Hantel Technologies is pleased to announce the next seminar in the 2011 – 2012 Hantel Tech webinar series:
Overview of Medical Device
Safety in California
Speaker: Lilly Chin, CDPH, FDB
Date: Thursday, May 31, 2012
Time: 11:30 AM – 1:00 PM PST
Location: Hantel Technologies | 703 Sandoval Way | Hayward, CA
The first 30 minutes will be used as a networking session, and the seminar will begin at noon. Note that this event will not be recorded or broadcasted.
You are cordially invited to attend in person at Hantel Tech (lunch provided / limited number of seats). Please register on Event Brite for this free seminar.
California has been a national leader and pioneer in food and drug measures, with the first pure food and drug legislation created in the nation a year after the gold rush. It might not be well known that current FDA medical device regulation is based on the California Department of Public Health – Food and Drug Branch, which has nearly an 80-year-old history. The mission of the Food and Drug Branch is to protect and improve the health of all California residents by assuring that foods, drugs, medical devices, cosmetics, and certain other consumer products are safe and not adulterated, misbranded nor falsely advertised; and that drugs and medical devices are effective.
Manufacturers and start-ups might be less aware that in addition to federal requirements for medical device manufacturing, that there are also state requirements. According to the 2012 California Biomedical Industry Report, California biotech and medical device companies are responsible for 27% of the products in the nation’s biomedical pipeline. This seminar will include a description of the role and function of the Food and Drug Branch in California, and how the Sherman Food, Drug and Cosmetic Law applies to medical device manufacturers, with an emphasis on the shared goal of improved healthcare and outcomes for patients between medical device manufacturers and regulatory bodies.
Lilly Chin is a Program Specialist for the Medical Device Safety Section of the California Department of Public Health, Food and Drug Branch (CDPH, FDB). Her duties are to provide technical and program support. Prior to becoming a Program Specialist, she was a field investigator responsible for the investigations of food, drug and medical device manufacturers to ensure that firms were compliant with laws and regulations, and to ensure that products were manufactured such that they were safe and effective for use. Ms. Chin earned her Bachelor of Science degree from San Francisco State University in Clinical Science. Prior to joining the Food and Drug Branch, she worked in the pharmaceutical industry where she was involved in the development of new drugs.
Since 2007, Hantel Tech has hosted a webinar series forum for the medical device community in the Bay Area generally on the fourth Thursday (noon) of each month. Please feel free to peruse former seminars in the series available via the hanteltech.com website and contact us at firstname.lastname@example.org for more information.
When & Where
Hantel was founded in 1999 with a vision of a company that would bring medical devices to market, with all services provided under one roof. Since then, Hantel has become a leader in contract design and manufacturing, having developed hundreds of products for a wide array of applications. Hantel retains a highly qualified and diverse workforce with expertise in all aspects of medical device development and manufacturing. Located near the heart of Silicon Valley, Hantel is convenient and accessible to a wide array of device and bio-tech firms. Providing fast and flexible service, Hantel was built to meet your needs.