This webinar will provide valuable assistance and guidance to device companies in involved in commercialization of combination products. What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product? Determine which Center will review my combination or non-combination product? These topics and more will be addressed during this Webinar, including recently FDA's proposed rule to codify the current good manufacturing practice (cGMP) requirements applicable to combination products.
Date : Thursday, July 28, 2011 Live Webinar Time : 10:00 AM PDT | 01:00 PM EDT Combination Products: FDA's Proposed Duration : 60 Minutes Rule for GMP Requirements and Introduction and Expectations for Price : $245.00 "Combo" Products Overview: This webinar will provide valuable assistance and guidance to device companies in involved in commercialization Register Now of combination products. Instructor Profile: What is a combination product? What are some examples of David R. Dills combination products? How are combination products Industry Regulatory & assigned for review? Where can I find guidance for how Compliance Consultant master files can be used in the submission of information David R. Dills, an independent relevant to my combination product? Determine which Center Regulatory & Compliance Consultant will review my combination or non-combination product? with more than 22 years of hands-on These topics and more will be addressed during this Webinar, experience and a proven track including recently FDA's proposed rule to codify the current record within the FDA regulated good manufacturing practice (cGMP) requirements applicable industry, has an extensive to combination products. regulatory and compliance background with Class I/II/III and Areas Covered in the Session: IVD devices and managing and handling activities within the global l Introduction to Combination Products if you design, regulatory and compliance develop, produce, distribute and deploying a landscape. He manages quality, sustainable regulatory strategy regulatory and compliance projects l Description and explanation of FDA's proposed rule with multiple competing priorities l Requirements for Single-Entity and Co-Packaged having a direct impact on site Combination Products operations and commercial l Identify requirements that apply to the constituent opportunities and develops parts of a Combination Product before they are strategies for governmental approval combined, or packaged together to introduce new products to market, l What current good manufacturing practice provides guidance and direction on requirements apply to my combination product? regulatory and compliance l Learn FDA's new terms and phrases requirements and prepares/reviews l Understand how to address a Request for Designation worldwide for a combination or non-combination product and submissions/dossiers/technical files examples of “combo” products and addresses requirements in the l Resources and guidance to help define a proven EU, Pacific Rim and The Americas regulatory strategy regarding all aspects of device commercialization and especially FDA Click here to register for this webinar activities. Background encompasses broad capabilities in quality systems, Who Will Benefit: validation, regulatory affairs, GxP compliance, auditing, interfacing with l All levels of management and departmental the regulatory agencies, managing representatives and those who desire a better enforcement actions and mitigating understanding or a "refresh" overview compliance exposure for companies, l Regulatory Affairs working with Notified Bodies, AR’s l Clinical Affairs and demonstrates credible l Quality and Compliance experience to maximize business l Marketing & Sales performance in the devices arena. l Distributors ...more l Engineering/Technical Services/Operations Related Products l Consultants ISO 13485 Gap Analysis Toolkit ISO 13485 Quality Manual Intro to ISO 13485 Presentation Materials ISO 13485 Internal Auditor Checklist more... Your Necessity is our Priority It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. 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"Combination Products: FDA's Proposed Rule for GMP Requirements and Introduction and Expectations for "Combo" Products"Please download to view full document