Overview: QMS is the catch phrase for accreditation and is the backbone of ISO/IEC Standard 17025:2005. The Quality System Manual (QSM) is the bible in a QMS environment because, much like its predecessor, Good Laboratory Practice (GLP), it contains the policies that the laboratory is expected to follow to achieve quality results. It is in fact only the "what to do" component of a QMS. What is also needed are the "how to do it" or procedures a...

Overview: Software's level of complexity and use is expanding at exponential levels. Likewise the potential risks to health follow suit. Problems with software create a number of different hurdles. Software may be a standalone device, control a device's performance, make calculations, identify treatment options or begin to play a more active role in making clinical decisions regarding patient management and treatment. FDA's risk classification...

Course "The A to Z's of HIPAA Compliance" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This two day seminar takes the participants through HIPAA compliance from start to compliance. The presentations explain the history of HIPAA, why it came to being and its evolution. This covers what HIPAA is, what steps have to be performed to be HIPAA compliant an...

Course "Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle (TPLC)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This workshop style training course is supported by comprehensive knowledge of U.S. FDA laws and regulations and 30 year of extensive experience working within in the U.S. FDA regulated industries. In these 2 da...

Overview: Manufacturing involves an attempt to produce items that as closely as possible meet design specifications (e.g., size, strength, etc.). However, all production processes exhibit variation - that is, no two items are identical. What method can be used to reduce such variation? The classic and still most widely used method is called SPC or "statistical process control". SPC is a statistical tool that objectively identifies when it is w...

Overview: Every project undertaken is not a guaranteed success; there are many things that can and do go wrong. Overly optimistic budgets or underfunded projects can result in shortcuts or unrealistic pressures on those working on the project. Staff or resources lacking the skills to work on the project see the assignment as a fast track to promotion and may not be willing to admit they can not handle the project, projects escalated to be done...

The Northeastern Pennsylvania Alliance (NEPA) Procurement Technical Assistance Center (PTAC) invites you to attend the 2016 Government Contracting Showcase.The Luncheon Keynote Speaker will be PA Department of General Services Secretary Curt Topper and Mr. George Bath, Senior Acquisition Advisor at the U.S. House of Representatives will be the morning Keynote Speaker. The focus of the NEPA PTAC 2016 Government Contracting Showcase is on traini...

Are You Smarter Than an 8th Grader? Find Out at a Briefing on the First-Ever Nation’s Report Card for Technology and Engineering Literacy (TEL) Thursday June 16, 2016 Noon – 1:30 p.m. Rayburn House Office Building, Room B339 The National Assessment Governing Board and the Museum of Science, Boston's National Center for Technological Literacy®, in conjunction with the STEM Education Caucus, invite you to learn more about the fir...

When determining a penalty it’s important to take the Douglas factors into consideration, but your decisions must extend beyond them as well.In 90-minutes, federal employment law attorney Robert Erbe will walk you through all the factors involved in proposing appropriate penalty that will survive third party scrutiny. Mr. Erbe will not only address the penalty at the time of the decision letter, but also at proposal letter time.After thi...

Overview: Biosimilars in the US, including new regulations, existing guidelines, direction from Congress, meetings with the FDA, INDs that have been filed and NDAs that have been filed. We will also discuss the current state of affairs in Canada, who seems to be closely aligning itself with Europe.Why should you Attend: Understanding this fast developing area is critical. How will approvals be handled. Will indications be able to be bridged fr...