Organizational Change Management CSA Success Story – Season 4, Episode-2

Topic: Organizational Change Management CSA Success Story – Season 4, Episode-2

Description:

The FDA Draft Guidance on Computer Software Assurance has been released for nearly six months now. While many organizations adopted CSA principles before the release, many more have since begun that journey.

We’ll discuss how Seagen transformed its validation procedures and business culture and how they:

• Overcame resistance to change, including addressing skepticism
• Addressed any lack of buy-in, including tips for engaging stakeholders and senior management…and keeping them engaged
• Effectively communicated strategies along the way and after implementation
• Balanced resource constraints – managing a transformation project while keeping the lights on
• Planned for success during the project and afterward
• Measure what success means now and in the months and years to come