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...

The secret is - HIPAA Rules are easy and routine to follow - when they are explained step-by-step in plain language. In this seminar Paul Hales will capture your attention with visual presentations, discussion and learning exercises and show how to find the right rule with the step-by-step procedures you need when you need them. Seminar Takeaways Thorough Understanding of HIPAA Rules What they are How they work together Why and How they were m...

Prior to developing a process control plan as part of an overall risk management strategy, process development studies must be completed. The objective of these process development studies is to gain knowledge and understanding about how variation in process parameters explains variation in the product quality characteristics of the product. The use of DOE methodology provides a means to identify process parameters which impact product quality...

Course "New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Transportation and Logistics food transportation food safety rules are currently being finalized by the U.S. Food and Drug Administration (FDA). Under congressional instructions, the Food Safety Modernization Act (FSMA) requires the...

30th Large Installation System Administration Conference (LISA16) LISA: Where systems engineering and operations professionals share real-world knowledge about designing, building, and maintaining the critical systems of our interconnected world. LISA is the annual vendor-neutral meeting place for the wider system administration community. The LISA16 program addresses the overlap and differences between traditional and modern IT operations an...

Overview: 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 FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal r...

The need to evolve is today's only certainty. With reimbursement down, accountability up, and patient expectations on the rise, what changes do you need to make to position your organization for success? The Revenue Cycle Solutions Summit brings together thought leaders, experts and financial decision makers from all across the United States to answer that question and more. Join us in Boston for an intense day of problem solving, innovation a...

When it comes to protecting your organization’s data, no one has all the answers, and going it alone can be a recipe for disaster. Whether it is the threat of cyberattacks from the technologically sophisticated, the misuse of protected health information by a well-intentioned employee or complying with HIPAA, the challenges are persistent and growing. The Boston Privacy & Security Forum brings you together with senior healthcare IT p...

Governing looks forward to returning to Boston in November for the 2016 Massachusetts Leadership Forum. The Commonwealth has achieved important progress in the recent years, investing in local ecosystems to attract economic development and help propel future innovation and job growth as well as making great strides towards becoming a national leader in energy efficiency. Still, significant challenges remain yielding opportunities to partner wi...

Healthcare is undergoing a massive transformation. That’s no secret. Reimbursement is shrinking, providers are being asked to shoulder more risk, and patients are more involved in their care than ever. The ability to use analytics to transform data into actionable information – smarter business and clinical decisions – will play a big role in who survives this transformation. That’s not hype – it’s reality....