Healthcare Laws/Reform

Learn the effective electronic patient engagement tools and comply with HIPAA rules. Register to this webinar. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/Strict-HIPAA-Rules-for-Patient-Engagement-Social-Media-Websites-Email-and-Text-Message-508143/APRIL-2019-ES-TRAININGREGISTRY

In this webinar Speaker will give clear explanation of the HIPAA Rules that apply to Health Care Provider Web Sites and Social Media, you will learn how to keep your Web Site and Social Media dynamic, effective and follow simple HIPAA Rules, HIPAA Rules for Web Sites and Social Media are clear, unequivocal and easy to follow.

Overview: In this session Mr. Wolfe will provide an overview of the Stark Law, including its recent changes. He will also discuss best practices for auditing physician compensation arrangements on behalf of health systems, hospitals, medical groups and physician practices. The webinar will focus on regulatory requirements, key provisions, valuation considerations and potential pitfalls that should be avoided.

Overview: Disruptive activity by practitioners in the hospital takes many forms. When it happens, it is important that the hospital and/or the medical staff take appropriate steps to see that it does not affect patient care or disrupt operations. Why should you Attend: Hospital executives, medical staff officers, and peer review committee members and support staff should attend to learn how to deal effectively with the disruptive practitioner. You will also learn how to prepare for the day when it becomes necessary to terminate such a practitioner's privileges and medical staff membership. You will also gain an understanding of how to develop provisions in the medical staff bylaws to deal with the disruptive practitioner and how to develop a clear and concise policy regarding disruptive behavior.

Overview: Achieving high performing quality focused patient centered cost-effective outcomes based clinical care requires a multidisciplinary approach to delivering patient care. Why should you Attend: Accurate reporting and reflection of patient outcomes is paramount to success and exceling under value-based healthcare delivery and reimbursement models. The accuracy and completeness of input consisting of documentation that best communicates the patient encounter including need for care, investigation, treatment and outcomes drives patient care quality outcomes. Healthcare facilities and physicians face major opportunity costs and hurdles without solid consistent communication of patient care. A major limitation under the theory of limited constraints related to achieving high performing quality patient outcomes is the quality of the documentation of communication of patient care.

Overview: In this session Mr. Wolfe will provide an overview of the Stark Law, including its 2016 changes. He will also discuss best practices for negotiating and drafting administrative arrangements on behalf of health systems, hospitals, medical groups and physician practices. The webinar will focus on regulatory requirements, key provisions, valuation considerations and potential pitfalls that should be avoided.

https://www.traininng.com/webinar/3-hour-virtual-seminar-on-japan---regulatory-filing-requirements-and-compliance-processes-for-life-sciences-200758live?channel=trainingregistry-april_2019_SEO

Overview This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.

Overview The US Government regulates the export of information, commodities, technology, and software considered important to US national security, economic competition, and foreign policy. Since 9/11/2001, the US Government enforcement has increased due to concerns about terrorism. Exporters need a customized compliance program in order to manage their export decisions and to be compliant with the EARs. Penalties for violation of EARs are severe, including fines that can be as high as $250,000 per civil violation and 1,000,000 for criminal violations, as well as 20 years imprisonment per violation.

Overview Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product. Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring of the system.

Overview Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device or other FDA-regulated industry. During the past 30 years, best practices have been developed to ensure computer systems used in these environments can be cost-effectively managed while meeting all aspects of FDA compliance. To take this a step further, we are now looking at ways to ensure the data that resides on these systems is also managed in a compliant manner and one that will provide the best results for operations at the lowest cost.

Overview This course will give an introduction into the Medical Device Single Audit Program (MDSAP). The introduction will give an overview about the program definition, the requirements for the quality management system, how a smart implementation of these requirements in the quality management system is possible and finally how the audit for five countries (Australia, Brazil, Canada, Japan, US) is working.

Overview An overview of what the new Cannabis Act and related regulations and guidelines are, pertaining to the numerous Cannabis related activities in Canada and how it changed the broader regulatory environment. We will cover what this means to you according to the Cannabis activities sought, conducted or to be conducted. We will address a broad picture of how this new landscape impacts the regulatory process as it pertains to Cannabis for both recreational and medicinal use.

Overview This webinar will highlight the salient points of Good Clinical Practice and will enable the participants to understand how to implement GCP to achieve clinical trial best practices, best patient safety and/or successful FDA and international regulatory authority inspections.

Overview The webinar will include the following critical information you will need: Defining what a bioanalytical method is Necessary steps to validate an immunoassay The challenges and opportunities of validating a molecular assay Needs for mass spectrophotometry assays Issues in transitioning between assay classes Best practices for all bioanalytical methods

Overview This webinar will show you that there is no sense in tackling the 'keeping' of the records, by trying to follow Part 11, because the record requirements must come from the parties who provide, create, or change the records. If you are part of the process of 'Collecting' (e.g.: from study nurse to x-ray specialist), 'Using' (e.g.: from sponsor to report programmer, or statistician), or 'Keeping' (e.g.: from coder, software provider, to server and backup specialist), then this webinar will answer the questions: of how important your part is in this process, and how you can help the company safe resources and be compliant. If an effort is made to collect research-, study-, patient- or other important records, they should be kept safe, in a controlled and organized way. That way is defined by the requirements.

Overview The 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. 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. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information

Overview This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR). What the regulations mean is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation. It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.

Overview This presentation will cover the FDA regulations (21 CFR Subpart J) regarding CAPA, how CAPA should be integrated into other branches of your Quality Management System, how to best approach CAPA (including initiation, evaluation, and follow-up verification), examples of documentation you can use to fulfill the CAPA requirement, as well as tips and tricks to what FDA auditors will look for when they come to visit your site.

Overview Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed.