMP-Auditors.

Ágnes Kis
form. GMP-Inspector at OGYÉI, Hungary
Compliance Consultant
Before starting to work as a consultant, Ágnes Kis worked as GMP-Auditor at Roche and Novartis. Before her industrial career, Ágnes Kis was Senior GMP/GDP Inspector for the Hungarian National Institute of Pharmacy and Nutrition (OGYÉI) and expert member in various working groups at EMA, PIC/S and the European Commission. Ágnes is a member of the new ECA Working Group for GMP-Auditors.

Katja Manthey
Life Molecular Imaging, Germany
Quality Assurance Manager
Katja Manthey is QA Manager at Life Molecular Imaging GmbH, Global Quality Assurance Management of Contract Manufacturers, License Holders, and Suppliers. Previously, she has worked in various quality functions across the pharmaceutical industry in Germany, Australia, and Singapore. Until recently, she has been an active member of the executive committee of the Singapore ISPE.

Thomas Højsholm Schmidt
CSL Behring, Switzerland
Associated Director and Lead Auditor
Thomas Højsholm Schmidt is Associate Director and Corporate Lead Auditor in Global Quality Systems & Compliance at CSL Behring AG located in Switzerland. Before that, he was 12 years at LEO Pharma A/S in Denmark as GMP domain expert and GMP Lead Auditor. Thomas is a member of the new ECA Working Group for GMP-Auditors.

Dr Ingrid Walther
Pharma Consulting Walther
Consultant and Auditor
Dr Ingrid Walther is an independent consultant and has more than 25 years of professional experience, including in the areas of R&D, QA/QC, auditing and management of strategic projects..