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UID:2140535:Event:66954
DTSTAMP:20260503T051740Z
SUMMARY:Webinar On How to Prepare Yourself for FDA's on-going Part 11 
 Inspection Program
DESCRIPTION:Description :\nFDA continues to enforce Part 11 through it
 s new Part 11 inspection and enforcement program. Just in the last 3 y
 ears, FDA issued more than 30 warning letters with Part 11 violations.
  Citations are related to inadequate integrity, security and availabil
 ity of electronic records but also related to validation of software a
 nd computer systems. There are many questions about the program, e.g.,
  what inspectors are looking at what are major findings. The seminar w
 ill have the answers. In addition, using industry proven case studies 
 on how to avoid 483 inspectional observations and warning letters atte
 ndees will learn how to prepare their organization for trouble-free Pa
 rt 11 related inspections.\nFor easy implementation, attendees will re
 ceive three SOPs\nChecklist: Part 11 compliance\nCase Studies: How to 
 avoid Part 11 related 483's and Warning Letters\nSOP:  Electronic Aud
 it trail: Specifications, Implementation, Validation\nAreas Covered in
  the Session :\nFDA's current inspection and enforcement practices\nFD
 A's new interpretation: learning from FDA  inspection reports\nStrate
 gy for cost-effective implementation of  Part 11: A six step plan\nRe
 commended changes to existing Part 11 programs to reduce costs\nJustif
 ication and documentation for the FDA and your management\nGoing throu
 gh case studies from laboratories, offices and manufacturing with grap
 hical workflow of records, step-by-step description, recommendations f
 or individual Part 11 requirements with justifications and documentati
 on for the FDA and your management.\nCase studies how to avoid or resp
 ond to Part 11 related observations with corrective actions to fix cur
 rent issues and preventive actions to prevent reoccurrence of the same
  or similar issues.\nHow to prepare your company for Part 11 Inspectio
 ns\nWho Will Benefit:\nA must attend webinar for professionals in Smal
 l, midsize and large Pharmaceutical companies, API manufacturers, Cont
 ract laboratories, Clinical testing laboratories, CROs, Medical device
  industry. The professionals who will benefit include all:\nQC manager
 s\nQA managers and personnel\nIT administrators\nAnalysts\nRegulatory 
 affairs\nTraining departments\nDocumentation department\nConsultants\n
 \nFor more information visit https://medtechiq.ning.com/events/webinar
 -on-how-to-prepare-yourself-for-fda-s-on-going-part-11
DTSTART;TZID=America/New_York:20151013T130000
DTEND;TZID=America/New_York:20151013T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=FDB1459
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=FDB1459
CONTACT:4169154458
ORGANIZER;CN=compliancetrainings:https://medtechiq.ning.com/profile/co
 mpliancetrainings
ATTACH;FMTTYPE="image/jpeg":
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
END:VEVENT
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