Why should you Attend:

FDA Commissioner Margaret Hamburg recently announced several new enforcement initiatives. They are certain to impact your regulatory risk profile. How will you prepare for software quality, software validation and 21 CFR part 11 planning?

Extensive use of automated manufacturing, laboratory, QA, QC, complaints, CAPA, Adverse Events systems puts companies at risk. FDA field staff has been trained on software validation and 21 CFR Part 11 inspection and enforcement. Many companies have fallen behind in their software validation practices. Now is the time for forward planning in this crucial area. This executive planning session discusses the key elements on which to focus. The attendee should leave this strategic planning session confident in knowing how FDA will approach software validation enforcement and how to prevent needless inspections, as well as how to satisfy an FDA inspector.

Areas Covered in the seminar:

• Outline of new FDA enforcement approach.
• When will FDA issue a Warning Letter for software validation.
• What happens after a Warning Letter is issued under the new enforcement system?
• How planning can help now and in the future.
• The pivotal role of the Director of Software Quality / Software Validation.
• How your people can really help or hurt you.
• Effective software quality / validation structure.