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Courses

  • 61 Request Info

    Responsibility for Off-label Claims in Social Media

    FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform. If the information can reach a consumer, FDA cares, even if you did not publish the information. Firm's need to watch for promotional trespassers. Websites, chat rooms, op-ed articles or even your own postings in social media can cause your product to be misbranded, i.e., illegal. One big issue is how you patrol and control what someone else is saying about your product in a public forum. Once the off-label information is out there, what is scope your responsibility?
  • 62 Request Info

    Meaningful Quality System Process Monitoring

    When considering the requirements for process monitoring and measurement, the first thought is usually in regard to production processes. However, ISO 13485 and ISO 9001 require companies to monitor and measure all quality system processes. Too often, this is either ignored, considered to be addressed by internal audit, or focused primarily on cycle-time reduction; none of which actually address the intent of the requirements.
  • 63 Request Info

    Excel: VBA 101 -Automation Beyond the Macro Recorder

    Do you find yourself repeatedly performing the same actions or tasks in your spreadsheets? If the answer is "Yes", it's time to learn how to create a macro. VBA is the programming language that is built in to Excel (and the other applications in the MS Office Suite). VBA is used to automate tasks that would otherwise have to be performed manually by pressing keys and selecting items with the mouse -and if that sounds like a macro -well it is.
  • 64 Request Info

    Device Changes, FDA Changes, and the 510(k)

    The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". This is a major headache. How can companies make that determination? How can they trigger such an analysis over the major change or the series of smaller changes.
  • 65 Request Info

    Computer System Validation (CSV) for FDA-Regulated Computers

    The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines. This includes development of a company philosophy and approach, and incorporating it into an overall computer system validation program and plans for individual systems that are regulated by FDA. FDA’s guidelines for computerized systems were enacted in 1983, and very little has changed, other than technology, since that time, as it relates to validation.
  • 66 Request Info

    CAPA - BulletProof Per ISO13485: 2016

    Organizations should provide evidence that they have the required means and abilities to analyze failures and nonconformities, then set up corrections, corrective actions and corrective actions on duly manner. This webinar shall provide insight of how to establish CAPAs that shall provide the organization the confidence that the organization is mature enough to handle its own failures and avoid future nonconformities.
  • 67 Request Info

    Statistical Justification for Sample Size and the Use of Only 3 Lots

    This webinar explains how to choose and justify a sample-size for Lots that are included in Process Validation studies. The statistical methods discussed during the webinar include the following: Confidence intervals Confidence / Reliability Calculations (for variables & attributes) It then explains how to analyze those samples in such a way that they provide statistically valid final %Reliability for the production Process itself. One example is worked through completely.
  • 68 Request Info

    Risk Management in Medical Device Design

    Overview: The webinar will explore the basic principles of risk management and planning as they relate to medical device design and as required by the FDA. It will present a logical process for risk management from risk identification through evaluation/rating and mitigation. Why should you Attend: The secret to preventing medical device recalls or at least to minimizing their impact is sound Risk/Hazard Analysis. Aside from being required, it is absolutely essential and necessary to the development and fielding of medical devices that offer a significant level of protection for patients and manufacturers alike.
  • 69 Request Info

    Complying with FATCA - the Foreign Accounts Tax Compliance Act

    FATCA was enacted by Congress in 2010 as part of the HIRE Act. It attempts to restore tax fairness by focusing on foreign financial assets of US Citizens that are not being properly reported and taxed. With the announcement of final regulations in February, 2013, the US Department of the Treasury and the IRS have been busy designing, implementing and executing intergovernmental agreements, new and revised forms, and instructions to force US Citizens and foreign financial institutions into compliance.
  • 70 Request Info

    Create and Use Excel Dashboards to Gain Valuable Business Insights

    No matter what business you are in, a dashboard is a critical tool in your communication armoury and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel is commonly used due to its power, it's flexibility and the fact that most people have it installed on their computer. This training focuses on what you need to know to create an interactive professional-looking dashboard using Excel.
  • 71 Request Info

    Building a Better Quality Manual

    Quality Manuals are too often long documents that contain little more than a regurgitation of the standard requiring the manufacturer to have one. They end up being daunting to employees, confusing to everyone except those in Quality, difficult to maintain, and ultimately, a failure to meet the intent of the standard. In this webinar, attendees will learn to focus on the true intents and requirements for having a Quality Manual, and how to meet them efficiently.
  • 72 Request Info

    Implementation and Management of GMP Data Integrity

    Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both. To assure the quality of raw materials, in process materials and finished goods,laboratory data integrity is assuming greater importance in current Good Manufacturing Practices (CGMP) for US Food and Drug Administration (FDA)-regulated industry. Data integrity and security infractions are not only 21 Code of Federal Regulations (CFR) Part 11 issues but also severe CGMP violations.
  • 73 Request Info

    Accelerated Aging Techniques for Medical Device Packaging

    Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods. AA is used to estimate the useful lifespan of a product or its shelf life when actual lifespan data is unavailable. The ability of product designers to accurately predict changes in polymer properties is of critical importance to the medical device, consumer, and industrial markets.
  • 74 Request Info

    Verification vs Validation-Product, Process or Equipment and QMS Software

    The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.
  • 75 Request Info

    HIPAA Texting and Emailing: Do's and Don'ts

    Overview: This lesson will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to personal devices. I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors.
  • 76 Request Info

    Budgeting and Forecasting Physician Practices with Ease and Quality

    Overview: Strong budgeting and forecasting is about getting the fundamentals right. This webinar will teach you which areas to focus the majority of your time and effort in order to achieve the best results. Examples of high-quality detailed volume and physician compensation templates will be shown in order to illustrate the level of detail necessary to create a budget you will not be nervous to show your boss, banks, corporate office, or partners.
  • 77 Request Info

    Prolonged Service Codes

    Overview: Gain an understanding of the prolonged service codes that take place within health care and appropriately document what is needed. Prolonged service codes exist to allow for additional payment to the provider for time spent above and beyond typical times.
  • 78 Request Info

    Make your Job Easier, Understand What your CFO Expects

    Overview: During this hour you will begin to learn how to prepare and deliver financial information related to your department to the executives of your organization, and particularly the Chief Financial Officer (CFO). When explaining complicated phenomenon related to the operations or financial performance of your department the first 60 seconds is key. You will learn how to start the conversation in a way that leads to positive discourse, as well as the appropriate level of detail to include in your presentation. This webinar will also provide specific examples of the information your CFO expects you to regularly monitor so that you may know the answers to his questions before he even asks. When you can demonstrate to your CFO that you have control of your department's financial performance it makes both of your jobs far easier and can actually yield trust that reduces the level of scrutiny of your department.
  • 79 Request Info

    HIPAA and Having a Compliant Front Office

    In this 60 minutes webinar you can get everything you need to protect your practice from the most common front-desk HIPAA violations, Rhonda's session will help you ensure your front-desk staff are trained to identify violations before they get you in trouble, and successfully handle even the most challenging patient complaint.
  • 80 Request Info

    3-Hour Virtual Seminar on HIPAA vs. SAMHSA 42 CFR Part 2: Managing Disclosures when Substance Use Disorders are Involved

    In this webinar the latest guidance from the US Department of Health and Human Services on harmonization of SAMHSA and HIPAA will be explained, We will discuss what qualifies treatment that falls under SAMHSA, HIPAA allows a number of disclosures, for treatment, payment, and healthcare operations purposes, without consent from the individual being treated, also We will examine how to deternmine if the services you provide place you under 42 CFR Part 2.