Dr. Wolfgang started at FDA in 2005 after spending 15 years in the pharmaceutical industry as a technical specialist, focusing on manufacturing and quality of pharmaceutical ingredients. Dr. Wolfgang is now in the Office of Compliance within the Center for Drug Evaluation and Research in ODSIR the office that focuses on the pharmaceutical supply chain. Dr. Wolfgang represent FDA in various standard setting activities (e.g., USP Excipient Expert Committee, ANSI/NSF 363 Excipient GMP) and spend a good share of his time on matters concerning pharmaceutical ingredients (API and excipients).
March 24 - 27, 2015 --Conference Venue is the Cintas Center on the Xavier University campus
Mr. Teitell became the District Director of the Cincinnati District Office in January 2012; and he has been employed with Food and Drug Administrations field operations for thirty-four years.
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.
Michael Taylor is co-founder and CEO of SchellingPoint —enabling multi-party groups to design and execute sustained growth and change initiatives through Alignment Optimization. Specializing in the process of alignment management, Mike has guest lectured on Alignment Dynamics at Wharton and Cornell.
Prior to forming SchellingPoint, Mike was CEO of an Indian IT firm after building SCT Manufacturing & Distribution Systems with five colleagues from Andersen Consulting, where Mike was a Director in the Products Industry, specializing in enterprise software applications.
- See more at: http://www.pragmaticmarketing.com/resources/alignmenta-little-understood-aspect-of-product-management-#sthash.SgYcq9UC.dpuf
Captain Veneziano has been with the FDA for over 20 years and has a B.S. degree in Engineering from the University of Maine. He has been the Director of the Division of Import Operatio ns since March of 2005.
He is responsible for providing leadership, guidance, and direction to approximately 1000 field investigators covering over 320 ports of entries across the country. He provides guidance to all offices within the agency, has briefed Congressional staffers and testified to Congress.
He is the co-lead in the implementation of many of the Food Safety Modernization Act import provisions and provides guidance on the implementation of the Food and Drug Administration Safety and Innovation Act and all others that impact imported products. He began his career in 1992 as a field investigator in the New England District, specializing in Medical Device inspections, where he conducted inspections both in the
domestic and international arena. In 1998, he became a Supervisory Investigator in New England overseeing the Medical Device and import programs. In August of 2003, CAPT Veneziano established, staffed and directed the Prior Notice Center, FDA’s first 24/7/365 operational office.
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
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.
It will be held at the Newport Aquarium. The reception will be in the Riverside Room, which offers spectacular views of the Ohio River and the Cincinnati skyline. You will have an opportunity to explore the one million gallon aquarium that is home to over 90 species including shark rays, jellyfish, alligators, and penguins.