Managing Director of Globalworx GmbH with knowledge and experience gained from over thirty years in the regulated pharmaceutical and diagnostics industry.

Viliam is skilled at leveraging management experience to plan and execute complex tasks in the areas of Supply Chain Compliance and Strategy Deployment specifically in:

• Good Distribution and Storage Practice incl. Temperature Controlled
• Tracking and Tracing (UDI and Serialization)
• Supplier Selection and Qualification Methodology
• Due Diligence and Market Entrance

Senior Sales Manager with deep expert knowledge in the International Sales and Marketing Operations covering entire products portfolio for Supply Chain @ Logistics processes more than 30 years.

Christian approach of building bridges to explore new areas in order to gain new experience is unique and high valued in the marketing community.

His areas of focus are:

• New Market Development of complex logistics processes
• Marketing and Sales of high complex Industrial equipment and processes
• Senior Project Management of multinational projects

Operations Manager with knowledge and experience in the area of market communication, operations, supplier management and staffing.

Igor has collected his broad experience in various positions over his 30 years career development with increasing responsibility and level of involvement. His healthy sense for entrepreneurship and broad experience in the operational areas helps him balance risk and value with focus on compliance.

His specific areas of focus are:

• Communication and negotiation with focus on editing and managing complex business operations
• GSP related Supplier Development and Supplier Selection / Qualification
• GDP related Risk Management and Risk Assessment
• GDP related Temperature Mapping and Temperature Monitoring

Marla joined Xavier University in 2008 as the Director of Xavier Health, where she leads initiatives with FDA officials and Pharmaceutical and Medical Device professionals. Marla began working in the pharmaceutical industry for Merck in 1996 where she took on roles of increasing responsibility, culminating in position of Head of Quality Operations at the Merck North Carolina facility. She holds a B.S. in Chemistry from Xavier University, and a Ph.D. in Organic Chemistry from the University of North Carolina – Chapel Hill.

Prior to joining USDM in 2014, Jay was Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health, where he developed and implemented FDA’s UDI System regulation. At USDM Life Sciences, Jay focuses exclusively on providing business process, technology and compliance solutions for the regulated life science industry. Jay held a variety of positions over his nearly 27 years at FDA, including work with design control regulations to reduce the chance of human errors with medical devices, patient safety and adverse event reporting. Jay also worked in the Office of the Commissioner of FDA, and the Office of Compliance at FDA.

Former FDA Investigator and Supervisory Investigator for 16 years Due Diligence Evaluation for cGMP / Quality Systems cGMP / QSR implementation Preparation for FDA pre-approval inspections Performance of mock-FDA inspections Strategy Development in addressing FDA Compliance Issues Audits of suppliers, drug, device and biological manufacturers, etc. FDA Relationship Management Remediation of FDA Inspections and Warning Letters and preparation of response letters to regulatory agencies