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Panel: Don't Just Check the Box! Effective Risk Management Practices in Product Development

Sally Carter  (Director of Engineering, Cognition Corporation)

Pat Baird  (Senior Regulatory Specialist - Head of Global Software Standards, Philips)

David Rothkopf  (President, MEDICept)

Michelle Lott  (Founder & Principal, leanRAQA)

Location: Biomed Room 2

Date: Wednesday, September 16

Time: 11:20am - 12:00pm

Track: Track B: Next-Generation Design Trends & Innovation Strategies

Vault Recording: TBD

The isolated nature of risk tools often results in data inconsistencies and unnecessary duplication, increasing the potential for errors and inefficiencies. This panel will explore best practices for interrelationships of risk within design and process development, and how development practices can become more effective at enabling inherent safety by design. It will look at the integration of different risk tools together to drive better decision-making processes (and better outcomes) resulting in less rework through complete traceability between inputs to risk and outputs/process controls.

Topics include:

  • When should you initiate / incorporate risk assessment into both design and process development and how can they all interact more effectively?
  • Tools that may enable efficient usage of risk to drive decisions
  • Top best practices for effective risk management