Dan Klein (Senior Technical Service Manager at STERIS)

Dan Klein

Senior Technical Service Manager at STERIS

Dan Klein currently holds the position of Senior Technical Service Manager at STERIS Corporation and has extensive experience in the antimicrobials industry. This experience includes over 20 years as a R&D Manager of Microbiology and Clinical affairs as well as management of a contract testing laboratory. His technical expertise includes supporting multiple areas including pharmaceutical, healthcare and Department of Defense applications. Dan received his Bachelor of Science degree in Microbiology at the University of Illinois at Urbana-Champaign and his Master of Arts in Biology from Washington University in Saint Louis, Missouri. He has authored numerous articles and several book chapters in peer reviewed journals including the recent chapter on “Disinfectant Efficacy Testing” in Block’s Disinfection, Sterilization and Preservation. He is also listed as a co-inventor on multiple United States patents. Dan served as the Chairperson of AOAC International's Committee M on Antimicrobial Efficacy Testing and remains active in multiple industry and standards setting efforts.

Malcolm Hammond (APVMA)

Malcolm Hammond

APVMA
Austin Caudle (invited) (Redica)

Austin Caudle (invited)

Redica
Anthony Georgiadis (Sales Director of Amscorp Scientific)

Anthony Georgiadis

Sales Director of Amscorp Scientific
Andrew Hopkins (Director of Compliance at AbbVie)

Andrew Hopkins

Director of Compliance at AbbVie

Andrew has a BSC (Hons) in Microbiology with Genetics and a Post Graduate Diploma in Industrial Pharmaceutical Science. His career history covers a number of areas over approximately 35 years.

Currently Andrew is a Director of Compliance at Abbvie the role includes Auditing of manufacturing sites, Training and mentoring, and interaction with regulatory agencies.

Prior to this, Andrew was an Inspector with the MHRA for nearly 14 years.

Andrea Kurz (Vice Director, External Collaboration Europe of F. Hoffmann-La Roche Ltd)

Andrea Kurz

Vice Director, External Collaboration Europe of F. Hoffmann-La Roche Ltd

Andrea Kurz is Vice Director External Collaboration Europe at F. Hoffmann-La Roche Ltd in Basel, Switzerland. Andrea has 20+ years’ experience in the Pharmaceutical Industry and held various positions in Quality & Compliance and Regulatory Affairs. She is a pharmacist by education and graduated from the Ruprecht - Karls - Universität Heidelberg in Germany.
With focus on Europe and the Middle East she leads External Collaboration Policy and Strategy activities in Quality and Compliance. She actively leads or participates in committees in trade and individual member associations related to strategic quality initiatives, regulations, and conferences. She acts as an advisor for management and staff in the areas of Quality and Compliance and provides policy information regarding external regulations and trends.
As a qualified GMP Lead Auditor she gained excellent knowledge of cGMP regulations and Pharma Quality Systems. As an experienced People Manager and Matrix Leader she has built and led global and cross-functional teams and has established knowledge networks and stakeholder collaborations.

Peter Qiu (External Advocacy Lead, APAC at Roche Genentech)

Peter Qiu

External Advocacy Lead, APAC at Roche Genentech

Dr. Peter Qiu is the External Advocacy Lead for Asia Pacific at Roche Genentech with over 13 years of experience working with the US FDA. He was the Division Director in the Division of Biotechnology Manufacturing, Office of Pharmaceutical Manufacturing Assessment, CDER. He led the assessment of manufacturing processes, facilities, and microbiological control for CDER’s Biologics License Application review and inspection program.

Dr. Qiu has extensive knowledge in microbial controls and sterility assurance assessment as well as in pre-license and pre-approval inspections for biotech products.

Dr. Qiu graduated from the University of Southern California with a Ph.D. in Biological Sciences.

Kim Sobien (Senior Microbiology Consultant at ValSource)

Kim Sobien

Senior Microbiology Consultant at ValSource

Kim Sobien is a Microbiology Senior Consultant with ValSource, Inc. Her pharmaceutical industry career encompasses a breadth of Quality, Compliance, and technical experience with injectable pharmaceutical products, including parenteral pharmaceutical contract manufacturing, pre-filled syringe generics, radiopharmaceuticals, and biologics. Previously she has served as MSAT Contamination Control Lead and a GSK Fellow at GSK, Principal Sterility Assurance Engineer for PETNET Solutions, Associate Director of Regulatory Compliance at Merck, Regulatory Compliance Lead at BD Rx, Inc., and Microbiology Laboratory Manager at Oso BioPharmaceuticals (now Curia).

Kim has a BS in Microbiology from the University of Wisconsin–La Crosse and a Master of Business (MBA) degree with an emphasis in Global Management from the University of Phoenix. She is an active member of the Parenteral Drug Association (PDA), the PDA Southeast Chapter, and a past co-chair of the PDA Annual Global Conference on Pharmaceutical Microbiology.

Stelios Tsinontides (invited) (Director of CDER's Office of Pharmaceutical Manufacturing Assessment US FDA)

Stelios Tsinontides (invited)

Director of CDER's Office of Pharmaceutical Manufacturing Assessment US FDA