Healthcare

Every year the OIG updates what its focus is for the upcoming year. During this session we will look at the focus for OIG audits and oversight for 2017. These work plans often drive the audits that then occur within our work sites. They provided information that is beneficial for organizations in their striving to be compliant with new regulations.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/OIG-WORK-PLAN-2017-502738/JUNE-2017-ES-TRAININGREGISTRY

Overview We will discuss the importance of applying industry best practices when validating laboratory systems that are regulated by FDA. Any “GxP” system (i.e., the system "touches" product during the laboratory testing or process) must be validated in accordance with FDA guidelines for computerized systems and documented accordingly. This FDA Compliance course will describe the best practices for conducting validation work, including "who" should be responsible for such tasks and "how" the documentation should be accomplished. FDA guidelines are very specific in terms of how this is to be done. In addition, we will touch on elements of electronic records and electronic signatures (ER/ES, or FDA 21 CFR Part 11). Specific criteria must be met in order to consider such a signature as valid in the eyes of FDA regulators. For more detail please click on this below link: http://bit.ly/2r9k1XA Email: referrals@complianceglobal.us Toll Free: +1-844-746-4244 Tel: +1-516-900-5515

Internal auditing is an independent, objective assurance and consulting activity designed to add value and improve an organization's operations. Conducting internal audits in the pharmaceutical and medical device industries is a key element of a quality management system. It is also a regulatory requirement and therefore a company must have a documented and systematic approach to conducting internal audits.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/PROACTIVE-INTERNAL-AUDITING-506392/JUNE-2017-ES-TRAININGREGISTRY

Did you know that Electronic Health Record (EHR) can be used in prospective clinical investigations of human drugs, biologics, medical devices and combination products regulated by the US Food and Drug Administration (FDA)? This includes foreign studies used in support of an application for marketing approval of the medical product. This webinar will discuss FDA's current recommendations on using Electronic Health Records in prospective clinical investigations of human drugs, biologics, medical devices and combination products. A refresher on key requirements for Computer Systems used in Clinical Investigations is also included.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/EHR-FDA-CLINICAL-INVESTIGATIONS-505427/JUNE-2017-ES-TRAININGREGISTRY

This interactive webinar will address the circumstances that regulate medical device sales in the EU. Use of the CE Mark for medical devices is required for selling medical devices in the EU. The webinar will address the use of CE Marking and cover the process of marking which provides an indication of whether the product is in compliance with EU regulations to further allow product commercialization throughout the EU.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/CE-MARK-SELL-MEDICAL-DEVICES-EU-508084/JUNE-2017-ES-TRAININGREGISTRY

This 90-minute webinar gives you an excellent overview of the Omnibus rule changes. Learn what actions to take now to achieve HIPAA compliance with the new Omnibus Rule, to pass an audit or an investigation, and to avoid civil money penalties and criminal convictions.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/HIPAA-HITECH-ACT-505706/JUNE-2017-ES-TRAININGREGISTRY

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 leases 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. Why should you Attend: As health care organizations and physicians develop lease arrangements, they must manage their compliance and enterprise risk by ensuring the their leases are defensible under the Stark Law. Prior to moving forward with any leasing arrangement, the parties should carefully evaluate whether the proposed structure and financial terms support compliance with Stark's technical requirements and key tenets of defensibility so they will be prepared to mount a defense in the event the lease is ever challenged.

Overview: Bundled Payments are becoming more and more recognized as the preferred method of value-based reimbursement by CMS and several other commercial payers. In this presentation this type of payment method will be explained in detail and real-life examples will be given of how bundled payments actually work. In addition, providers will learn ways to optimize their performance under a bundled payment paradigm and how to negotiate bundled service agreements to their best advantage. Why should you Attend: It is critical for providers to understand the emerging CMS payment models and how these new reimbursement structures affect their organizations. Providers should attend this session to learn how to optimize their performance under a bundled payment paradigm and how to negotiate bundled service agreements to their best advantage.

Overview: The webinar will cover how to find out if business associates have the necessary technical, physical and administrative safeguards in place to protect shared protected health information. The webinar will address when a vendor becomes a business associate and how that relationship may change the dynamics. Understanding the Business Associate Agreement (BAA) process and making sure all ten government mandated requirements are in place will be covered. Find out about the use of Vendor Security Questionnaires and how to implement. The webinar will cover breaches caused by business associates and how to handle such an occurrence. If your healthcare organization needs to understand what your responsibilities are in managing business associates, please join us for this informative and interactive course

The webinar topic will be a presentation and analysis of the key advantages and disadvantages of current electronic medical records systems for providers, hospitals, patients, and other stakeholders, the unanticipated problems and issues, a discussion of emerging evidence-based approaches to improving the implementation, effectiveness, and ease of use of EMRs, and a discussion of what the future holds for the further evolution of EMRs. he anticipated benefits of those who designed EMRs included: improved billing and coding accuracy, improved quality of care and outcomes, saved time for busy physicians, decrease costs of care, and active engagement of patients in their care.

The HIPAA Security Rule requires organizations to evaluate risks and vulnerabilities in their environments and to implement reasonable and appropriate security measures to protect against reasonably anticipated threats or hazards to the security or integrity of e-PHI. This is a key step in preventing breaches from occurring. Another important aspect that will be covered is how to train a workforce and making sure 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 the fundamentals of a HIPAA compliance.

Compliance issues related to physician compensation have been a key area of discussion in health care for a number of years. However, because of the substantial awards and settlements in recent Stark Law enforcement actions, compensation-focused compliance has become more than just a compliance issue it is an enterprise risk management issue. This webinar will discuss strategies for ensuring physician compensation plans and compensation-focused governance processes support compliance Given the substantial awards and settlements in recent enforcement actions, compensation-focused compliance in provider contracting has become more than just a compliance concern: it is now considered an enterprise risk management issue.

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 the fundamentals of a HIPAA compliance program. If your healthcare practice, business, or organization needs to understand the requirements of HIPAA compliance or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive course.

This webinar will discuss the Consideration of IQ, OQ, and PQ and their equivalents for processes, equipment (production and test), product, and cGMP e-records / e-signatures.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/IQ-OQ-PQ-VERIFICATION-VALIDATION-PROCESS-503654/JUNE-2017-ES-TRAININGREGISTRY

Overview: Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on complex scientific and technical arguments.

Overview: Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.

Overview: This course is designed to provide participants with an understanding of the regulatory expectations for controlling impurities and degradants (including DNA reactive/potential genotoxic impurities) in drug substances and drug products. There will be ample opportunity to discuss questions and challenges from the participants. Why should you Attend: Upon completion of this course the learner should be able to: Understand regulatory expectations regarding impurities, degradants and potential genotoxic impurities in pharmaceuticals Understand what specifications will conform to regulatory expectations Develop an process for reporting impurities and addressing OOS situations

Overview The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. One of the techniques described in ISO 14971 is Hazard Analysis. This is the most powerful of the risk management techniques because it considers risks in normal operation as well as fault conditions. FMEA and FTA consider only fault conditions and are more suited as reliability tools than as product safety tools. We will explain how to integrate Human Factors studies into the Hazard Analysis and how to integrate Hazard Analysis into the design program. For more detail please click on this below link: http://bit.ly/2moVzlU Email: referrals@complianceglobal.us Toll Free: +1-844-746-4244 Tel: +1-516-900-5515 Fax: +1-516-900-5510

Overview In recent years, the health care industry has seen unprecedented levels of physician employment. Structuring employment arrangements appropriately and periodically auditing implementation are critical in today’s challenging enforcement climate. Why Should You Attend As health care organizations and physicians develop employment arrangements, they must manage their compliance and enterprise risk by ensuring the employment is defensible under the Stark Law. Prior to moving forward with any employment arrangement, the parties should carefully evaluate whether the proposed structure and financial terms support compliance with Stark’s technical requirements and key tenets of defensibility so they will be prepared to mount a defense in the event the arrangement is ever challenged. For more detail please click on this below link: http://bit.ly/2qCSqgA Email: referrals@complianceglobal.us Toll Free: +1-844-746-4244 Tel: +1-516-900-5515

This New ICH GCP E6 Revision 2 changes will cover those new requirements for running clinical trials, evaluate the changes and discuss how to implement these for sponsors, CROs and study sites. This session will enable you to meet the new international GCP standard to ensure the acceptance of clinical trial data by the regulatory authorities internationally including the European Union (EU), Japan, the United States, Canada and Switzerland.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/COMPLIANCE-ICH-GCP-R2-ADDENDUM-AUDITORS-505313/JUNE-2017-ES-TRAININGREGISTRY