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PRODID:-//github.com/rianjs/ical.net//NONSGML ical.net 4.0//EN
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DESCRIPTION:This webinar will help attendees understand the fundamental st
 eps of a deviation investigation with focus on using facts and objective 
 evidence to arrive at root cause and CAPA. Learn how to identify and avoi
 d potential pitfalls during deviation investigations.\n\nWhy Should You A
 ttend:\n\nOne of the most common FDA 483 and Warning Letter citations con
 tinues to be inadequate investigations. The FDA continues to find fault w
 ith investigations and the stated conclusions. The FDA clearly expects th
 at deviation investigations determine what happened\, why it happened\, a
 nd what was done to prevent it from happening again. Investigations also 
 receive detailed scrutiny during FDA inspections. The FDA uses the invest
 igation reports and investigation trends to identify potential quality pr
 oblems in all areas of the company. Investigations are one of the key met
 rics that the FDA uses to assess the effectiveness of an organization’s Q
 uality Systems. Ultimately\, inadequate investigations can lead to 483 ci
 tations\, Warning Letters\, release of sub-standard product\, or product 
 recall. Furthermore\, costly and time-consuming system remediation may be
  required.\n\nMost companies develop deviation investigation systems and 
 SOPs to meet regulatory requirements and expectations. However\, having g
 ood systems and procedures is not enough. It is the content and conclusio
 ns of the investigations themselves that truly count. Arriving at correct
  content and conclusions relies on good investigative technique\, includi
 ng interviews\, fact/evidence gathering\, and proper determination of roo
 t cause and CAPA. Therefore\, it is important that investigators conduct 
 each and every investigation in the same manner\, and to the same standar
 ds with the emphasis on maintaining an effective quality system to assure
  product quality.\n\nThis webinar will help attendees understand the fund
 amental investigation steps and skill sets. Key focus will be placed on i
 dentification and initial reporting of deviations\, product containment c
 onsiderations\, fact/evidence gathering\, and arriving at the correct roo
 t cause and CAPA. The importance of investigation planning\, critical thi
 nking skills and avoidance of investigation bias will also be discussed.\
 n\n&nbsp\;\nAreas Covered in the Webinar:\n\n\nOverview of Regulatory Req
 uirements for Investigations\nWhat is a Deviation?\nTypes of Deviations/I
 dentification of Deviations\nDeviation Investigation Process Model\nImmed
 iate Containment/Immediate Impact\nConducting the Investigation/Investiga
 tion Principles\nInterviews\nSource Documents/Evidence\nDetermining Root 
 Cause and CAPA\nKey Elements of the Investigation Report\n\n&nbsp\;\nWho 
 Will Benefit:\n\n\nDeviation investigators\nReviewers and approvers of de
 viation investigations (e.g. Dept. Heads\, Quality Assurance)\nQA staff a
 nd management\nRegulatory Affairs staff and management\nQC staff and mana
 gement\nCompliance auditors\n
DTEND:20250109T113000
DTSTAMP:20260512T232952Z
DTSTART:20250109T100000
LOCATION:\,
SEQUENCE:0
SUMMARY:This webinar will help attendees understand the fundamental steps 
 of a deviation investigation with focus on using facts and objective evid
 ence to...
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END:VCALENDAR