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Courses

  • 1 Request Info

    Webinar On How to Apply for a Breakthrough Therapy Designation and Win It

    This webinar, presented by a leading regulatory affairs expert with successful BTDs, discusses FDA expectations from BTD requests, the best practices to write a BTD request, and pros and cons of applying for a BTD. The session will highlight key regulatory requirements, dos and don'ts, common areas of concern, and trouble-shooting BTD requests using case studies and examples from the presenter's vast experience helping companies big and small in successfully applying for a BTD.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/BREAKTHROUGH-THERAPY-DESIGNATION-504525/MARCH-2017-ES-TRAININGREGISTRY
  • 2 Request Info

    Webinar On Drug Safety and Pharmacovigilance: Effective Drug Safety Reporting and Surveillance

    This course provides a background to safety reporting. There is a refresher on the definitions and reporting requirements of AE, SAE, AR and SUSARs, within a clinical trial. We look at the sources of safety information and discuss the evidence that points to the causality of an event. The change in the regulatory environment is reviewed and the role of conditional approval and PASS and PAES studies is also discussed.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/DRUG-SAFETY-PHARMACOVIGILANCE-504550/MARCH-2017-ES-TRAININGREGISTRY
  • 3 Request Info

    Regulatory Compliance by Implementing the Cost Effectively

    Overview: This webinar will introduce and overview the concept of containing compliance costs - working smart. The webinar will provide a comprehensive strategy for cost reduction in regulatory affairs and compliance by presenting strategies for complying with FDA regulations in a cost-effective manner. Why should you Attend: What is the result or impact of the regulatory environment on the business? Companies find themselves in the position of doing too little or too much relative to compliance because they are simply not sure. Too little in terms of compliance makes you vulnerable to the FDA's auditing/checking function opening your company to a varying array of sanctions that could significantly impact your business.
  • 4 Request Info

    Analytical Method Validation in FDA process

    Overview: An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle. Why should you Attend: Observations that test methods are inadequate or the firm does not have appropriate data that demonstrates the method performs as intended rank high on the list of observations in the laboratory.
  • 5 Request Info

    Effective FDA and ISO Management Reviews

    Overview: In this presentation will cover the requirement for management review from FDA cGMP and ISO 13485 and approaches that can make these effective. Management review should be a key part of keeping your quality management system efficient and effective. Why should you Attend: Are your management reviews effective or do you have trouble getting senior management engaged? Perhaps you are not using an effective approach that fits your company or your management.
  • 6 Request Info

    How to Conduct a Human Factors - Test following ISO 62366q

    Overview: This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quantitative as is in device validation. Why should you Attend: We will explain how to choose the tests to be conducted and the studies that must be completed prior to the actual validation test. The post test participant inquiry is critical to validation success. we will describe how to do this.
  • 7 Request Info

    FDA Data Integrity for Computerized Systems: Combat the Misconceptions of 21 CFR 11 & Annex 11

    We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following: Evolution of 21 CFR Part 11 and Annex 11 and Why they are Back in the News Overview and Key Requirements of Part 11 & Annex 11 How to use a Risk Based Assessment to reduce work while still achieving Data Integrity and Compliance? How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity?
  • 8 Request Info

    Seminar on 21 CFR Part 11 compliance for software validation and SaaS/Cloud

    This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.
  • 9 Request Info

    Hazard Analysis following ISO 14971

    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. In this ISO 14971 risk management training we will explain in detail the process of conducting a hazard analysis. The confusing terms “hazard”, hazardous situation”, “harm”, “causative event”, “ALARP”, “risk index”, “residual risk” will be explained. We will go step by step through a template for hazard analysis so that the process is clear.
  • 10 Request Info

    2017 HIPAA Changes

    This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule, Trump administration, and any other applicable updates for 2017 and beyond.
  • 11 Request Info

    Effective Batch Record Review

    Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc. This webinar will analyze each of these necessary elements of the batch record review process.
  • 12 Request Info

    How to Deal With the Disruptive Practitioner

    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. 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. We will discuss the elements of an effective policy and the actions that should be taken to develop progressive discipline and/or sanctions that should be taken before taking action under the corrective action procedures.
  • 13 Request Info

    FDA and EMA Global labeling challenges faced in day-to-day operations

    Pharmaceutical companies must manage the process of designing and creating product labels that meet regulatory requirements. This includes product-labeling documents such as Packet Inserts (PIs), Summaries of Product Characteristics (SmPCs) and Core Data Sheets (CDSs). The large number of product strengths, dosage forms and product presentations results in a large number of labeling records that must be maintained and kept synchronized. The FDA and EMA are implementing a set of rules for the electronic submission of labeling content. The FDA labelling regulation requires companies to submit XML labeling content in Structured Product Labeling (SPL) format. The EMA labelling regulation requires companies to submit product information documents in QRD-compliant format.
  • 14 Request Info

    TrumpCare- How to Prepare and Be a Forward Thinker for Changes in Health care Reform

    A copy of two published articles on TrumpCare will be provided. A copy of the PPT will also be provided. Now that Trump is the President-Elect and on Feb 1, 2017 will be President of the USA; what will he repeal, reform or replace with Health Care Reform? Be prepared and find out now what you should be doing in 2017. We call this TrumpCare. Learn what should be in it and learn how to offer a cost effective health plan.
  • 15 Request Info

    Auditing Physician Contracts Under the New Stark Rules

    In this session Mr. Wolfe will provide an overview of the Stark Law, including its 2016 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. Healthcare reform has invigorated the government's focus on healthcare fraud, including enforcement of the Stark Law. Improper design and implementation of physician arrangements can result in penalties, denial of payments, and exclusion from federal health care programs. Thus, ensuring Stark Law compliance will be critical for medical groups, hospitals and health systems looking to manage areas of enterprise risk.
  • 16 Request Info

    Avoiding Critical R&D Formulation/Drug Delivery Errors

    We hopefully learn from our mistakes. But, it is far better to learn from other people’s errors and avoid them in the first place. In nearly 40 years of R&D in the pharmaceutical industry, I’ve made--and seen-- some doozies— technical errors, miscommunications, strategic planning oversights, and quite a few “political” blunders. Many, if not all, were preventable. All were costly! For example, over a multi-year period, our manufacturing plant had an occasional release-assay failure, for commercial heparin in intravenous bags. The plant did not consider it a serious problem because re-testing, with a larger sample size, nearly always was successful; the problem was attributed to assay-error and most of those lots were released. Suddenly, every batch failed. It was only then, that the Manufacturing Group got our R&D involved.
  • 17 Request Info

    Webinar On Avoiding and Preventing Embezzlement at Your Medical Practice

    A busy doctor is an easy target for embezzlement and in a down economy; a doctor may be even more at risk. The importance of educational, credit checks and drug screening will also be covered as well as practice policies and procedures implementation. Savvy embezzlers can fool even the most experienced employers, so learn how to protect yourself. Real life case examples will be discussed. "Tips to Protect Your Practice from Embezzlement" was published in The Journal of Medical Practice Management.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/EMBEZZLEMENT-MEDICAL-PRACTICE-504573/MARCH-2017-ES-TRAININGREGISTRY
  • 18 Request Info

    Webinar On Affordable Care Act Compliance and the 2017 Filing Season

    What needs to be considered for ACA compliance for 2016 and 2017? This webinar with Annette Nellen, CPA, GCMA, Esq. reviews the Premium Tax Credit (PTC) and the Individual Shared Responsibility Payment, as well as the new health reimbursement arrangement law enacted in December 2016. Ms. Nellen will address due diligence for preparers, and reminders for individuals and businesses, and resources to assist with compliance and planning.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/AFFORDABLE-CARE-ACT-COMPLIANCE-2017-FILING-509437/MARCH-2017-ES-TRAININGREGISTRY
  • 19 Request Info

    21 CFR Part 11 compliance for software validation and SaaS/Cloud

    Overview: • This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. • Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers.
  • 20 Request Info

    Webinar On How the FDA & FTC Regulate Advertising & Promotion of Drugs & Dietary Supplements

    This webinar will cover FDA regulatory compliance requirements for all manufacturers and distributors who want to advertise and/or promote OTC drugs and dietary supplements in the U.S. The relationship between FDA and the FTC will be covered. Guidance will be provided on how to advertise OTC drugs and dietary supplements while avoiding misleading or unsubstantiated claims.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/FDA-FTC-REGULATE-ADVERTISING-509777/MARCH-2017-ES-TRAININGREGISTRY