Overview: Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willful neglect or non-compliance. This presentation addresses HIPAA regulations from a different perspective - from a personal perspective - from the perspective of the person in charge of moving an organization or faci...

Most civil, municipal and environmental practitioners involved in construction and transportation projects require a working understanding of soil behaviour under various loading and environmental conditions. This course provides an opportunity to understand basic concepts of geotechnical engineering used in a variety of applications so that participants can gain confidence in dealing with subsoil related problems that they encounter on engine...

Overview: The seminar will begin with an over view of data science and many the steps required for collecting, cleaning, organizing and deriving information out of data. The steps are common to all of the tools and will form the foundation for analyzing, comparing and utilizing the tools used in the remainder of the seminar: R, pandas and Deedle. Topics covered in the foundation are: Organizing information into data frames Mutating data frame...

We will consider the following: The Design Control requirements of the CGMPs, 21 CFR 820.30 The Design History File - documenting Product Design Control and its nine elements The Device Master Record and the Device History Record The EU's Medical Device Directive The "Essential Requirements"; and their documentation The remaining elements of a Technical File / Design Dossier Trends Two attendee projects Why should you attend? This seminar / wo...

Course "Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals: 510(k)/Pre-IDE/IDE and PMA" 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 designed based on 30 year of regulatory affairs experience in preparing more than 150 successful U.S. FDA submissions for major medical device companies. In...

Overview: The objectives of this course will be to demonstrate from real life audits conducted by the Federal government what your highest risks are for being fined (some of the risk factors may surprise you). In addition this course will cover the highest risk factors for being sued by patients for wrongful disclosures of PHI. The course will also cover the manner in which patients are now using state laws to sue for wrongful disclosures. Sta...

Overview: Drug and device research is confusing and difficult on its own but when you start combining drugs with devices the regulatory landscape changes as there are more nuances to deal with. Knowing how drug and device studies are each regulated is important in navigating the challenges posed by studies that wish to use both. It is also important to be aware of current guidance affecting the use of both drugs and devices in a study as well...

Join the ACT-IAC Small Business Alliance on Thursday, January 14th at the Residence Inn Springfield Old Keene Mill for Straight Talk featuring Rory Schultz, Deputy CIO of Food and Nutrition Services with the USDA. Rory Schultz is a 28 year federal employee with 22 years experience in IT customer service, 19 of which have been in leadership positions. He began his Federal career as a summer intern and research analyst with the Executive Office...

Overview: Today's health care delivery occurs in a diverse, fast-changing, multidisciplinary health care environment. This often presents challenges to the health care professional that are not easy to navigate. Medical records and their confidentiality have long been the exclusive province of state law, but has now been recognized for some time in the federal HIPAA statutes and federal regulations. Differing and even conflicting sources of re...

ASSOCIATION MONTHLY MEETING *** The monthly meeting of the Government Contractors Association is the one place where business owners, government professionals, and industry experts can come to network, meet possible teaming partners, connect with agencies, get best practices from successful peers and learn how to navigate the maze that is government contracting. This month's event is: FRESH START TO THE NEW YEAR Goal Setting for Business Owner...