Details 
#606 Recalls, Corrections and Removals, Complaint Handling & Medical Device Reporting, 21 CFR Section 806 and 810
One of the most disruptive compliance activities for any firm is to conduct a recall, field correction or removal. Often times the people managing the recall may be inexperienced with the level of detail expected by the FDA to complete the activity in a timely and efficient manner. This can lead to added burden for an organization and to strained relations with the FDA itself.
The purpose of this course is discuss the mechanics of conducting a recall with a focus on the practical side of this activity. Topics will include how to decide if a recall is necessary, how to interact with the Recall coordinator at the FDA district office, what the FDA expectation will be, how to follow up to insure the recall is effective and finally, how to close the recall activity.
In addition to discussion on the domestic requirements, the course will cover what must be done if products are also sold internationally.
This course will include lecture, discussion and practical activities including writing a Health Hazard Evaluation, writing a recall letter, developing a recall strategy and developing scripting for discussions with customers affected by the recall.
Course Length: 8 hours
Instructor: Connie Hoy
Connie Hoy joined Xoft, Inc as VP RA / QA in December, 2007. Prior to that she spent over 12 years working in the medical laser industry, most recently as VP RA/ QA at Cutera, Inc and prior to that VP RA / QA at Lumenis, Inc.
Connie began her career 22 years ago at a start-up company that developed sterile implantable devices. In 1995 she joined Tissue Technologies as the Director of Regulatory Affairs, where she led the effort to become one of the first ISO 9001 / EN 46001 certified medical companies in the US. When Tissue Technologies was acquired by Palomar Medical, Connie served as a transition team member and subsequently worked for Palomar to be the team leader for ISO implementation at the Palomar home office and for their subsidiaries located in Auburn, CA and Pleasanton, CA. Connie was also an industry representative on the advisory board that consulted with FDA on the implementation of the 1996 revision of the Quality System Regulations.
Connie then joined Cell Robotic, Inc where she obtained the first 510(K) clearance for a medical laser device to be sold into the home. The device was used for obtaining capillary blood samples for diabetes testing. This lead to a move from Albuquerque NM to Woodland CA where she continued her career in the laser industry.
Outside of the office, Connie is the mother of 4 adult children, loves to cook and is a scuba diving instructor.
Email: choy@xoftinc.com
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