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Courses

  • 41 Request Info

    SOP's for Bioanalytical Methods Validation

    Overview The webinar will include the following critical information you will need: Defining what a bioanalytical method is Necessary steps to validate an immunoassay The challenges and opportunities of validating a molecular assay Needs for mass spectrophotometry assays Issues in transitioning between assay classes Best practices for all bioanalytical methods
  • 42 Request Info

    FDA 21 CFR Part 11

    Overview This webinar will show you that there is no sense in tackling the 'keeping' of the records, by trying to follow Part 11, because the record requirements must come from the parties who provide, create, or change the records. If you are part of the process of 'Collecting' (e.g.: from study nurse to x-ray specialist), 'Using' (e.g.: from sponsor to report programmer, or statistician), or 'Keeping' (e.g.: from coder, software provider, to server and backup specialist), then this webinar will answer the questions: of how important your part is in this process, and how you can help the company safe resources and be compliant. If an effort is made to collect research-, study-, patient- or other important records, they should be kept safe, in a controlled and organized way. That way is defined by the requirements.
  • 43 Request Info

    FDA's New Import Program for 2019

    Overview The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information
  • 44 Request Info

    Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR

    Overview This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR). What the regulations mean is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation. It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.
  • 45 Request Info

    CAPA Simplified - A one-form, easy-to-complete, method for simplifying your CAPA process

    Overview This presentation will cover the FDA regulations (21 CFR Subpart J) regarding CAPA, how CAPA should be integrated into other branches of your Quality Management System, how to best approach CAPA (including initiation, evaluation, and follow-up verification), examples of documentation you can use to fulfill the CAPA requirement, as well as tips and tricks to what FDA auditors will look for when they come to visit your site.
  • 46 Request Info

    Secrets to Writing Effective SOPs for Medical Device QMS

    Overview Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed.
  • 47 Request Info

    FMEA & Risk Management for Medical Devices

    Overview FMEA (Failure Mode Effects Analysis) has long been recognized as a valuable tool in risk assessment and should be considered as an integral part of risk management. FMEA has been used as part of Risk Analysis under the obsolete standard EN 1441 -Risk Analysis for Medical Devices. The term "Risk Analysis" is no longer appropriate for medical device manufacturers and has been replaced by "Risk Management". EN 1441 is now a withdrawn standard and ISO 14971:2007 Medical Devices Application of Risk Management to Medical Devices has been the harmonized standard for risk assessment of medical devices under the medical devices directives and has been emphasized in the new ISO 13485:2016.
  • 48 Request Info

    ISO 13485 Quality Management System for Medical Device Industry, How to build a Quality Management System for the European Market?

    Overview Introduction, who should apply the ISO 13485:2016. Overview about the changes of the ISO 13485:2016. Explaining of each change. Smart and fast ways to implement the changes in your quality management system. Fast track internal audit to approve the changes.
  • 49 Request Info

    FDA's Gluten-Free Labelling Rule: How to Comply

    Overview The gluten-free market is one of the fastest growing markets worldwide. For the 18 million Americans who suffer from gluten intolerance, gluten sensitivity or celiac disease, gluten-free products are a necessity. To help assure customer confidence, the FDA issued a final rule on August 5, 2014, that defines gluten-free claims across the food industry.
  • 50 Request Info

    Managerial Primer for Ensuring Information Security

    Overview Usually, a formal ISG program is required to promote information assets safeguarding.ISG programs should ensure the Control Objectives for Information and related Technology (COBIT) framework confidentiality, integrity, availability, compliance, and reliability information criteria compromise does not occur through gaps in controls.
  • 51 Request Info

    Good Documentation and Record Keeping Best Practices (FDA & EMA)

    Overview Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified. This one-day workshop covers the essentials of GDP, its definition, purpose, and importance. Then expands on general rules and principles of GDP (US & EU), General tips for Laboratory Notebook documentation and finally discussing GDP enforcement by regulatory bodies in different countries with some examples of FDA citations and warning letters for different points presented in the session. In several occasions, group activities will be presented to find errors in documents based on the information provided in the class.
  • 52 Request Info

    Computer System Validation (CSV) for FDA-Regulated Computers

    FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards.
  • 53 Request Info

    Webinar on How to Use Social Media in Healthcare without Violating HIPAA Rules

    Learn how to use websites and social media for patient engagement in healthcare without violating HIPAA compliance. 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/HIPAA-Violations-Social-Media-Web-Sites-Patient-Reviews-Simple-Compliance-Steps-to-Avoid-Danger-508096/MARCH-2019-ES-TRAININGREGISTRY
  • 54 Request Info

    Webinar on The Problem of Bacterial Spores and Sporicidal Disinfection

    Learn the origins and risks of spores, strategies to reduce incidents and incorporation of sporicidal agents into the contamination control program. 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/The-Problem-of-Bacterial-Spores-and-Sporicidal-Disinfection-505059/FEBRUARY-2019-ES-TRAININGREGISTRY
  • 55 Request Info

    Seminar on Phase I GMPs

    Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs. More: https://www.globalcompliancepanel.com/seminar/seminar-on-phase-I-GMPs-901939SEMINAR/?SEO
  • 56 Request Info

    Webinar on Marketing to Medicare or Medicaid Beneficiaries - What You Can and Cannot Do

    Listen to this program to understand what you can and cannot do with regard to Marketing to Medicare and Medicaid Beneficiaries. Register for the webinar today. 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/Marketing-to-Medicare-or-Medicaid-Beneficiaries-What-You-Can-and-Cannot-Do-504719/FEBRUARY-2019-ES-TRAININGREGISTRY
  • 57 Request Info

    Webinar on Medical Director Contracting: Key Pitfalls to Avoid

    This presentation will discuss key compliance issues with respect to medical director contracts. More specifically, it will discuss the regulatory framework governing medical director contracts, key compliance issues, how to audit for medical director contract compliance, and recent government enforcement trends relating to medical director agreements.Price:$160.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Medical-Director-Contracting-Key-Pitfalls-to-Avoid-506752/SEPTEMBER-2018-ES-TRAININGREGISTRY
  • 58 Request Info

    Webinar on Compliance with the CMS Open Payments Rule (Sunshine Act)

    The CMS Open Payments Rule (sometimes referred to as the "Physician Payment Sunshine Act") was born out of the Affordable Care Act. This presentation will walk you through the requirements under the regulation and discuss the logistics and strategies for compliance. 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/Compliance-with-the-CMS-Open-Payments-Rule-Sunshine-Act-504674/AUGUST-2018-ES-TRAININGREGISTRY
  • 59 Request Info

    Webinar on FDA Reprograms Regulation of Mobile Apps Changes Direction

    FDA no longer regulates a number of medical apps that appear to present a low risk. Congress removed a huge group of medical apps from FDA's jurisdiction. This means firms must determine whether or not they have FDA regulatory obligations. FDA must revise its mobile app guidance to reflect the changes. In the meantime, mobile app developers and marketers should make a fair assessment as to how they can move forward, and in some cases free of FDA oversight. Caution: this does not mean that you are free of product liability. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/FDA-Reprograms-Regulation-of-Mobile-Apps-Changes-Direction-505099/AUGUST-2018-ES-TRAININGREGISTRY
  • 60 Request Info

    Webinar on 2018 OIG Work Plan for Coding, Billing & Reimbursement

    It is imperative that practices and facilities know the "audit risks" and what the Office of Inspector is looking for in regard to safeguarding federal dollars and protecting the Medicare trust fund. Discussion of what the audits have uncovered so far in 2018 and how you can protect your practice in the future. Easy to understand guidance and layout of the items that the OIG is watching. 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/2018-OIG-Work-Plan-for-Coding-Billing-Reimbursement-505323/AUGUST-2018-ES-TRAININGREGISTRY