http://news.prlog.org/tag/compliance-training/compliance training - Latest News (Press Releases) - Read news before it's newsen-us3600 http://www.prlog.org/12117094-quest-ce-introduces-email-blast-utility.htmlBy utilizing client and industry feedback, Quest CE, premier provider of insurance continuing education and FINRA firm element training, built-out its most recent administrative feature, Email Blast Utility. http://www.prlog.org/12108168-quest-ce-introduces-data-bulk-load-utility.htmlQuest CE, premier provider of insurance continuing education and FINRA firm element training, is proud to announce the introduction of its high performance, data bulk load... http://www.prlog.org/12084311-trial-master-file-tmf-fda-expectations-from-sponsors-and-sites.htmlThe first document FDA auditors review during the audit of a clinical site is the Trial Master File (TMF). http://www.prlog.org/12084305-the-sunshine-act-reporting-for-clinical-trials.htmlPayments made to clinical investigators participating in clinical trials need to be disclosed to CMS under the Sunshine Act provisions of the Patient Protection and Affordable Care Act of 2010, generally referred to as Obamacare. http://www.prlog.org/12084303-meeting-the-fda-for-orphan-products-practical-strategies-to-maximize-benefit.htmlOrphan products have unique requirements for minimum testing to establish benefit to the target patients. http://www.prlog.org/12064316-quest-ce-offers-mobile-ready-ce-training.htmlQuest CE announced this week that its e-learning management system, Renaissance, is mobile-ready, making training and tracking attainable from any Internet accessible device. http://www.prlog.org/11097629-2013-quest-ces-year-in-preview.htmlAs we transition into the New Year, Quest CE, premier provider of insurance continuing education and FINRA firm element training, is excited to announce an overview of the services/upgrades that are to become available in first quarter, 2013. http://www.prlog.org/11889683-medical-device-risk-assessment-and-mitigation-through-fmea.htmlThis 90-minute presentation will discuss a structured way to mitigate risks with minimum cost. You will learn how to use FMEA to effectively estimate and assess risks in your medical device. http://www.prlog.org/12017326-simple-tips-for-reducing-the-crushing-cost-of-business-litigation.htmlFew things in business are more frustrating than when good people eat their words in court. For a limited time the Legal Leverage® Academy is offering a free video series with simple tips to push back unwanted liability and litigation. http://www.prlog.org/11995982-mid-state-hr-expands-names-director.htmlMid-State HR, a rapidly growing full-service human resources partner for companies of all sizes, has officially expanded to service the entire state of Virginia. Ronny Michelle Smith of Lynchburg, VA has been named Director. http://www.prlog.org/11978472-ind-submission-for-505b2-product.htmlA 505(b)2) product is an improved or altered version or a new use application for a previously FDA-approved drug. http://www.prlog.org/11978458-510k-submission-and-clearance.htmlA premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices. http://www.prlog.org/11961756-how-to-survive-dea-inspection-series-due-diligences-of-pharmacy.htmlThe public media has been reporting the fraud and abuse of narcotic dispensed for pain. http://www.prlog.org/11951476-fda-regulatory-control-of-the-drug-development-process.htmlWhen the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations. http://www.prlog.org/11928457-bankersedge-chooses-chartwell-compliance-as-new-service-provider.htmlBankersEdge is pleased to welcome new service provider, Chartwell Compliance. This partnership brings enriched compliance knowledge, and depth and breadth of experience to BankersEdge customers. http://www.prlog.org/11923549-how-to-survive-dea-inspection-series-dea-due-diligence-for-manufacturers-and-distributors.htmlDEA OFFICE OF DIVERSION CONTROL – familiarize the participant with the authority given to DEA when enforcing federal laws and regulations pertaining to controlled substances. http://www.prlog.org/11923436-the-role-of-lab-data-in-the-drug-development-process-adverse-events-subject-safety.htmlAll Clinical Research protocols have a prominent safety monitoring "plan" as part of the overall research plan / protocol. This "plan" is to ensure the safety of participating subjects and to ensure the validity and integrity of the data. http://www.prlog.org/11922895-510k-submission-contents-and-format-for-medical-devices.htmlA premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices. http://www.prlog.org/11883203-21-cfr-part-11-and-annex-11-compliance-specifics-needed-to-eliminate-483s.htmlThis 21 CFR Part 11 compliance training will guide you through the concept of part 11 and explanation of its 3 primary areas SOPs, Product features and Validation (10 step risk based approach). http://www.prlog.org/11883196-21-cfr-part-11-compliance-for-electronic-medical-records-webinar-by-complianceonline.htmlThis 21 CFR Part 11 training will analyze the regulations and provides concrete guidance on compliance for Electronic Medical Records. http://www.prlog.org/11837919-quest-ce-offers-their-social-media-representative-survey-free-of-charge.htmlQuest CE is offering their Social Media Representative Survey free of charge for firms and their registered representatives. http://www.prlog.org/11818804-how-to-establish-an-effective-good-clinical-practice-in-drugs-and-medical-devices.htmlThis 90-minute webinar will help you establish an effective Good Clinical Practice (GCP) by providing a current, accurate and complete (CAC) review and understanding of the relevant and applicable regulations for clinical trials or studies http://www.prlog.org/11789574-quest-ce-promotes-whitney-hagstrom-to-manager-of-business-development.htmlQuest CE, premier provider of insurance continuing education and FINRA firm element training, is proud to announce the promotion of Whitney Hagstrom to Manager of Business Development. http://www.prlog.org/11780719-changes-to-medical-records-how-to-manage-changes-and-meet-regulatory-requirements.htmlMedical Records serve many purposes in patient care so any revisions should only be done according to certain procedures and rules, in order to avoid serious compliance consequences. http://www.prlog.org/11775292-statistical-considerations-for-ich-guidelines.htmlThis unique hands-on course will provide attendees with an understanding of how to apply to Statistics to the ten ICH Quality guidelines. http://www.prlog.org/11775276-understanding-and-implementing-the-medical-device-directive.htmlThe instructor addresses the details of the MDD and includes other significant issues such as the Quality Management System (ISO 13485), Risk Management (ISO 14971), Clinical Evaluation (MDD Annex X), and the role of harmonized standards. http://www.prlog.org/11735477-us-eu-and-japan-gmp-requirements-practical-ich-area-differences-healthcare-authority-inspection.htmlThis 90 minute webinar will help you gain a detailed overview of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will help prepare you for regulatory inspections in these countries. http://www.prlog.org/11706746-quest-ce-introduces-anti-money-laundering-audit-assistance.htmlQuest CE is proud to announce the newest addition to its growing collection of Firm Element compliance training solutions, the anti-money laundering audit assistance tool. http://www.prlog.org/11705403-quest-ce-presents-quest-ces-correspondence-ce-training.htmlQuest CE's Correspondence CE Training allows firms to condense an agent’s state required, multi-hour course into just one hour. http://www.prlog.org/11665215-quest-ces-new-york-annuity-training-course-approved.htmlQuest CE is proud to announce their New York 4-Hour Annuities Training Course has been approved and satisfies Regulation 187 for the state of New York. http://www.prlog.org/11648548-practical-cost-effectivehands-on-approach-to-implementing-risk-and-internal-controls-from-mana.htmlThis unique hands-on course will provide attendees with risk and control concepts as well as deliver tools, templates and insight that will allow participants to immediately begin implementation within their organization/firm. http://www.prlog.org/11642670-live-webinar-excel-spreadsheet-compliance-with-21-cfr-11-byangela-bazigos.htmlThis course will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, http://www.prlog.org/11637041-live-webinar-on-hipaa-audits-and-enforcement-new-rules-new-penalties-and-new-audit-program.htmlEnforcement of HIPAA regulations is being stepped up and new fines and penalties make being ready for an audit in advance essential. http://www.prlog.org/11628945-quest-ce-introduces-compliance-consultant-programs.htmlQuest CE is proud to introduce Compliance Consultant Programs, the industry’s first fully integrated Firm Element Training and Tracking solution for compliance consultants. http://www.prlog.org/11624517-quest-ces-hawaii-annuity-training-course-approved.htmlQuest CE is proud to announce their Hawaii Annuities Training Course has been approved and meets the state’s annuity training requirements. http://www.prlog.org/11621406-how-to-design-capa-system-that-meets-and-exceeds-compliance-requirements.htmlThis webinar provides step by step instructions on how to design and manage a CAPA system that meets and exceeds compliance requirements http://www.prlog.org/11621400-why-pharmacovigilance-phase-iv-trials-will-be-increasingly-seenwhat-do-they-tell-us-and-why-are.htmlFDA-mandated post-market studies are coming. Phase IV studies are likely to be complex in design and large in scale (possibly 500,000 patients per arm), with exacting endpoints, and obligatory. The FDA appears to be abandoning a long-standing policy http://www.prlog.org/11611675-live-webinar-understanding-risk-management-in-medical-devices-by-jasmin-nuhic.htmlDuring the webinar, we cover topics and provide examples and share personal experiences related to FDA and ISO 14971, Risk Management Process, Risk Analysis, Risk Evaluation, Risk Control, Overall Residual Risk Evaluation http://www.prlog.org/11607714-how-to-secure-gcp-compliance-in-clinical-trials-the-complete-overview-of-the-critical-parameters.htmlThis GCP compliance in Clinical Trials training aims to provide an overview of the parameters critical in ensuring GCP compliance and in doing this, will translate GCP in a more practical, applied sense. http://www.prlog.org/11604220-applying-gmp-quality-principles-to-establish-reduced-testing-program-by-compliance2go.htmlThis webinar will discuss current regulatory and quality requirements for reduced testing of components used in pharmaceuticals and medical devices. Reduced testing will be viewed from current industry practice, the regulations, http://www.prlog.org/11604203-live-webinar-how-to-write-standard-operating-procedures.html"Attendees will recieve a complimentary e-book of " How to write standard operating procedures and work Instructions", published by the Instructor in 2010.The e-book will be send out to attendees after the webinar. http://www.prlog.org/11603824-how-to-prevent-or-handle-protocol-deviations-and-violations-to-be-gcp-and-regulatory-compliant.htmlIn this GCP compliance webinar learn how to prevent and handle protocol deviations and violations http://www.prlog.org/11601860-full-day-virtual-seminar-first-line-supervisors-human-resource-responsibilities.htmlThis 6 hour training course will cover areas of human resources for which supervisors are responsible, such as hiring, performance management, counseling, discipline, terminations http://www.prlog.org/11601853-beyond-incentives-how-to-motivate-employees-to-make-lifestyle-changes.htmlThis Employee Motivation training will demonstrate proven strategies for motivating employees to make lifestyle changes, improving employee engagement and wellness. http://www.prlog.org/11601841-full-day-virtual-seminar-compliance-in-executing-human-resource-policies-and-practices.htmlThis 6 hour training course will provide proactive measures and best practices for handling human resources policies and practices legally and effectively http://www.prlog.org/11599827-little-known-risks-of-personnel-files-webinar-by-complianceonline.htmlThis webinar will explain the different types of Personnel Files. Attendees will learn about the types of personnel files that need to be separated from other types, and those that require separate security measures. http://www.prlog.org/11599757-affirmative-action-and-the-ofccp-webinar-by-complianceonline.htmlThis OFCCP training will provide a comprehensive primer on affirmative action, its key principles, and current framework for developing compliant programs. http://www.prlog.org/11599740-child-support-garnishments-withholding-procedures-for-2011-webinar-by-complianceonline.htmlThis Child Support Garnishments training will help you understand the requirements to compliantly and effectively handle garnishment orders and withholding. http://www.prlog.org/11599689-hidden-hazards-in-writing-employee-handbooks-webinar-by-complianceonline.htmlThis webinar will explain the hidden dangers in writing an employee manual or handbook. Learn the Do's and Dont's and how to make its content binding on your employees. http://www.prlog.org/11597854-risk-analysis-without-fear-satisfying-hipaa-meaningful-use-requirements-for-privacy-and-security.htmlThis HIPAA risk analysis webinar will discuss how to go about a Risk Analysis for HIPAA, how to use Risk Analysis to prioritize your security efforts and how risk Analysis can help you win stimulus funding and avoid penalties.