Panel sessions provide an important opportunity for you to engage in valuable discussions with your colleagues. This is your chance to ask questions and explore solutions to many of the challenging issues regarding medical device quality systems.

The moderator of the panel sessions, Ernest Carabillo, will pose initial questions for each panel member to address, based on respective experiences. All participants are invited to voice questions to individual panel members or to the entire panel.

Panel Discussion - Tuesday, March 30^th at 5:30pm
I. Experiences with QSIT/Traditional Inspections

Panelists: Russ Davies, Patrick Reda, Donald Segal

Preliminary questions will include:

1. What effect is the new warning letter policies having on both domestic and foreign FDA inspections?
2. Do the current inspection approaches by the FDA reflect a move by the FDA to pre-Kessler enforcement or is it a result of lack of sufficient and experienced resources?
3. What should a cost conscious company's approach to compliance be in light of the seemingly less stringent enforcement by the FDA?
4. Will the FDA move towards a "notified body" type inspection or will the "notified bodies" move towards an FDA investigative inspectional approach?
5. In this time of apparent policy shift on the part of FDA, how does one best keep up with the seemingly new points of emphasis?

Panel Discussion- Wednesday, March 31 at 3:15pm
II. Management Responsibility for QA/RA

Panelists: Cal Bowman, Bob Dicheck, John Malloy

Preliminary questions will include:

1. How does one determine the appropriate levels for "management with executive responsibility" involvement in QA/RA issues?
2. How do you deal with senior management who doesn't want to participate in solutions for important issues?
3. Do "Boards of Directors "have obligations for compliance with regulatory compliance? If, so how will this affect D&O insurance?
4. What is the best way to use "risk management" techniques to gain senior management support?