Events
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The Online Seminar shows the Possibilities of the use of Desktop-Sharing Software. The Online-Seminar is free of charge an will contain the following topic. How to Setup the Software. The Webinar will held on request, the duration is approx. 30 Minutes Further Information to the Online-Seminar Learn more: www.practicepaysolutions.com/mastery Join us for a free series of one-hour webinars with the a team of industry experts! We're presenting the less-covered, critical issues for small business owners, so you can reduce the time you spend on set-up and administration-- and focus on what really matters. Can't attend live? We'll send you the call recordings so you can access valuable information and share the event with your community! April 2nd: The Joy of Productivity with George Kao April 16th: How to Create Profitable Referral Partnerships with Robert Notter April 24th: Say Bye-Bye to Your Boring Bio with Nancy Juetten May 15th: From Contacts to Contracts with Caterina Rando May 22nd: Red Fire Profitability with Liz Goodgold June 5th: Developing Contracts & Service Agreements with Tasha Cooper Coleman June 19th: Outsourcing Secrets with Travis Greenlee July 10th: Your Money Relationship = Your Business Success with Helen Kim July 24th: How to Play a Bigger Marketing Game with Fabienne Fredrickson Allan Gonsher and Kids Inc are pleased to a offer a series of Play Therapy Webinars. If your work with children, or want to work with children, these are workshops that you can not afford to miss. Each webinar workshop offers one hour of continuing education credit. Start: 06/06/2012 10:00 am
End: 06/06/2012 11:30 am
This 90-minute presentation will cover the FDA Quality System Requirements for software used in medical devices. The presenter will review FDA guidelines on software verification and validation and discuss methods to verify and validate even complex software. Software problems are now the third-leading cause for recalls of medical devices. Most recalls are because of incorrect verification and validation for safety. Most of the knowledge on how to do a comprehensive V&V is not widely understood. Software design is a complex set of interactions within the device, with the connecting devices, and with users of the device. Usually multiple factors affect the device performance. Therefore right validation is the key to prevent device recalls. This 90-minute presentation will cover the FDA Quality System Requirements for software used in medical devices. The presenter will review FDA guidelines on software verification and validation and discuss methods to verify and validate even complex software. Learning Objectives: Participants will learn
Start: 06/06/2012 10:00 am
Overview: The FDA's Quality System Regulation (QSR) prescribes the Quality Management System for a medical device manufacturer who markets in the US. ISO 13485 covers the rest of the world. The webinar describes management responsibility by reviewing the regulations and the reasoning that FDA published. Management responsibility, in QSR, has five major components: Quality Policy, Organization, Management Review, Quality Planning, and Quality System Procedures. The webinar covers each of these topics and provides a list of things you should consider in your implementation. Why should you attend: One of the most common areas for FDA Warning Letters is Management Responsibility. FDA considers this a principle subsystem and is where they start inspections. Ensuring that you understand what they expect and how to implement it is a valuable approach to preventing problems. More than that, however, a company can achieve tremendous value by setting up the FDA system. Effective management reviews, for example, can help your company identify opportunities for improvement, resolve issues, and make better products at lower cost. Quality plans and document structure outlines can help ensure you have covered all the requirements, i.e., no gaps, but that you haven’t duplicated effort or created redundant procedures. Areas Covered in the Session: Price List: webinars@globalcompliancepanel.com Phone: 800-447-9407 Start: 06/06/2012 10:00 am
Overview: This webinar is not a project management certification course. It is designed to provide the tools necessary to assist those designing a result or deliverable to achieve that end. It will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale. Three of the most common tools will be discussed. Common variants such as "dashboards" will also be presented. A very simple approach using common Excel- or Word-type PC applications programs that can be used immediately will be highlighted. Regular use of a few simple but powerful tools will virtually eliminate "fire fighting" in a new project. Regular use can contribute greatly to reduction of scheduling uncertainty, incomplete projects when time is running out, increased product liability, assist in company-wide cost reduction efforts, with less chance of recalls, and an improved bottom line. Why you should attend: The FDA expects companies to manage projects formally - to include regulatory requirements, design and/or change control, with consideration of all applicable standards. The EU MDD and their notified bodies are no different. How can this be done from a project's inception? How can a Project Leader or Project Manager ensure critical elements are not omitted until late in the project when disaster looms? How to minimize scope creep? What are the "lean" and "Agile" benefits and shortcomings in the cGMP environment? What is "failing fast" in the "build-measure-learn, re-evaluate / decide loop? How to gain management support for the Milestones, Tasks, and Timelines? Use the Plan as a powerful tool with FDA auditors. Use variations on these tools for any project, from the smallest to major company projects. These techniques are not rocket-science, but require the implementation of formal methods with documented and defensible rationale. Use these tools to bring predictability to your company's product development process. Use them to defend your remediation efforts with the FDA. Use them to prove "progress against plan". Areas Covered In the Session: Price List: webinars@globalcompliancepanel.com Phone: 800-447-9407 Start: 06/06/2012 10:00 am
End: 06/06/2012 11:00 am
This course will provide necessary information to those in the drug and device manufacturing industries on how to best work with consumers and health professionals regarding off-label claims of relevant drugs and devices that arise from third parties or from the natural progression of social media. Why Should You Attend: The government takes drug and device off-label promotion seriously. In the recent (May 7th) plea bargain by Abbott Laboratories, for unlawfully making off-label claims of its drug Depakot, the company agreed to pay $1.5 billion to resolve both the criminal and civil litigation. In another case in New York, an individual who was convicted of the crime of misbranding has raised a defence citing the Freedom of Speech under the First Amendment, but no decision has been announced by the court yet. The outcome may have a major impact on off-label promotions of drugs and devices based upon free speech. This webinar will help you in understanding how firms can develop procedures unique to them providing the most effective way to interact in social media affirmatively and positively in order to prevent the dialogue concerning their drug or device from being controlled by third parties, such as a competitor lurking behind a blog or webpage. We will also cover procedures to respond to independent and virtually non-regulated consumer social media that disseminate negative, off-label or controversial claims about their product over the Internet. You will learn how your firm can stay ahead of an ever-changing social media with pro-active information and not be exposed to the risk of additional FDA regulatory/enforcement activity and from a less positive view by the market. We will also discuss how and when to claim freedom of speech when working with off-label claims in the social media. Areas Covered in the Seminar:
Start: 06/06/2012 10:00 am
Overview: This webinar is not a project management certification course. It is designed to provide the tools necessary to assist those designing a result or deliverable to achieve that end. It will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale. Three of the most common tools will be discussed. Common variants such as "dashboards" will also be presented. A very simple approach using common Excel- or Word-type PC applications programs that can be used immediately will be highlighted. Regular use of a few simple but powerful tools will virtually eliminate "fire fighting" in a new project. Regular use can contribute greatly to reduction of scheduling uncertainty, incomplete projects when time is running out, increased product liability, assist in company-wide cost reduction efforts, with less chance of recalls, and an improved bottom line. Why you should attend: The FDA expects companies to manage projects formally - to include regulatory requirements, design and/or change control, with consideration of all applicable standards. The EU MDD and their notified bodies are no different. How can this be done from a project's inception? How can a Project Leader or Project Manager ensure critical elements are not omitted until late in the project when disaster looms? How to minimize scope creep? What are the "lean" and "Agile" benefits and shortcomings in the cGMP environment? What is "failing fast" in the "build-measure-learn, re-evaluate / decide loop? How to gain management support for the Milestones, Tasks, and Timelines? Use the Plan as a powerful tool with FDA auditors. Use variations on these tools for any project, from the smallest to major company projects. These techniques are not rocket-science, but require the implementation of formal methods with documented and defensible rationale. Use these tools to bring predictability to your company's product development process. Use them to defend your remediation efforts with the FDA. Use them to prove "progress against plan". Areas Covered In the Session: Price List: webinars@globalcompliancepanel.com Phone: 800-447-9407 Start: 06/06/2012 11:00 am
Discover multiple classes of antidepressants and how they are used inside and outside of treating depression. Full Description: Course Includes: What You Will Learn: Your Presenter: Disclaimer: Technical requirements: Who Should Attend: Start: 06/06/2012 2:00 pm
End: 06/06/2012 3:00 pm
A successful lead nurturing program can have a profound impact on an organization's bottom line. But where do you begin? Join OMI June 6 at 2pm ET for the complimentary class, "Top 10 Elements of Successful Lead Nurturing." You'll learn how to: - get buy-in from key stakeholders in both marketing and sales This class is a complimentary preview of the Online Marketing Institute's Marketing Automation Crash Course: A B2B Roadmap for Driving More Leads to Revenue (June 11, 2012 at 12pm ET). | ||
