How to Prepare for, Manage, and Follow-up to an FDA Inspection - Webinar by GlobalCompliancePanel

MessageThis Webinar is over
Date Feb 11, 2014
Time 10:00am
Cost $245.00
Online
Overview:
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? 

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 performance is not good, it is not the show that may close, it is YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations! 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. 

Areas Covered in the Session:
  • How to prepare for an FDA inspection
  • Development and contents of an SOP for FDA inspection
  • Personnel training before inspection
  • How to behave during an inspection
  • What to show FDA during an inspection
  • Proper Post-inspection Followup
  • Limitations of scope of inspection 
  • Response to investigation findings 
  • FDA guidance documents used by their inspectors
Who Will Benefit:
  • Internal / External Auditors
  • Regulatory Management
  • Quality Assurance Professionals
  • Consultants
  • Sales/Marketing Management
  • Senior and mid-level Management
  • Quality System Auditors
Jeff Kasoff, RAC, CQM, is the Director of Quality at Medivators, a leading manufacturer of consumables and instrumentation in the endoscopy field. Among his responsibilities is oversight of the document control system. In his 20+ years of Quality and Regulatory management, Jeff has implemented and overseen document control systems at all sizes of company, from startup to $100 million in revenue. 

Contact Information:
NetZealous LLC,
DBA GlobalCompliancePanel 
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA          
USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com    
http://www.globalcompliancepanel.com

 


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