| Starts: | Wednesday March 25, 2009 at 8:00am |
|---|---|
| Ends: | Wednesday March 25, 2009 at 5:00pm |
| Event Type: | Training/Seminar |
| Region: | Greater Los Angeles Area |
| Location: |
611 Anton Blvd Suite 700 Costa Mesa, CA 92626 US |
| Price: | |
| Website: | http://www.eventbrite.com/event/292728559 |
| Industry: | medical device |
| Keywords: | Medical Device, Life Sciences, Plm, Kalypso, Regulatory Affairs, Technology, Surgical Products, Devices, Medical Device Seminar, Oracle, Agile, Product Development, Compliance |
| Intended For: | CIO, VP, Director, Manager; Quality, R&D, Regulatory Affairs, Document Control, Products, Technology, Product Development, Engineering, IT, Strategic Programs |
| Organization: |
Join Kalypso and Oracle on March 25, 2009 at 8AM in Costa Mesa, CA for a two hour complimentary breakfast session to discuss best practice models for maintaining compliance while streamlining NPD. Register now at http://www.eventbrite.com/event/292728559.
For today's medical device companies, implementing new product development (NPD) processes that comply with increasing regulatory requirements is a challenge. Many companies have inadvertently deployed overly bureaucratic systems and, as a result, have found themselves with increasing costs and slowing development. Kalypso recently completed research to explore how leading medical device companies – from startups to multibillion dollar enterprises – are balancing NPD with compliance requirements.
This session will explore innovation and NPD best practices unique to the medical device industry, including:
- Project Governance and Decision Making
- Process Structure
- Project Team Organization
- Portfolio Management
- Software Systems & Tools
Agenda:
8AM-8:45AM: Balancing NPD with Compliance; Noel Sobelman, Kalypso
Noel Sobelman is a Partner with Kalypso, the world's premier innovation consulting firm, with over 18 years of consulting and industry experience. Noel has a broad range of medical device company experience in the areas of innovation management, portfolio planning and rationalization, product development, and new product introduction.
8:45-9:30AM: Easing Compliance Challenges with Automation; Todd Hein; Oracle
Todd Hein, the Sr. Director of Medical Devices at Oracle is responsible for supporting sales, product strategy, and Oracle leadership in the medical device industry. Prior to his role at Oracle, Todd was the Sr. Consulting Director at Agile Software. Throughout Todd’s career, he has been involved in corporate management in the medical device industry with concentration in design control and manufacturing management of FDA regulated products.
9:30-10AM: Q&A