FDAs new enforcement initiative â€“ Webinar By ComplianceOnline (Pharmaceuticals Trai)
Venue: Online Event
|Event Date/Time: Jan 12, 2012||End Date/Time: Jan 12, 2012|
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.
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