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ORCA 2010 Schedule of Meetings
January 20, 2010
Topic: Design Control – Best Practices for Planning and Documenting Design Processes (2nd of 4 part Device Quality System Topics)
Speakers: C.J. Laufman, CSO, US FDA; M. Hoffman, VP, Medicis Technologies Corp;
P. Babcock, Ex. Dir., Medicis Technologies Corp.
Location: Lake Washington Vocational Technology
January 27, 2010
Topic: Special Meeting: FDA 510(k) Overview and Update
Speaker: Heather S. Rosecrans, Director, 510(k) Staff, FDA, CDRH; Office of Device Evaluation
Location: UW School of Medicine, Seattle
February 24, 2010
Topic: RISK Management for Pharmaceuticals
Speaker: Lauret Ballsun, RN, MSN, LBC Pharmaceutical Professionals, LLC
Location: Talaris, Seattle
March 16, 2010
Topic: Requirements & Best Practices for Mgmt Review (3rd of 4 part Device Quality System Topics)
Speaker: Michael Hoffman, MPH, BSI Certified ISO 9001 Lead Auditor, Vice President, Regulatory Affairs and Quality Systems for Medicis Technologies
Location: Bellevue Community College, Bellevue, WA
April 14, 2010
Topic: Electronic Data Capture & Adaptive Clinical Trial Design – Clinical Development Experiences
Speaker: Betty Spann; Sonia Souza, PhD, Gordon Brandt, MD
Location: Talaris, Seattle
May 18, 2010
Topic: Corrective and Preventive Action – Best Practices for Complaint Management (4th of 4 part Device Quality System Topics)
Speaker: Sue Jacobs, QMS Consulting
Location: Bellevue College, Bellevue, WA
June (TBD - Week of 14 June or 21 June)
Topic: Special Meeting: ½ Day Seminar Update on EU Processes (Scientific Advice, Pediatrics, and Joint
FDA/EMEA Initiatives) Co-Sponsored by ORCA & TOPRA
Speaker: Hilde Boone, Pharm, MSc, European Medicines Agency Liaison Official to the US FDA; Industry
Speakers – TBD (All speakers pending confirmation)
Location: TBD
July (TBD)
Topic: TBD
Speaker: Charles Breen (TBD)
Location: TBD
August 18
Topic: TBD
Speaker: Elizabeth Smith, VP, Regulatory Affairs, Dendreon
Location: Talaris
September TBD
Topic: Annual Meeting
Speaker: TBD
Location: TBD (Eastside)
October TBD
Topic: International Clinical Development Update
Speaker: Kirsten Vadheim
Location: Talaris
November TBD
Topic: TBD
Speaker: TBD
Location: TBD
December TBD
Topic: TBD
Speaker: TBD
Location: TBD
Meeting Notices are posted on this website when date, time, speaker,
topic, and location are finalized.
Attendance at meetings may be used as credit towards RAC recertification.
For additional informationor to be added to the ORCA meeting notice email
distribution list, please contact:
Organization of Regulatory & Clinical Associates
P.O. Box 3490
Redmond, WA 98073-3490
Phone: (206) 464-0825
E-mail: info@orcanw.org
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