Overview: Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling. This Webinar will explain the regulatory process and in understandable terms.
Live Webinar on Regulatory Complaint Handling, MDR's & Recalls Course "Regulatory Complaint Handling, MDR's & Recalls" has been pre-approved by RAPS as eligible for up to 1.00 credits towards a participant's RAC recertification upon full completion. Register Now Date & Time: Instructor Profile: Wednesday, August 01, 2012 10:00 AM PDT | 01:00 PM EDT Duration: 60 Minutes Instructor: John Chapman John Chapman Regulatory Affairs Location: Online Price : $245.00 (for one participant) Professional, John Chapman, BS, MBA, RAC has Overview: over 30 years medical device Medical device firms need to be aware of the benefits of compliance regulatory experience and over 10 a s well as the dangers of inadequate complaint handling. This years experience with the European Webinar will explain the regulatory process and in understandable Union's medical device directive, terms. 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has Many medical device firms face regulatory issues as a result of been performed regulatory due inadequate complaint handling. FDA has explicit complaint handling diligence on over a dozen requirements and poor complaint & reporting procedures often result acquisitions in the past 12 years, in costly recalls and warning letters. FDA warning letters and recalls exposing him to numerous quality are posted on FDA's website and published in trade magazines, systems, including consent decrees newspapers available to firm's competitors, and has even driven the as well as many notified bodies. He firm's stocks down. This presentation will review the regulations and earned his regulatory affairs certification (RAC) in 1998 and was a point out some of the pitfalls in complaint handling and reporting. contributing author to 2004 Fundamentals of EU Regulatory Areas Covered in the Session: Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the l FDA's Complaint Definition 820.3 (b). annual RAPS conference. ...more l Complaint Documentation. l Part 803 - Medical Device Reporting. l Part 806 - Reports of Corrections & Removals. Suggest a Topic More Webinars l Warning letters and other FDA Remedies. l Complaint Handling Pitfalls. Your Necessity is our Priority Click here to register for this webinar Who Will Benefit: Some employees who wish to gain a better understanding include: l Quality & Regulatory Professionals l Manufacturing & Design Engineers l Marketing Product Managers l Corporate & Operations Executives 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. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe
Pages to are hidden for
"Regulatory Complaint Handling, MDR's & Recalls - Webinar By GlobalCompliancePanel"Please download to view full document