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DTSTAMP:20260522T163206Z
SUMMARY:FDA Inspection Essentials
DESCRIPTION:The inspection management plan should provide for, Respons
 e to the arrival of the investigators, Guidance of the inspectors’ a
 ctivities, Procedure for working with the investigators, and Documenta
 tion of the inspection. The management plan or SOP should spell out al
 l of the procedures that you will follow during an investigation. Pers
 onnel training is one key variable that should be looked at prior to a
 ny inspection. Educate personnel about the inspection process so they 
 can be prepared. Train individuals to interface with FDA investigators
 . Verify that training has been provided for the personnel on their cu
 rrent job functions, and that supporting records are on file. The goal
  is to minimize the opportunity for incorrect answers provided to the 
 inspectors, or providing too much information. Have a list of what to 
 do and what not to do when speaking to the inspectors as well.\n\nWhy 
 Should You Attend:\nYou need not dread an FDA inspection if you are ad
 equately prepared. FDA inspections have revealed some trends in recent
  years. The agency is taking a tougher stand on Quality Systems and us
 ing a risk-based approach. Inspectors usually review at least two (2) 
 systems in depth. QA is their number one concern in recent years. They
  may also look at another system, such as facilities and equipment, ma
 terials, production, packaging and labeling or laboratory controls.\nF
 DA does not expect your facility to be perfect. They expect all compan
 ies to have some issues. What they really want to see is how you addre
 ss the problems. The FDA tends to view companies that control these is
 sues to have a high standard of quality. This seminar will help you us
 e the FDA inspection as a learning tool, not as a negative or adversar
 ial experience.\nUpon completion of this session, you will learn the p
 roper way to set up for a Regulatory Inspection, ensuring the inspecti
 on flows smoothly throughout the duration, and the proper way to speak
  to inspectors while they are performing the audit.\nLearning Objectiv
 es:\nUpon completion of this session, attendees will:\n\nLearn Pre-pla
 nning and preparation activities\nKnow What to do when the investigato
 r arrives\nKnow What documents to have ready and on hand\nDevelop Assi
 gnments and responsibilities for the inspection\nBe Aware of Inspectio
 n Do's and Don'ts\n\nWho will Benefit:\n\nQuality Control Personnel & 
 Management\nManufacturing Personnel & Management\nSenior Management\nR
 egulatory Affairs Personnel & Management\nQuality Assurance Personnel 
 & Management\n\n\nFor more information visit https://medtechiq.ning.co
 m/events/fda-inspection-essentials
DTSTART;TZID=America/New_York:20210428T100000
DTEND;TZID=America/New_York:20210429T150000
CATEGORIES:seminae
LOCATION:online
WEBSITE:https://www.complianceonline.com/fda-inspection-essentials-sem
 inar-training-80662SEM-prdsm?channel=MedTech%20I.Q
URL:https://www.complianceonline.com/fda-inspection-essentials-seminar
 -training-80662SEM-prdsm?channel=MedTech%20I.Q
CONTACT:8887172436
ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer
 ral512
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/8704928464?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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