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  • 1 Request Info

    Webinar on An Update on Discharge Planning Rules and Regulations for 2018

    This program will review the current rules and regulations from the Conditions of Participation for discharge planning. We will then discuss the most recent changes from the Medicare program and how they will impact the roles of the RN case manager and the social worker. We will review strategies for safely transitioning your patients across the continuum of care.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/An-Update-on-Discharge-Planning-Rules-and-Regulations-for-2018-509438/JANUARY-2018-ES-TRAININGREGISTRY
  • 2 Request Info

    Webinar on Understanding the Decision Points of Self-Disclosures and Repayment Obligations

    This presentation will provide a general overview related to the process of disclosing self-identified Medicare overpayments. More specifically, it will walk attendees through the current regulatory framework governing reporting and returning obligations. Additionally, discussion will also include insights on how to conduct an internal review and the decisions involved such as determining when to report and where to disclose. 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/Understanding-the-Decision-Points-of-Self-Disclosures-and-Repayment-Obligations-508157/JANUARY-2018-ES-TRAININGREGISTRY
  • 3 Request Info

    NDAs and INDs for Orally-Administered Drug Products

    Overview: This webinar will be helpful to applicants conducting BA/BE studies during the IND period, also FDA guidance recommendations on how to meet the BA and BE requirements in 21 CFR 320 as they apply to oral dosage forms. Why should you Attend: Understanding when Bioavailability and Bioequivalence studies should be done can help attendees avoid having to re-do clinical trials, help to determine dosage regimen that achieves target drug exposure.
  • 4 Request Info

    Learn Some of the Acceptance Activities in FDA QSR

    Overview: This section plays a major role in both purchasing and in production. It is a major contributor to determine whether your supplier and manufacturing process are working effectively. Why should you Attend: As you ensure that your Quality Management System meets FDA's regulations, you need robust acceptance activities. A gap could result in a Warning Letter, but even worse, it could also create a recall. This presentation provides the implementation information as well as the audit strategy to help verify your processes.
  • 5 Request Info

    Underutilized and Underappreciated in Management Control

    Overview: In the highly regulated medical device industry, management responsibility and management review are critical concepts in ensuring a suitable Quality Management System (QMS). Why should you Attend: Management with executive responsibility is responsible for establishing a quality policy and objectives and for demonstrating a commitment to quality. And management at all levels should be aware of and engaged in quality efforts and customer focus.
  • 6 Request Info

    Practices for Active Pharmaceutical Ingredients per ICH Q7

    Overview: The APIs covered in this guidance document include new chemical entities and APIs of biological origin and those created by biotech processes. Why should you Attend: This document was created to fulfil the need for specific guidance with regards to GMPs for APIs. Failure to meet these requirements is a significant source of observations during regulatory inspections by FDA or global regulators of manufacturers and/or of sponsors that use contract manufacturers and the contract manufacturers themselves.
  • 7 Request Info

    How to Compliance with SaaS/Cloud Software Applications

    Overview: It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance. Areas Covered in the Session: Which data and systems are subject to Part 11 and Annex 11 What the regulations mean, not just what they say Avoid 483 and Warning Letters Requirements for local, SaaS, and cloud hosting SOPs required for the IT infrastructure
  • 8 Request Info

    Statistics for Data Science | Medical Statistics Course 2018

    If statistical analysis is not properly performed and/or understood, a firm can run the risk of distributing the kind of product to the market that ultimately fails, resulting in lost time and money. Statistics of course, requires constant practice. This seminar will be highly interactive and participative. Participants apply their learning of statistics to real-world example data sets. The program begins by providing a basic overview of the most common statistical tools and terms. By the end of day two, course participants will have acquired the skills necessary to read and understand statistical reports contained in the CMC section including statistically sound sampling plan. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901474SEMINAR?trainingregistry-February-2018-SEO
  • 9 Request Info

    Human Factors Psychology Graduate Programs | Human Factors 2018

    The ISO 62366 is an "Consensus" Standard, making it a gold standard for regulatory submissions. We will look at other reference points regarding HF, like AAMI/ANSI HE75:2009 and how HF Engineering include consideration of: Device Users Use Environments and User Interfaces Preliminary Analyses Exploratory HF/Usability Evaluations Hazard Mitigation and Control We will look at the implication of HFE through Design Controls in the QSR: Design input -includes "needs of the user and patient" Design validation - "... devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901501SEMINAR?trainingregistry-February-2018-SEO
  • 10 Request Info

    Quality Management System Courses | Quality Professionals 2018

    Many companies struggle to establish and maintain a Quality Management System (QMS) that is both efficient and effective. An ineffective QMS leads to disastrous consequences such as medical device reports, recalls, 483s, and warning letters. An ineffective QMS can result in serious consequences for your customers leading to dissatisfaction, serious injury, or even death. It is imperative that medical device companies can effectively establish a QMS. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901489SEMINAR?trainingregistry-February-2018-SEO
  • 11 Request Info

    What is Data Integrity Issues-Types of Data Integrity Issues 2018

    Defined by the Medicines and Healthcare Products Regulatory Agency (MHRA) as "the extent which all data are complete, consistent and accurate throughout the data lifecycle", data integrity is increasingly the focus of regulatory agencies round the world. Companies must now ensure that they are appropriately addressing data integrity and data governance. This includes organizational, procedural and technical controls that must be considered as part of an overarching data governance system. In addition, the effort and resources committed to data integrity must be commensurate with the role it plays in assuring product quality. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901378SEMINAR?trainingregistry-February-2018-SEO
  • 12 Request Info

    Risk Management Education Course | Medical Devices Industry 2018

    Gaps, incorrect or incomplete implementation of software can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical device software in a regulatory compliant environment. Software risk management has to be embedded into the bigger scope of overall risk management. Therefore this course will additionally address the system level risk management and the resulting interfaces to software. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901459SEMINAR?trainingregistry-February-2018-SEO
  • 13 Request Info

    FDA Import Process | FDA Food Facility Registration 2018

    FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained or refused. As of December 2016, FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You either meet ACE requirements or face entry refusals and monetary penalties of up to $10,000 per offense. Other factors can derail the expectation of a seamless import entry process. The course covers detailed information about the roles and responsibilities of the various parties involved with an import operation and how to correct the weakest link(s) in the commercial chain. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901399SEMINAR?trainingregistry-February-2018-SEO
  • 14 Request Info

    EU Clinical Trial Regulation Implementation | Regulatory 2018

    This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Directive and the impending changes coming to the EU through the EU Clinical Trial Regulation (for Drugs, Biologics & Combination Products). The course also covers recent updates on EU-GCP associated with the new regulatory framework, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators. Additionally, the seminar will cover the impending changes coming with the EU Parliament passage of the EU Clinical Trial Regulation, which will affect all trials conducted across the EU [new and ongoing]. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901354SEMINAR?trainingregistry-February-2018-SEO
  • 15 Request Info

    HR Auditing: Identifying and Managing Key Risks

    HR audits are designed to help your organization focus its attention on its human resource management practices, policies, procedures, processes, and outcomes by providing you with a structured and systematic series of questions about key compliance, risk management, internal auditing, and human resource management issues. As a process, HR audits are designed to help your organization identify potential and actual problem areas, help assess the effectiveness of current HR management activities, help assess weaknesses in HR internal control processes, and help assess human capital strategic and compliance related risks. HR audits should additionally provide suggestions for corrective action. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901198SEMINAR?trainingregistry-February-2018-SEO
  • 16 Request Info

    HIPAA Compliance Officer Training | HIPAA Professional 2018

    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 and any other applicable updates for 2018 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days. I will speak on specific experiences from over 17 years of experience in working as an outsourced compliance auditor, expert witness on multiple HIPAA cases, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information. More importantly I will show you how to limit those risks by simply taking proactive steps and utilizing best practices. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901507SEMINAR?trainingregistry-February-2018-SEO
  • 17 Request Info

    Why Measure Drug Plasma Levels | Drug Dissolution Testing 2018

    Drug dissolution testing is an essential and critical step for appropriate and efficient product development such as tablet and capsule. A number of approaches are used to conduct dissolution testing using different apparatuses and methods. Making a choice for an appropriate apparatus and method has always been confusing and challenging. This seminar will provide relevant pharmacokinetics and physiological background so that making this choice becomes easier and instinctive. No prior knowledge of pharmacokinetic and/or physiology is required; however, these will be explained in very simple terms to help attendees in selecting or developing a dissolution method. This seminar will describe in detail the theoretical aspect of the drug dissolution testing including method development. Pros and cons of different approaches will be explained in detail. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901498SEMINAR?trainingregistry-February-2018-SEO
  • 18 Request Info

    Medical Device Registration and Listing | Japan, Australia

    Classification systems differ from that of the United States or European Union in select countries Medical devices are classified depending on their risk level Medical devices must also comply with additional country standards and these standards define industry-wide safety and performance requirements Regulatory registration process is defined for China, Hong Kong, India, Japan, South Korea, Taiwan, Singapore and Australia The regulatory process from product design to market entry for a new medical device or IVD is oftentimes complicated and unclear. In Asia Pacific, it can become difficult to make a clear distinction between your regulatory strategy and business strategy. And Much More... Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900990SEMINAR?trainingregistry-February-2018-SEO
  • 19 Request Info

    Importance of Dissolution Testing | Plasma Levels of Drug 2018

    Drug dissolution testing is an essential and critical step for appropriate and efficient product development such as tablet and capsule. A number of approaches are used to conduct dissolution testing using different apparatuses and methods. Making a choice for an appropriate apparatus and method has always been confusing and challenging. This seminar will provide relevant pharmacokinetics and physiological background so that making this choice becomes easier and instinctive. No prior knowledge of pharmacokinetic and/or physiology is required; however, these will be explained in very simple terms to help attendees in selecting or developing a dissolution method. This seminar will describe in detail the theoretical aspect of the drug dissolution testing including method development. Pros and cons of different approaches will be explained in detail. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901495SEMINAR?trainingregistry-February-2018-SEO
  • 20 Request Info

    Webinar on CMS's OPPS and PFS Final Rules for CY 2018: Key Provisions and How They Impact Your Organization

    An overview of the changes that will be occurring under the CY 2018 OPPS and PFS Final Rule. How these changes impact APC (Ambulatory Payment Classifications) and their payments. What Key provisions are present and how they will impact your facility. New Challenges for Hospitals in quality of care requirements and coding.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/CMS-s-OPPS-and-PFS-Final-Rules-for-CY-2018-Key-Provisions-and-How-They-Impact-Your-Organization-506081/DECEMBER-2017-ES-TRAININGREGISTRY