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)
Monday, June 24, 2019, 8:00 AM until 10:00 AM
Lynnwood Convention Center
3711 196th Street S.W.
Lynnwood, WA 98036
Regular Monthly Meeting
RSVP by Friday, June 21 2019
Registration: 7:30 a.m. – 8:00 a.m. PST
Meeting: 8:00 a.m. – 10:00 a.m. PST
PAID FEES ARE NON REFUNDABLE.
PARKING - Complimentary parking available.
Credit card payments can only be accepted online prior to the meeting. If you plan on paying at the door, please note that the Registration Team can only accept CASH or CHECKS.
NOTE: THIS IS A MONDAY MEETING
TOPICS:FDA Presentation: Facility Inspections and Product Recalls, Corrections & Removals (FDA Speakers)
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
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.