Now that the HIPAA rules have been in place for more than a dozen years, the days of advice and counseling have been replaced by a hard-nosed enforcement attitude, where HHS OCR is ready to make health care organizations that violate the rules feel some pain for their actions. If your organization is not ready, the HIPAA rules have new, significantly higher fines, including mandatory minimum fines of $10,000 for willful neglect of compliance....

An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is nece...

"Why is FDA at my Facility, and What do I do During an Inspection" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an F...