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  • 1 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
  • 2 Request Info

    Webinar On Medical Device Premarket and Post market Cyber security following the new FDA Guidances

    Medical devices, like other computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. This vulnerability increases as medical devices are increasingly connected to the Internet, hospital networks and to other medical devices. This webinar will describe a program that will minimize risk to the user from cyber attacks.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/MEDICAL-DEVICE-PREMARKET-POST-MARKET-CYBER-SECURITY-509863/MARCH-2017-ES-TRAININGREGISTRY
  • 3 Request Info

    Webinar On MACRA Performance and the Role of Chronic Care Management Services: Meeting the MACRA Requirements while Boosting Revenue in your Practice

    This course will review the components of the Medicare Access and CHIP Reauthorization Act (MACRA) that overlap with the Medicare Chronic Care Management (CCM) initiative. The two program overlap in several ways and are complimentary. Engaging in both programs will allow practices to improve MIPS scores and achieve Advanced APM objectives while generating additional revenue from the CCM program.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/MACRA-PERFORMANCE-REQUIREMENTS-501936/MARCH-2017-ES-TRAININGREGISTRY
  • 4 Request Info

    Medical Devices Industry and Risk Management 2017

    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=900888SEMINAR?channel=mailer&camp=Seminar&AdGroup=austinmonthly_April_2017_SEO
  • 5 Request Info

    Conducting Internal Investigations 2017

    t seems that employees love to complain about anything, and it seems impossible to investigate everything. When employees feel, however, that you are not taking their complaints seriously enough or that you are ignoring them, they will find external sources for their complaints. These external sources range anywhere from the EEOC, the NLRB, Wage and Hour, private attorneys, and juries!! And juries love to punish you when they feel that you ignored an employee's legitimate complaint. But what are legitimate complaints? We all know that an employer has a legal responsibility to investigate some complaints but not others. Can you make the distinction? How you handle internal complaints can make all the difference of whether an employee goes externally with their complaints. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900872SEMINAR?channel=mailer&camp=Seminar&AdGroup=austinmonthly_April_2017_SEO
  • 6 Request Info

    Leadership Management Academy 201-202: Rising Through the Management Ranks 2017

    Why Should You Attend? By attending, you will take advantage of a great opportunity to advance as a manager to the next level! Too often, we focus on getting things done and results and miss working on our self-development. Let's face it: this is how we get paid yet this is also how we keep falling behind when it comes to our careers. It's time to get ahead! Don't miss an opportunity to advance as a manager again! We'll take you through peer discussions addressing leading and managing, integrating finance and quality, managing your time effectively, managing performance and managing up. Join us as we help you report back to your manager that "I'm ready to take the next step in advancing my management career!" Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900866SEMINAR?channel=mailer&camp=Seminar&AdGroup=austinmonthly_April_2017_SEO
  • 7 Request Info

    Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals 2017

    This workshop style training course is designed based on 30 year of regulatory affairs experience in preparing more than 150 successful U.S. FDA submissions for major medical device companies. In these 2 days, the following essential elements of U.S FDA premarket submissions will be covered: History and background of U.S FDA Laws and Regulations Classify Your Device Choose the Correct Premarket Submission for your device Compile the Appropriate Information for your Premarket Submission Author and Prepare your Premarket Submission Submit your Premarket Submission to the FDA Interact with FDA Staff during Review and Approval Complete the Establishment Registration and Device Listing Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900778SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 8 Request Info

    Implementing ISO 13485:2016- 2017

    The final version of ISO 13485:2016 is now available and companies should be planning their implementation. There are significant changes from the earlier version; they will require major modifications to the Quality Management System (QMS). The new version has better alignment with FDA's QSR, but there are still major differences that create issues for effective QMS implementation. This workshop covers the differences from the 2003 version to the 2016 version and offers practical implementation advice to update your QMS. Participants will also learn the differences with QSR and understand how to resolve them. The workshop uses extensive examples and exercises to help clarify the concerns. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900766SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 9 Request Info

    Overview of Device Regulation – FDA 2017

    This course provides a basic description of an FDA regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful strategies for medical devices, including definitions and classifications, elements of regulatory strategy, sources of regulatory intelligence, selection of development and product clearance/approval pathways. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900900SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 10 Request Info

    Common Frauds: Creating and Improving Anti-Fraud Controls for Businesses 2017

    This course will address the risks to a business from data breaches, various forms of cyberfraud and identity theft. We will discuss the legal issues with data breaches including issues for companies that are victims of data breaches. We will review the best practices for data security. Attendees will be given examples of cyberfrauds, including information on how they occur and internal controls that can help to prevent them. The new requirements for IT controls included in the 2013 COSO update will be discussed. The types of identity theft and methods used by criminals will be discussed, also how individuals and businesses can protect themselves from identity thieves. The new credit card rules will be reviewed. The compliance requirements of the Federal Trade Commission's Red Flags Rules will be reviewed. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900862SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 11 Request Info

    Applied Statistics for FDA Process Validation 2017

    In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production.." The guidance further delineates the 'process design stage through commercial production' into three distinct stages of the product lifecycle: Stage 1: Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities. Stage 2: Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900806SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 12 Request Info

    Writing and implementing effective SOP's 2017

    An SOP is a meticulous step-by-step description of how to do a task that leave no chance for errors and divergence. Writing a good SOP is not an easy job. It requires a firm understanding of the task to be described, an ability to describe in specific unique to that laboratory. Writing, implementing, maintaining and assessing, revising an SOP are all different and necessary jobs. Many people must continuously be involved in these steps. Even a standardized method, such as an ASTM or IP method, is insufficiently written to pass as a well-written and compliant SOP. The reasons why will be described, as will the steps needed to convert a standard method into an SOP Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900912SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 13 Request Info

    Introduction to Industrial Statistics 2017

    This is an introductory course in industrial statistics that will equip the attendee to understand what he or she needs to know about basic descriptive statistics such as measurements of central tendency (average) and variation (range and standard deviation), and to use graphical methods such as the box and whisker plot to visualize these statistics for data sets. The concepts of variation and accuracy, and their effects on outgoing quality, will be introduced at the beginning. The basic data visualization tools of the histogram and Pareto chart also will be presented. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900904SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 14 Request Info

    Quality by Design - Essential Techniques for Medical Devices 2017

    Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet, Design Controls are still one of the most frequent areas for 483 and Warning Letter observations. This 2 day seminar will help you understand, develop, and implement design controls processes and tools that are a competitive strength for your company. You will learn how to incorporate design controls into your product development process to help streamline development and ensure quality and compliance. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900852SEMINAR?channel=mailer&camp=Seminar&AdGroup=austinmonthly_April_2017_SEO
  • 15 Request Info

    Preparing to Comply with the New FDA FSMA Rules: Planning Valid Preventive Food Safety Controls 2017

    Upon completing this course participants will leave with a preliminary preventive control implementation plan and will: Understand US FDA final rules for the Preventive Controls for Human and Animal Foods Define and review your current system to identify gaps in your preventive controls planning. Be able to develop and implement a valid preventive control company food safety plan to close any gaps Write and implement appropriate procedures. Know your requirements for control over your supply chain Be able to plan and implement HARPC Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900814SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 16 Request Info

    HIPAA Training Programs 2017

    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 2017 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. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900786SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 17 Request Info

    How to build a complete Safety, Health & Environment Management System through Standards & Practices 2017

    A management system, by definition, is a process by which a function or functions are carried out in an organization by a series of hierarchal documents that are prescriptive, and set a particular path on which the organization manages its day-to-day operations. A management system can be for one function, but more often than not, it incorporates many functions. Functions like accounting, engineering, banking, etc. have their own management systems, and the Safety, Health and Environmental, as well as Training and Security should have their own management system. This brings efficiency, consistency, cost effectiveness and timeliness to the entire process. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900844SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 18 Request Info

    Quality by Design using Design of Experiments (QbD) 2017

    This seminar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles using design of experiments (DOE). In addition, this course teaches the application of statistics for setting specifications, assessing measurement systems (assays), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product quality system framework defined by requirements in regulatory guidance documents. Using a QbD approach for pharmaceutical development studies should include a systematic understanding of the process and using this understanding to establish a control strategy as part of a comprehensive quality risk management program. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900802SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 19 Request Info

    Why is FDA at my facility, and what do I do during an inspection 2017

    Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900762SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 20 Request Info

    The Complete Payroll Law and Best Payroll Service 2017

    This course covers a very broad range of topics from worker classification, to employee classification, to establishing methods and rates of pay, what must be included in the rate of pay, hours that must be compensated as worked time, required benefits, de minimus working fringes, withholdings and deductions from pay, voluntary deductions, child support and garnishment orders, payroll reporting, analysis of risks of noncompliance, proper documentation of your policies and procedures and record retention requirements. We will show where to find the laws, how to interpret them and how to apply them in the most effective ways. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900840SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO