The Southern California Discussion Group of the ASQ Biomedical Division and the San Diego Section of ASQ Jointly Present:

How to Pass an FDA Inspection:
               An Industry Roundtable Discussion

About Our Speaker 

Discussion Leader: Patricia Stewart Flaherty, M.Sc., CQA    

Patricia is a Pharmaceutical and Biotech regulatory compliance expert. She is semi-retired after more than 20 years of experience in the pharmaceutical and biotech industries. She currently provides quality consulting and is a Senior Adviser to Washington DC on Regulatory/QA for ASPR/BARDA (The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) inthe Department of Health and Human Services.) As an expert in Regulatory and Quality matters relating to medical countermeasures and counter terrorism,Patricia has authored several publications and presented lectures nationally and internationally.  This Roundtable Discussion will utilize the synergy of our well-versed Subject Matter Expert along with your Regional Industry Peers. Please submit your discussion questions on-line and help make this a valuable experience for everyone.

 

LOCATION: NuVasive    7475 Lusk Blvd. San Diego, CA  92121 View Larger Map Getting inspected by the FDA causes panic and fear in the hearts of many when the FDA inspectors show up at your facility.  This ASQ event will share the experiences and tips on what you can do to prepare your company for an inspection.  This session is beneficial to clinical stage and commercial organizations.   Objectives of the session: ·      Learn how quality auditing and getting inspected are very closely linked ·      How to transition successfully from clinical to commercial ·      Understand Quality Systems ·      Effective quality auditing ·      Inspection preparation ·      Inspection management ·      Post inspection and responses to FDA-483's Register here on-line: http://acteva.com/booking.cfm?bevaID=195680 Members $20 / Non-Members $30  (.3 R.U.s Awarded) To encourage interaction, seating is limited to the first 40 registrations, so sign up soon! Walk-ins welcome based on seating availability however food can not be guaranteed.  Walk-in payment is limited to check only (no cash or credit card) for the amount of $30. No refunds but substitutions are allowed. Food: Dinner is provided. For more information, contact: Karen Liu at (858) 909-1973 e-mail:  kliu@nuvasive.com or Abe Wong at 858-231-9399 email:  awong@gmpsigma.com As volunteers in a not-for-profit professional organization ASQ Biomedical, SCDG (Southern California Discussion Group) is committed to providing low cost high value events for biomedical professionals and the local community.  We are able to keep our costs low by utilizing a registration system that incurs minimal administrative overhead expenses and minimizes excess time and effort spent by our volunteers to bring you these events.  Please help us continue providing low cost quality programs to you by using the system that works well for us.  If you do not wish to use the registration system to preregister, you may attempt to register at the event, however seating is limited therefore entrance and/or food can not be guaranteed.  Also, due to the nature of the low pricing scheme and the registration system used, we are unable to perform refunds.