Toxikon Corporation is pleased to announce that we will host our third annual medical device testing seminar April 23 at our headquarters in Bedford, Massachusetts.
Why you should attend:
Now more than ever, medical device manufacturers know how important effective planning is for getting their product onto the market faster, as lost time equals lost revenue. The most common pitfalls for submissions to governing bodies often stem from lack of knowledge or just plain confusion, as safety-testing recommendations continue to be updated and revised. With new innovations and applications in development, testing guidelines can be vague.
Geared toward professionals in Research and Development, Quality Assurance, Regulatory Affairs and Design Engineering; this seminar will provide a "how-to" guide for submission testing strategies; risk assessment; avoiding regulatory pitfalls and contracting work to CRO's.
Please note: This year's event is closed to those who attended last year's seminar, and is limited to no more than two attendees per company. Deadline to register is March 31, 2009.
Click here for Registration Form
Registration is $525 per person and breakfast and lunch is included.
Agenda
8:30 a.m. - 9:00 a.m. Registration and Breakfast
9:00 a.m.-10:45 a.m. "Biocompatibility for Medical Devices: Considerations for Medical Device Manufacturers regarding ISO 10993 and MHLW guidelines," Laurence Lister, Director of Biocompatibility Services, Toxikon Corporation
10:45 a.m. - 11 a.m. Break and Refreshments
11 a.m. - 12:30 p.m. - "Trekking the Regulatory Landscape: Submission Testing Strategies and Risk Assessment" Judy Andrews, Director of Quality Assurance, and Mary McNamara-Cullinane, Senior Regulatory Consultant, Medical Device Consultants, Inc.
12:30 p.m. - 1:30 p.m. Lunch and Networking
1:30 p.m. - 2:15 p.m. "Sponsor Responsibilities under GLP Guidelines for Contracting Work: An Overview," Amy Schade, Director, Regulatory Affairs and Quality Assurance, Toxikon Corporation
2:15 p.m. - 3:30 p.m. Workshops, Lab Tours
3:30 p.m. - 4 p.m. Refreshments and Networking
For additional information, please contact:
Joann Hoxha, Seminar Coordinator
Office: (800) 458-4141 Ext. 132
Fax: (781) 271-1136
Email: seminar@toxikon.com