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 Start: 08/22/2012 10:00 am
Overview: This webinar will evaluate medical device review routes under Exempt, 510(k) / PMN, and PMA, as both a process and as documentation / submissions. The 510(k) process and submission documentation, the role of the IDE, and the PMA process and submission documentation will be evaluated and discussed. The 21 elements of the 510(k). What is an IDE, and what is its format and role. The tailored FDA approach to the PMA. The broad range of U.S. FDA / regulatory issues to be considered by a company approaching the introduction of a new or changed device will be discussed, whether domestically manufactured or imported. How changes are addressed with each format. Such issues are taking on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do to "toughen" the new product review process -- all of which is being demanded by a public tired of on-going news of new product failures. A review of recent information from the Agency, as well Agency steps that have already been translated into action in the past two years will provide direction in areas of concern and what to expect in the future. Why should you attend: The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process, others are exempt, and some must go through the extremely costly, time consuming and rigorous PMA approval process. The FDA holds companies responsible for filing new 510(k)s, or IDEs / PMAs when new products are to be marketed in the U.S., or when existing products and/or their Indications for Use are changed. What are the steps and how are they documented? How is 510(k) vs PMA determined. What should be included, and what should only be referenced. What new concerns need to be addressed now? How can companies make such determinations? What approaches are required for product changes; for process changes? What about software "in-" or "as-product"? How does ISO 14971 Risk Management fit into the clearance / approval process? How to maximize the compilation process against scarce resources. Areas Covered in the Session: Who Will Benefit: John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA. Price List: Phone: 800-447-9407 webinars@globalcompliancepanel.com Start: 08/22/2012 10:00 am
End: 08/22/2012 11:00 am
This FDA Software Validation and Verification training/webinar will review the validation planning process with particular emphasis on avoiding six common pitfalls. Why should you Attend - FDA inspectors are now being trained to evaluate software validation practices. Start: 08/22/2012 10:00 am
JOIN US FOR WEBINAR ON WEDNESDAY, AUGUST 22, 2012 This one-hour, interactive webinar will show you how to improve your organization's bottom line by optimizing your license usage with License Statistics, one of the best license monitoring tools on the market. Reserve your seat now: https://www4.gotomeeting.com/register/553668023 If you have any questions, please contact us at info@x-formation.com. Start: 08/22/2012 10:00 am
End: 08/22/2012 11:00 am
This webinar will focus on internal controls models that you can adapt for your organization. It will cover the top 20 internal controls for fraud detection and prevention, and show how you can monitor them for effectiveness Description: Would your organization benefit from a best-in-class internal controls program that prevents fraud and avoids compliance fines? Internal controls should be an integral part of an organization and are designed to provide reasonable assurance of achieving: effective and efficient operations; reliability of financial reporting; and compliance with applicable laws and regulations. Internal controls also serve as the first line of defense in safeguarding assets, preventing and detecting fraud, and ensuring compliance. A decade ago, the Foreign Corrupt Practices Act (FCPA) , which bars American companies from bribing officials overseas, was rarely enforced or discussed. Today, it strikes fear throughout the executive offices of companies with overseas operations, generating huge fees for law firms and large fines for the federal government. The collapse of Enron a decade ago also led to tougher financial laws — including requiring top executives at publicly traded companies to certify that their companies’ books were accurate, forcing them to keep track of overseas money flows — and greater energy in enforcing them. Attend this webinar to learn how to implement better internal controls to detect and prevent fraud. We will also conduct a review of recent case study examples to help you understand what can go wrong. Why Should You Attend:
While Wal-Mart may be the most prominent company yet to get into trouble under the act, several specialists voiced doubt that any eventual fine would be nearly as large as some of the figures in other recent cases, which tended to involve huge procurement or oil deals. Such fines are generally calculated based on the amount of the bribes — the Wal-Mart case involves about $24 million — as well as the amount of ill-gained profit. That could turn on an analysis of whether the bribes merely sped up the opening of particular stores, or if they would never have been built if not for the graft. Event Details: Date: August 22, 2012 Start: 08/22/2012 10:00 am
End: 08/22/2012 10:00 am
This 2-hr webinar will provide a comprehensive overview of impurities in pharmaceutical products, that require to be controlled, and the strategies for controlling them. Why Should You Attend: A comprehensive 7-hr training is available on the same topic. Please click here to view the areas covered in that training. Learning Objectives: Start: 08/22/2012 10:00 am
End: 08/22/2012 11:30 am
Overview: This session covers the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States, as well as fully across all Member States of the European Union. This course specifically outlines and discusses the structure of the regulatory agencies at the EU-level and across specific Member States. Course content will explain which procedures are available for which products and then will follow the license processing steps for each pathway. Product examples will be discussed to illustrate effective filing techniques and when Full vs. Abridged applications will be required. The Course will link the requirements of the EU Clinical Trial Directive and discuss when existing clinical data might be sufficient to file. Related ICH compliant requirements such as GCP and GMP will enter the licensing approval process. Common issues that have caused difficulties for pharmaceutical firms will be discussed. Course content will explain how the EU interacts with national regulatory agencies and how companies can best address the conflicts that sometimes arise. Learning Objectives: This webinar is designed to provide an overview of the regulatory environment throughout Europe and will provide training in: Areas Covered in the Session: Who Will Benefit: For the past 9 years, Bob has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry. Price List: Phone: 800-447-9407 webinars@globalcompliancepanel.com Start: 08/22/2012 11:00 am
During this one-hour webinar, participants will gain valuable insight into stalking behavior and the reactions of stalking victims. Current research will be discussed as well as helpful resources for assisting victims of stalking. Full Description: Course Includes: What You Will Learn: Your Presenter: Disclaimer: Technical requirements: Who Should Attend: Start: 08/22/2012 12:00 pm
End: 08/22/2012 1:00 pm
Acclaimed career coach Kim Dority will lead this webinar hosted by Bryant & Stratton College Online. Ms. Dority is a frequent presenter for Bryant & Stratton College Online and has been writing about and teaching courses on career training for more than a decade. The "Make the Most of an Entry-Level Job" webinar will highlight tips and tricks for new graduates as well as prospective and current students. Attendees of the webinar will learn how to: Impress not only their boss, but their colleagues To learn more and register for the webinar, please visit: http://online.bryantstratton.edu/webinar/ Start: 08/22/2012 2:00 pm
Join OMI and Bizo Wednesday, August 22 at 2pm ET for the FREE webinar, "Digital Marketing on a Shoestring", and discover how SMB marketers can utilize online channels such as display advertising and social marketing to find and convert more of their target audience online and within budget. You Will Learn: -Why finding target audiences online can be difficult and how to overcome this challenge. | ||
