Join regulatory affairs colleagues from the San Francisco Bay area for an afternoon of networking and an expert presentation entitled, “Getting Cooperation for Regulatory Compliance: An Interactive Workshop.” The event is sponsored by the RAPS San Francisco Chapter and is intended to promote knowledge advancement and facilitate networking among local regulatory professionals. Attendees of this meeting are eligible for two RAC recertification points.
One of the major challenges facing regulatory professionals is eliciting cooperation from within their organizations for compliance with regulatory requirements. Nancy Singer, President of Compliance-Alliance and former special counsel at AdvaMed, will share the results and lessons learned from an industry survey she conducted to assess how management controls can be used to achieve cooperation on regulatory compliance. Later in this interactive workshop, Singer will open up the discussion to build on the survey findings and explore with attendees their approaches to motivating compliance in their organizations.
A full meal will be available for all meeting registrants!
Speakers:
Nancy Singer, President, Compliance-Alliance
Nancy Singer founded Compliance-Alliance LLC to specialize in professional development for those employed in the drug and medical device industries. Previously she was the founder and the Executive Director of the Medical Technology Learning Institute, an educational entity within AdvaMed that provides training on FDA/CMS regulatory requirements. She also served as AdvaMed’s Special Counsel for FDA compliance and enforcement matters. In her role as Special Counsel, Nancy was a member of the FDA/industry working group that evaluated and suggested reforms to the FDA inspectional process.
Before joining AdvaMed, Nancy was the Vice President and Executive Director of the Food and Drug Law Institute. Her career began as an attorney with the United States Department of Justice where she did litigation for the Food and Drug Administration. Subsequently she was a partner at the law firm of Kleinfeld, Kaplan and Becker. Nancy received her B.S. from Cornell University, and J.D. and L.L.M. degrees from New York University Law School. During her career, she taught food and drug law at Catholic University Law School and George Washington University Law School. She chaired the Food and Drug Law Section of the Federal Bar Association, and retired as a Commander in the United States Naval Reserve.
Virginia Perry, ScD, RAC, Partner; Perry-D’Amico & Associates
Virgina Perry is founder and Partner in Perry-D'Amico and Associates, a regulatory and quality management consulting firm, specializing in medical devices. Her more than 20 years of corporate experience in the healthcare field includes Officer and Vice President RA/QA/Clinicals for Nellcor, Inc.; Vice President of QA/RA at Baxter Health Care Corporation; Vice President RA/QA at American Hospital Supply Corporation and Warner Lambert. She has been involved with a variety of products in the drug, large volume parenteral and medical device fields, both domestically and internationally. Perry holds degrees in chemistry and mathematics. She is a Certified Quality Engineer (CQE) and a Certified Regulatory Affairs Professional (RAC). She received the 2001 RAPS Leonard J. Stauffer Award for outstanding contribution to the regulatory profession. She has served at AdvaMed (former HIMA) as a member of the Advisory Committee to the AdvaMed Board on Product Technology and Regulation, at the Business School Advisory Council for Chapman College in Southern California and as ASQ Chairperson. Perry is an active member of RAPS, and she has served on the RAPS Board of Directors, as the society’s Director for the Pacific Region, and presently is a member of the Regulatory Affairs Certification Board (RACB).
Date/Time: Wednesday, 21 May 2008
11:00 – Noon Registration and Networking
Noon – 1:00 pm Luncheon
1:00 – 3:00 pm Speaker Presentations
3:00 – 3:30 pm Question and Answer Period
Location: The Crowne Plaza San Francisco Mid-Peninsula
1221 Chess Drive
Foster City, CA 94404
For directions call +1 650 570 5700, or go to Mapquest.com
Registration fees: RAPS members: $80; Non-members: $90 - Register today.
Local Contact: Anar Kotadia, RAC; +1 408 268 0975, Michelle Ragozzino, Ph.D; +1 408 861-3861
RAPS Contact: Wesley Carr, +1 301 770 2920