Meeting held the second Tuesday of every month, sponsored by: The New Mexico Biotechnology & Biomedical Association
NMBBA has changed its name to NMBIO!
Date: Tuesday, January 8, 2008
Time: 11:30am - 1:00pm
Place: Science & Technology Park - Rotunda Room 801 University Blvd SE, East End of Building
Cost: $25.00 NMBBA Members/$35.00 Non-Members (includes lunch)
Contact: RSVP to Annie Hooten at anniehooten@aol.com by Friday Noon, January 4th, 2008.
Speaker: Tim Duggins, Senior Partner (The Horizon Phoenix Group LLC)
“One Regulatory and Quality Management System Equals Worldwide Market Access”
One design process, one regulatory process and one quality system can, if properly organized, lead to virtual worldwide market access. Do not repeat expensive and time consuming product testing, prepare multiple technical files, dossiers or STED files. A single design, regulatory and quality process can fully integrate the requirements of many jurisdictions. See how it can be done at this luncheon meeting of the New Mexico Biotechnology and Biomedical Association.
Timothy K. Duggins, Senior Partner, is a skilled consultant and auditor with extensive experience implementing quality systems for manufacturers and distributors of medical devices, biotechnology and pharmaceuticals. He brings a unique perspective to Quality Systems and Regulatory Affairs drawn from more than 20 years experience developing National and International quality system and product performance Standards. An avidly sought out expert, he served as a consultant to such diverse organizations as federal, state and provincial governments, the United Nations, multinational corporations and a three-person niche market manufacturer. Tim’’s expertise spans the entire medical spectrum from setting standards, drafting regulations and implementation of systems in support of everything from disposable products, in-vitro diagnostic test kits, to implantable cardiovascular devices.\r\n
Tim also played an important role researching product testing and quality systems as part of the Royal Commission of Inquiry on the Blood System, was Moderator for BioTechnica America - “The Role of Nutriceuticals, Traditional Medicine, and Green Pharmaceuticals in the Human Healthcare Paradigm”, an international conference held in Monterey, California. Tim’’s next international presentation will be Healthpack 2008 in San Antonio, Texas where he will speak on Environmental Regulations and the medical device packaging and sterilization processes.
Prepayment is required by either check or credit card to reserve. Send checks to NMBBA, P.O. Box 80233, Albuquerque, NM 87198 or phone Annie with credit card details on (505) 228-8703.
If your credit card is already on file with us, you only need RSVP. No shows will be charged unless cancellations are received by noon, January 7th.