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Rocky
Mountain Regulatory Affairs Society
presents
RMRAS Annual FDA Update
Wednesday, October 26, 2022
4:30 pm - 7:30 pm
Sheraton Denver West Hotel
360 Union Blvd, Lakewood, CO
80228
RMRAS is honored to again host the RMRAS Annual FDA Update. The FDA Panel
includes:
* Lauren Priest, OMDRHO Compliance Officer
* Vicki Cruz, OMDRHO Supervisory Consumer Safety Officer
* Kathleen Tormey, OHAFO Compliance Officer
* Mark Harris, OHAFO Program Division Director, Denver District Director
(see panel bios
below)
As in the past, RMRAS members are encouraged to submit questions for the panel's insights
and comments. Please send your questions to programs@rmras.org by Wednesday, October 19,
2022.
Schedule:
4:00 – 4:30 Registration
4:30 – 6:00 Presentation by FDA Panel
6:00 – 7:30 Networking with refreshments and a cash bar
Sponsors:
RMRAS would like to thank the following companies and university for their sponsorship of
the 2022 Update:
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AlloSource, one of the largest human tissue providers, honors tissue donors by creating innovative dermal, cartilage, tendon, fascia,
bone, amniotic, and living cellular allografts to help heal patients. Since 1994, the organization has continued to advance its allografts to improve patient outcomes, serving as a trusted
tissue partner to the medical community. Learn more at allosource.org.
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ERI Group is a full-service firm offering expertise in product
design and development, regulatory affairs, quality assurance and contract manufacturing. With 35 years of experience and deep technical expertise to handle the most complex projects, we partner with
clients to bring medical innovations to life.
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Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health
technology company focused on improving people's health and well-being and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment, and home
care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. News about Philips can be found at www.philips.com/newscenter
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Temple University's School of Pharmacy pioneered graduate
education in Regulatory Affairs and Quality Assurance (RAQA) in 1968. Today its RAQA graduate program reaches students around the world with its four master's programs, 80+ courses, and 15
certificates focusing on pharmaceuticals, biopharmaceuticals, medical devices, global pharmacovigilance and clinical trials. Faculty are industry and FDA experts who offer online courses
conveniently scheduled on weeknights and weekends to accommodate working professionals. Students may pursue courses three semesters a year, tailoring their studies around their busy work
schedules to accelerate their career paths in industry or FDA.
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Panel Bios
Lauren Priest, OMDRHO Compliance Officer
Ms. Priest joined the FDA in 2008 as an investigator for ORA in the Dallas District Office
conducting both domestic and international inspections, focusing on medical device and human tissue work. Lauren later completed a detail at FDA's China office (Beijing) conducting inspections
in-country, as well as a detail at CDRH Office of Compliance as a reviewer. In 2015, Lauren moved to the Denver District Office to become a Compliance Officer specializing in medical device
work. She has worked on several high-profile cases working to gain compliance from industry to fulfill the FDA’s mission of protecting public health. As an SME, Lauren also works on
Agency policy and procedure development and training of new FDA investigators.
Vicky Cruz, OMDRHO Supervisory Consumer Safety Officer
Ms. Cruz is currently a Supervisory Consumer Safety Officer (SCSO) based out of the San Diego Resident Post of the Los Angeles District Office. She is assigned to the Medical Devices and Radiological
Health West (MDRHW) Investigation Branch, Group 1, responsible for medical devices investigators throughout Southern California and the Pacific Northwest. Previously, she was a Medical Device
Investigator assigned to MDRHW Group 2, based out of Denver. Vicky came to the FDA with over a decade of quality assurance and regulatory affairs experience in pharmaceutical manufacturing in the
Denver Metro area after being active duty in the Air Force.
Kathy Tormey, OHAFO Compliance Officer
Kathy Tormey is a Compliance Officer in the Office of Human and Animal Foods Operations (OHAFO), Division West 4, located in the Denver District Office, where she focuses on regulatory issues for
human and animal foods. Prior to becoming a Compliance Officer in 2018, Kathy was a Consumer Safety Officer for 10 years in the Denver and Chicago District Offices, conducting inspections in numerous
program areas, with a focus on medical devices and dietary supplements. Prior to joining the FDA, Kathy conducted clinical research at various academic medical centers in Chicago, IL and Boston,
MA.
Mark Harris, OHAFO Program Division Director, Denver District Director
Mr. Harris is FDA’s Office of Regulatory Affairs (ORA) Denver District Director and Program Division Director for the Office of Human and Animal Food Operations (OHAFO) Division West 4. As the
District Director, he provides oversight of administrative, partner collaboration, and emergency response functions and is the point of contact for the states of Colorado, New Mexico, Utah, and
Wyoming. As the Program Division Director, he provides leadership and overall management of regulatory activities of the Human and Animal Food Program in the states of Arizona, Colorado, New Mexico,
Utah, and Wyoming. Mr. Harris has held a variety of positions with FDA since 1997 before taking his current roles in July 2021.
To RSVP, go to programs@rmras.org
For questions or additional information, contact Nan Matthews, programs@rmras.org or 303-843-6414.
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