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UID:2140535:Event:67242
DTSTAMP:20260907T235824Z
SUMMARY:Webinar On FDA vs EU Inspections – Differences and How to Ge
 t Prepared
DESCRIPTION:Description :\nThis training is a comparative look at FDA 
 & EU regulations to help attendees understand the FDA and EU inspectio
 n process and how to prepare for both of them. Attendees will learn th
 e best practices to respond to Form 483 citations, Warning Letters and
  EU inspection findings.\nFDA and EU GCP regulations and standards app
 ly pharmaceuticals, biologics and medical devices. Failure to conform 
 to these requirements may result in concerns about quality and integri
 ty. Inspections are critical to the success of business on several lev
 els. Therefore, being appropriately prepared and management of the ins
 pection and audit process are critical activity. The consequences if a
  company does not pass an inspection are time consuming, delayed produ
 ct approvals, and could lead to civil or even criminal litigation by t
 he FDA and EU inspection agencies.\nThis webinar has been specifically
  designed to help attendees prepare for FDA and EU inspection. It will
  provide a background and understanding of the role played by the regu
 latory inspectors, and the administrative and enforcement powers. Atte
 ndees will be taken through the key stages of FDA and EU inspection pr
 ocesses and understands the various types of inspections that can be c
 arried out.\nAreas Covered in the Session :\nDifferences between FDA a
 nd EU Inspections including the FDA and EU joint inspection programmer
 \nHow to prepare for EMA and FDA audit\nHow to plan for an audit or in
 spection using checklists/ FDA/EMEA inspection guidelines\nTips for em
 ployees before the inspect\nTips on proper responses to prepare for au
 dit/inspection Interviews\nSetting up a Triage to ensure that required
  documents are available\nHow to interact with the inspectors—DO's a
 nd DON’Ts\nHow to reply to inspection reports, 483’s and EU inspec
 tion finding\nPost inspection actions – implementing appropriate CAP
 As in response to audit findings\nWho Will Benefit:\nQuality Assurance
  Managers\nQuality Auditors\nRegulatory Affairs Teams\nDocument Manage
 ment Teams\nProfessionals who want to know more about inspection guide
 lines\n\nFor more information visit https://medtechiq.ning.com/events/
 webinar-on-fda-vs-eu-inspections-differences-and-how-to-get
DTSTART;TZID=America/New_York:20151203T130000
DTEND;TZID=America/New_York:20151203T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=FDB1645
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=FDB1645
CONTACT:4169154458
ORGANIZER:Compliance Trainings
ATTACH;FMTTYPE="image/jpeg":
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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