Brian Hasselbalch is the Acting Director, Division of Policy, Collaboration, and Data Operations for FDA. He has been with FDA for 21 years. He began his service as an investigator and was performed primarily drug process inspections and related investigations in California and overseas.
March 24 - 27, 2015 --Conference Venue is the Cintas Center on the Xavier University campus
Dale Carter is the Global Director of Quality for the JM Huber Engineer Materials Silica Business Unit. He is responsible for product quality and compliance with IPEC/PQG GMPs for the manufacturing of Silica products at facilities in Tennessee, Maryland, India, Finland, and China. He represents JM Huber as a member of the International Pharmaceutical Excipient Council of the Americas and is a Past Chair.
Bob Zinser is the North American Vice President for Commercial Technology at Patheon. Patheon is a provider of pharmaceutical development and commercial manufacturing services.
Gwyn Murdoch is currently the Director of Quality Assurance for Procurement at Eli Lilly. In this role, she is responsible for the Corporate Supplier Quality Auditing and Supplier Quality Management (SQM) program supporting commercial manufacturing globally for Lilly human health drug products/devices and Elanco animal health products. Ms. Murdoch also has extensive quality experience in the areas of the Materials/Packaging & Labeling Quality Systems, the Distribution of Finished Products, Incoming Purchased Materials, and Biosynthetic API manufacturing. Ms. Murdoch completed her Bachelor of Science degree in Chemistry/Mathematics and her Master of Science degree in Organic Chemistry at Central Michigan University and has worked for Eli Lilly and Company for 28 years.
Stacy Berkshire, Vice President International Quality Operations for Perrigo. She is a Senior Quality professional with expatriate experience in a global business environment. Highly experienced and proficient in Lean Six-Sigma concepts, methodology and tools and building multi-functional global teams to facilitate organizational change.
Operational expereice includes leading quality and operational integration following aquisitions; leading pharmaceutical manufacturing and packaging operations in the U.S., leading quality operations in the U.K. and currently overseeing quality operations, including supplier quality management for all international Perrigo locations including China, India, Mexico, the UK and Israel. Also, experience in Social Compliance and ETI standards.
Lean Six-Sigma experience includes leading the Perrigo’s global Continuous Improvement Office (CIPO) which includes five Corporate Black Belts as direct reports and partnerships with over 1,600 trained belts at various belt levels imbedded within the organization. The CIPO is responsible for driving a continuous improvement culture through empowering and engaging employees at all levels to practice problem solving using Lean and Six Sigma tools. The CIPO team also facilitates enterprise process improvements and value stream mapping in production, quality and business transactional areas to improve efficiency, effectiveness and compliance.
Organizational change initiatives include: participating in acquisition integration activities and leading the quality integration of new businesses; developing and leading Quality culture change program; creating GMP, Right the First Time, Human Error Reduction and other quality training programs; building communication plans to cascade communication throughout the 1,200 quality employees; working with leaders to develop long and near-term strategic plans; executing vehicles to facilitate learning amongst the 13 Perrigo sites through annual forums, quarterly WebExes and facilitating global meetings to improve alignment and team-building.
The PharmaLink conference seeks solutions to important and complicated issues by aligning with the strategic priorities of the Food & Drug Administration. We help participants create links to drive new thinking. The solutions might not be evident within our industry, so we explore beyond industry, beyond borders, and beyond comfort zones. Don’t miss this opportunity to join your colleagues and global regulators from around the world so you can make a meaningful difference for your organization and our industry. PharmaLink actively fosters engagement among all participants and regulators, so true opportunity for change can be identified.Learn More
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Pharmaceutical and medical device professionals, as well as their supplier partners visited the Xavier University campus for two days in May to roll-up their sleeves on the Integrity of Supply Initiative.