BEGIN:VCALENDAR
PRODID:NingEventWidget-v1
VERSION:2.0
METHOD:PUBLISH
BEGIN:VTIMEZONE
TZID:America/New_York
X-LIC-LOCATION:America/New_York
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:19700308T020000
RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:19701101T020000
RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
UID:2140535:Event:470980
DTSTAMP:20260523T005005Z
SUMMARY:FDA Compliance and Enforcement Trends focused on Data Integrit
 y
DESCRIPTION:FDA requires that all computer systems used to produce, ma
 nage and report on “GxP” (GMP, GLC, GCP) related products be valid
 ated and maintained in accordance with specific rules. This webinar wi
 ll help you understand the FDA’s current thinking on computer system
 s that are validated and subject to inspection and audit.\nWhy Should 
 You Attend:\nEffective and compliant computer system validation is cri
 tical to any FDA-regulated organization. FDA has set forth very specif
 ic requirements for meeting compliance, and a very prescriptive set of
  enforcement actions to protect patient and/or consumer safety. This c
 ourse will enable you to best anticipate and prepare for FDA scrutiny,
  understand your role during inspections and audits, and gain insight 
 to the level of enforcement associated with various findings, consent 
 decrees and warning letters. Examples from industry will be used as ca
 se studies to illustrate these.\nIt is vital for regulated companies t
 o maintain a pulse on the regulatory environment in order to fortify s
 ystem validation efforts, as necessary, to meet FDA expectations. It i
 s the best practice to have a robust computer system validation, conti
 nue executing against it consistently, and documenting it thoroughly. 
 By maintaining a strong and consistent computer system validation prog
 ram, companies can further build trust with FDA and the consumers who 
 rely on such oversight for protection.\nAreas Covered in the Webinar:\
 n\nLearn about Computer System Validation (CSV) and the System Devel
 opment Life Cycle (SDLC) Methodology\nLearn about the importance of do
 ing a risk assessment of all FDA-regulated systems\nLearn about the im
 portance of categorizing your FDA-regulated software according to GAMP
  5 guidelines\nUnderstand “GxP” Systems\nUnderstand 21 CFR Part 1
 1, Electronic Records/Electronic Signatures (ER/ES)\nLearn how Data Ar
 chival plays a key role in ensuring security, integrity and compliance
 \nLearn how to develop a solid Validation Strategy that will take into
  account the system risk assessment and system categorization (GAMP V)
  processes\nLearn about recent FDA findings for companies in regulated
  industries, specifically related to computer systems, validation, 21 
 CFR Part 11 and Data Integrity\nUnderstand the latest guidance from F
 DA on data integrity\n\nWho Will Benefit:\nThis webinar is intended fo
 r those involved in planning, execution and support of computer system
  validation activities, working in the FDA-regulated industries, inclu
 ding pharmaceutical, medical device, biologics, tobacco and tobacco-re
 lated products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.).
  Functions that are applicable include research and development, manuf
 acturing, Quality Control, distribution, clinical testing and manageme
 nt, sample labeling, adverse events management and post-marketing surv
 eillance.\nExamples of who will benefit from this webinar include:\n\n
 Information Technology Analysts\nInformation Technology Developers and
  Testers\nQC/QA Managers and Analysts\nAnalytical Chemists\n\n\nFor mo
 re information visit https://medtechiq.ning.com/events/fda-compliance-
 and-enforcement-trends-focused-on-data-integrity
DTSTART;TZID=America/New_York:20220128T180000
DTEND;TZID=America/New_York:20220128T190000
CATEGORIES:webinar
LOCATION:online
WEBSITE:https://www.complianceonline.com/fda-compliance-trends-and-enf
 orcement-webinar-training-706353-prdw?channel=MedTech%20I.Q
URL:https://www.complianceonline.com/fda-compliance-trends-and-enforce
 ment-webinar-training-706353-prdw?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/10052915891?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
END:VEVENT
END:VCALENDAR