Meeting date: March 14, 2023, 11: 00 AM ET
The FDA Draft Guidance on Computer Software Assurance has been released for nearly six months now.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.
Join us for a panel discussion and hear from seasoned experts who have chartered a path through these murky seas:
Speakers:
Hillary Driscol – Sr. Director CSV, Seagen
Barbara Voss – Sr. Project Manager, Seagen
Stephen Cook from Compliance Group will moderate this session.
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
