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.
Toll Free Number: 800-447-9407 RAPS Approved Webinar on FDA Inspections - Do's and Don'ts Date: Tuesday, November 27, 2012 Time: 10:00 AM PST | 01:00 PM EST Course "FDA Inspections - Do's and Don'ts" has been Duration: 60 Minutes pre-approved by RAPS as eligible for up to 1.00 Instructor: Jeff Kasoff credits towards a participant's RAC recertification upon full completion. Location: Online Jeff Kasoff Director of Regulatory Register Now Affairs, Life-Tech, Inc Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices, where he oversees the operation of the quality system. In this position, ...more 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. l Does the FDA call in advance or just show up at my door? l Where do I let the inspector go? l Do I give them a tour? l What should I let them see? l Who should I let them talk to? Are they ever going to leave? 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 Who Will Benefit: l Internal / External Suggest a Topic Auditors l Regulatory Management More Webinars l Quality Assurance Professionals l Consultants l Sales/Marketing Management Click here to l Senior and mid-level register for this Management webinar 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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