Organization of Regulatory and Clinical Associates
P.O. Box 3490
Redmond, WA 98073
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FDA Presentation: Facility Inspections and Product Recalls (FDA Speakers)
NOTE: THIS IS A MONDAY MEETING
TOPICS:FDA Presentation: Facility Inspections and Product Recalls, Corrections & Removals (FDA Speakers)
TOPICS DESCRIPTIONS:
Medical Device Inspections - An introduction to how FDA inspections are conducted with an emphasis on medical device inspections.
Product Recalls - 21 CFR 806 explains the medical device recall process. Along with 806, it also covers part 7, and provides links to other guidance documents. It provides a big picture view of the recall process highlighting key elements before, during, and after a correction/removal.
SPEAKERS: Vanessa Y. Jacobs, FDA Supervisory Investigator and Theresa Kirkham, FDA Recall Coordinator
SPEAKERS BIOGRAPHIES:
Vanessa Y. Jacobs joined the FDA in 2010 and has experience with food, biologics, and bioresearch monitoring inspections. She is currently supervising a team of medical device and mammography quality Investigators.
Theresa Kirkham is a recall coordinator with the Office of Medical Devices and Radiological Health Operations (OMDRH), Division 3 West. Before joining the FDA, Theresa served as a member of the Security Forces in the United States Air Force in Okinawa and Turkey for four years, with short-term assignments in Kuwait, Korea, and Oman. She attended California State University San Marcos and earned a Bachelor of Science in Biology and a Master of Biotechnology. Over the next several years she worked for a firm that produced antibody-based treatments for cancer. Ms. Kirkham then joined the FDA as a Consumer Safety Officer in the Southwest Import District, at the Otay Mesa Resident Post for three years. After Import Operations, she was selected to support the Generic Drug User Fee Act at the San Diego Resident Post. During her three years as a GDUFA CSO working with the Office of Pharmaceutical Quality Operations (OPQO), Division IV, Ms. Kirkham received both drug and medical device training to conduct inspections of drug/device combination products domestically and internationally. She became an OMDRHO recall coordinator in February 2018.
WHO: Clinical, regulatory, quality, manufacturing and legal
This meeting includes:
- Coffee and tea
- Pastries and fresh fruit
Attendance at this meeting may be applied as 1.5 points towards RAC re-certification.
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