Health and Medicine

Overview: This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record. Why should you Attend: Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), Congress defined the term "dietary supplement", and requires that every supplement be labeled a dietary supplement. Areas Covered in the Session: Required steps for CGMP compliance Problem areas, common pitfalls Implementation:Systems,templates and tools Who Will Benefit: Senior Management in Dietary Supplements Industry QA/RA R&D Engineering Marketing Consultants Speaker Profile: John E. Lincoln is a medical device…

Training Options Duration: 60 Minutes Tuesday, March 13, 2018 | 10:00 AM PDT | 01:00 PM EDT Overview: This webinar for HIPAA Covered Entities and Business Associates explains how to use the HIPAA Rules to Prevent, Prepare, Respond and Recover from Cyber Attacks. Why should you Attend: Cyber Threats to the Security of Health Information are at Crisis levels. The latest threats are caused by two security flaws called "Meltdown" and "Spectre" in nearly all "chips" - microprocessors installed in electronic devices like computers, smartphones and tablets. Windows, Linux, iOS, MacOS, tvOS, Android and nearly all operating systems are affected…

Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment. How well do you understand the requirements for supplier management? Could you pass a regulatory audit or inspection without any issues? This course delivers the tools, templates, and methods to help participants…

OVERVIEW FDA and U.S. Customs and Border Protection are using new import requirements.The FDA’s import software screening program (PREDICT) and the U.S. Custom’s ACE software program require more information from the foreign source(s). FDA’s product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. Take away is that the software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry. In addition, information on the entry’s commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. All products regulated by the Food and Drug Administration…

MAIN TOPICS: Resuscitation Oxygen And Ventilation Infections High-Tech Monitoring Nursing Ventilation ORGANIZING COMMITTEE: Paolo Biban Urls: Tickets: https://go.evvnt.com/184765-1?pid=154 Twitter: https://go.evvnt.com/184765-2?pid=154 Facebook: https://go.evvnt.com/184765-3?pid=154 Price Physician: EUR 350 Nurse: EUR 250 Abstract Submitter: EUR 250 Time: 8:45 am - 5:00 pm

Training Options Duration: 60 Minutes Friday, March 9, 2018 | 11:00 AM PST | 02:00 PM EST Overview: In this webinar Mr. Wolfe will discuss emerging governance structures, reporting and documentation requirements, approval processes, and other developing best practices in the industry to help attendees appropriately engage their board and/ or compensation committees in oversight. Why should you Attend: In this webinar Mr. Wolfe will explore the expanding role of boards and committees in physician compensation oversight, in decision-making and in day-to-day policy and process implementation. Areas Covered in the Session: Guidance on Board Fiduciary duties and Responsibility for oversight…

This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors. The program will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy, a "Cleaning Validation Master Plan"…

This two day seminar takes the participants through HIPAA compliance from start to compliance. The first presentation explains 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 and what HIPAA compliance is. It also provides definitions to key HIPAA terms, how to define a Business Associate and how to contract with Business Associates. The second part of the first presentation is an overview of how to manage the HIPAA compliance project. At the end of these presentations there will be a workshop…

Course Objectives: * To highlight the initiatives for monitoring migrants' health, prevent and control infectious diseases in migrants in GCC and EMRO. * To discuss the impact of migrants on the health systems of the hosting countries especially for vaccine preventable diseases, importation of communicable diseases and AMR. * To present the ways to enhance GCC/EMRO preparedness for infectious diseases in migrants during peace and conflict. * To highlight the importance of intergovernmental and international organizations collaboration required to address migrants' health needs in GCC/EMRO. * To discuss the role and impact of migrants on the elimination programs for TB,…

Overview: This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome. Why should you Attend: In December 2010 the FDA changed the way it does audits to include 21 CFR 11 add-on inspections. Very little is known about this, yet the FDA has already issued citations on the subject. Areas Covered In the Session: What is FDA's…

Exhibit Opportunities are available at this conference. Contact us for details. Join us for the 8th annual Sports Medicine Winter Summit, March 7-11, 2018. This year’s conference will be held at the Grand Summit Hotel at the Canyons Resort, Park City, Utah The Sports Medicine Winter Summit is a unique five day educational conference for physicians and medical professionals who care for active patients, athletes – at the professional, semi-professional and amateur level – and/or who engage in athletic activity themselves. The curriculum is directed to Family Medicine, Internal Medicine, Pediatrics, Emergency Medicine, PMandR, Orthopedics specialists as well as Physical…

Training Options Duration: 60 Minutes Wednesday, March 7, 2018 | 10:00 AM PST | 01:00 PM EST Overview: This webinar for HIPAA Covered Entities and Business Associates will identify the top OCR HIPAA enforcement priorities for 2018 and explain simply how you can master HIPAA compliance requirements for each enforcement priority. Why should you Attend: HIPAA Compliance is in crisis throughout the United States. The Office for Civil Rights (OCR), the HIPAA enforcement arm of the U. S. Department of Health and Human Services has just announced results of its recent HIPAA Compliance Audits of Covered Entities (CEs). The audited…

Training Options Duration: 60 Minutes Wednesday, March 7, 2018 | 10:00 AM PST | 01:00 PM EST Overview: This webinar for HIPAA Covered Entities and Business Associates will identify the top OCR HIPAA enforcement priorities for 2018 and explain simply how you can master HIPAA compliance requirements for each enforcement priority. Why should you Attend: HIPAA Compliance is in crisis throughout the United States. The Office for Civil Rights (OCR), the HIPAA enforcement arm of the U. S. Department of Health and Human Services has just announced results of its recent HIPAA Compliance Audits of Covered Entities (CEs). The audited…

Training Options Duration: 90 Minutes Tuesday, March 6, 2018 | 10:00 AM PST | 01:00 PM EST Overview: Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a compliance review you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the understanding…

CCO is partnering with the American Association of Diabetes Educators and the Healthy Trucking Association of America to host 3 live continuing medical education meetings focusing on long haul truck drivers, a population at high risk for diabetes and adverse diabetes-related health outcomes. This interactive seminar is CME-certified for 3.25 credits, and the target audience includes physicians (particularly DOT-certified physicians), physician assistants, and nurse practitioners. Featuring case-based discussions with expert panelists, the agenda will focus on setting optimal glycemic targets, safely intensifying diabetes treatment, managing comorbid cardiovascular risk factors, and risk assessment. For more information and to register, go to…

CCO is partnering with the American Association of Diabetes Educators and the Healthy Trucking Association of America to host 3 live continuing medical education meetings focusing on long haul truck drivers, a population at high risk for diabetes and adverse diabetes-related health outcomes. This interactive seminar is CME-certified for 3.25 credits, and the target audience includes physicians (particularly DOT-certified physicians), physician assistants, and nurse practitioners. Featuring case-based discussions with expert panelists, the agenda will focus on setting optimal glycemic targets, safely intensifying diabetes treatment, managing comorbid cardiovascular risk factors, and risk assessment. For more information and to register, go to…

Course "Validation and 21 CFR Part 11 Compliance of Computer Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and /…

In January 2006, FDA issued a final rule which specified that most pharmaceutical products (including biologics) produced for use in Phase I clinical trial studies were exempted from complying with GMP requirements, as defined in 21 CFR Part 211 under 21 CFR 210.2(c). Section 501(a)(2)(B) of the FD&C Act requires drugs, including IND products, to comply with cGMPs or if they are not manufactured in compliance with cGMPs, they are deemed adulterated. Based on this statutory requirement for manufacturers to follow GMPs, FDA issued cGMP regulations for drug and biological products in the Code of Federal Regulations (in 21 CFR…

OVERVIEW Because the Anti-Kickback Statute is so broad it what it proscribes, healthcare organizations, conducting what would be normal marketing activities in other industries, have run afoul of the Statute on numerous occasions. The Statute and the regulations only tell part of the story. This program will review not only the Statute and its safe harbors, but will provide an in-depth overview of OIG guidance and advisory opinions dealing with marketing activities, as well as a review of case law regarding marketing behavior. WHY SHOULD YOU ATTEND If your organization, be it a hospital, physician practice, DME provider, or any…

OVERVIEW Learn that treating your Medicare patients with Durable Medical Equipment can be great for patient clinical outcomes, a great revenue stream and can be legally compliant. It will also lower healthcare costs. However one must know how to get the proper licensure and know the Federal & State Guidelines. WHY SHOULD YOU ATTEND All practices are facing the fact their professional services reimbursements are shrinking from all insurance companies & especially Medicare. Patient loads are smaller due to the economy and operating costs are skyrocketing. Everyone needs to look at additional revenue opportunities with their own patient base while…