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  • 1 Request Info

    Webinar On Harmonized System Classification Basics, General Rules and Sections Content: Webinar Series

    All companies involved in international trade must understand the importance of determining the correct Harmonized Tariff Schedule provision for imported and exported products. The HTS is also used to determine whether goods are subject to "other agency requirements," quotas, or free trade agreements. U.S. Customs expects companies to use reasonable care and correctly classify its imported products at the time of entry.Price:$600.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/HARMONIZED-SYSTEM-CLASSIFICATIOIN-SERIES-509908/MARCH-2017-ES-TRAININGREGISTRY
  • 2 Request Info

    Webinar On Harmonized System Classification: Basics

    The Harmonized Tariff Schedule is an international customs classification system. It was developed by the World Customs Organization as a tool to facilitate the world trade by creating a nomenclature that assures uniformity in its application, and at the same time address domestic issues. Not only it is used to establish tariffs and duties, but also to implement measures to protect the public health, the environment, the wild and the world safety. It has been in force since 1988. It is used for 90% of the trading world.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/HARMONIZED-SYSTEM-CLASSIFICATION-509007/MARCH-2017-ES-TRAININGREGISTRY
  • 3 Request Info

    Webinar On Classifying Medical Devices - US and EU

    This webinar will detail the medical device classification process for the United States through the FDA and will overview the very complex process for medical device classification within the EU. Specifically, this webinar will provide detailed background into the process and will make clear some of the very complex terms and sub-processes associated with medical device classification. We will actually work through the classification process step-by-step for the US and will overview how the process is accomplished for 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/CLASSIFYING-MEDICAL-DEVICES-505796/MARCH-2017-ES-TRAININGREGISTRY
  • 4 Request Info

    Webinar On Telehealth: Understanding JCAHO Standards and Legal Regulatory Compliance

    This course will cover the legal and regulatory aspects that impact organizational compliance and that which maintain practitioner compliance standards relative to the delivery of inpatient and outpatient telehealth services.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/JCAHO-STANDARDS-LEGAL-REGULATORY-COMPLIANCE-508848/MARCH-2017-ES-TRAININGREGISTRY
  • 5 Request Info

    Webinar On The new Food Concern Spectrum: Food Authenticity

    While the concerns over food fraud trend after notable events, this webinar steps up into a higher elevation approach to the issue. Food Fraud is one of five key areas of food concerns under the umbrella of food authenticity. The list of concerns includes: Food Quality, Food Safety, Food Fraud, Food Defense, and Food Security. This course will help attendees understand the specific risks for each of the five concerns and how they are different from each other.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/FOOD-AUTHENTICITY-502280/MARCH-2017-ES-TRAININGREGISTRY
  • 6 Request Info

    The Most Common Coding Errors and How to Avoid Them

    There is a wealth of information outside of the CPT manual that is necessary for the coder to perform his or her job correctly. These are conceptual an organizational points that every coder must have a firm grasp of additionally we will look at some of the most common coding examples and resources for further information.
  • 7 Request Info

    Pharma Analytics – I Have All These Data, Now What Do I Do?

    We know that it takes more than a large data set and computer software to effectively solve problems. As information technology increases in capability and availability the opportunity to use data to develop and improve processes becomes even greater. Particular attention is paid to the pedigree of the data: the process that generated the data, the measurement process and the data collection process including the sampling schemes used. Also essential to success is the use of subject matter knowledge to frame the problem and assess and interpret the results of the analysis.
  • 8 Request Info

    Countdown to MACRA: It's Time for Physicians to Pick Their Pace for 2017

    On October 14th CMS published the final rule that outlines its implementation of MACRA value-based payment reform starting in 2017. The new framework is called the Quality Payment Program. Going forward, clinicians and health care leaders need to be developing strategies so they can position their organizations for financial success under the new Quality Payment Program. Beginning in 2017, CMS will start rewarding clinicians for their delivery of high-quality patient care through one of two pathways: (1) payment of incentives for participation in Advanced Alternative Payment Models (Advanced APMs); or (2) application of a positive or negative adjustment pursuant to the clinician's performance under the new Merit-based Incentive Payment System (MIPS).
  • 9 Request Info

    Workshop On Post-Compliance Medical Device Regulations and Evolving Reporting Requirements: Complaint Handling, Medical Device Reporting/ eMDR and Rec

    Medical Device Reporting (MDR) and the implementation of the Final Rule on eMDR and recall compliance are critical to the continued survival of all device manufacturers. The FDA is continuing their efforts to issue numerous FDA Warning Letters and serious enforcement actions, including criminal & civil penalties levied on companies that failed to properly report events and take proper corrective and removal actions. Ineffective or lack of proper Complaint Handling is cited as one of the top violations in a 483 issued at time of inspection by FDA. Price:$1400.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/workshop/POST-COMPLIANCE-MEDICAL-DEVICE-800020/MARCH-2017-ES-TRAININGREGISTRY
  • 10 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
  • 11 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
  • 12 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.
  • 13 Request Info

    Differences between ISO 13485 2015 versus ISO 13485 2003

    Overview: The webinar will first present the key differences between ISO 13485 2015 versus ISO 13485 2003.Next, the speaker will provide an overview of the updated standard. Why should you Attend: This webinar is an overview of the coming changes and their implications, using a new approach yet is based upon solid principles and proven practices.
  • 14 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.
  • 15 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.
  • 16 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.
  • 17 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?
  • 18 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.
  • 19 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.
  • 20 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.