Overview: This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.
RAPS Approved Webinar on FDA Inspections - Do's and Don'ts Date & Time: Course "FDA Inspections - Do's and Don'ts" has been pre- approved by RAPS as eligible for up to 1.00 credits towards a Register Now participant's RAC recertification upon full completion. Instructor Profile: Tuesday, September 25, 2012 10:00 AM PDT | 01:00 PM EDT Duration: 60 Minutes Instructor: Jeff Kasoff Jeff Kasoff Director of Regulatory Location: Online Price : $245.00 (for one participant) Affairs, Life-Tech, Inc Jeff Kasoff, RAC, is the Director of Overview: Quality at Byrne Medical, a leading This session will discuss how to prepare for the inspection, what to manufacturer of endoscopy and d o during the inspection and the close-out interview, and how to colonoscopy devices, where he respond to the inspection. Also contained in this session will be the oversees the operation of the quality limits of FDA's scope during an inspection, including what documents system. In this position, Jeff is responsible for oversight of the you are not required to show them, and the permissibility of document control system, including photographs and affidavits. maintenance of regulatory documentation. Prior to this, Jeff l Does the FDA call in advance or just show up at my door? spent 13 years at Life-Tech, Inc. as l Where do I let the inspector go? the Director of Regulatory Affairs, l Do I give them a tour? where he was responsible for l What should I let them see? compliance of the corporate quality system. Jeff received his regulatory l Who should I let them talk to? Are they ever going to leave? affairs certification in 1996. ...more The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your Suggest a Topic More Webinars performance is not good, it is not the show that may close, it is YOUR Your Necessity is our Priority COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations! Areas Covered in the Session: l How to prepare for an FDA inspection l Development and contents of an SOP for FDA inspection l Personnel training before inspection l How to behave during an inspection l What to show FDA during an inspection l Proper Post-inspection Follow-up l Limitations of scope of inspection l Response to investigation findings l FDA guidance documents used by their inspectors Click here to register for this webinar Who Will Benefit: l Internal / External Auditors l Regulatory Management l Quality Assurance Professionals l Consultants l Sales/Marketing Management l Senior and mid-level Management l Quality System Auditors 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
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