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UID:2140535:Event:471860
DTSTAMP:20260409T225714Z
SUMMARY:Best Practices in Preparation for an FDA Computer System Audit
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. It will also
  consider areas where FDA will likely focus their effort, including on
  the higher-risk systems. It will cover areas that will help you to pl
 an for an on-site inspection.\nWhy Should You Attend:\nFDA requires th
 at all computer systems that handle data regulated by the Agency to be
  validated in accordance with their guidance on computerized systems. 
 This guidance was first issued in 1983, and the main points of focus r
 emain consistent today, despite the number of years that have passed a
 nd the technology changes that have taken place.\nThe FDA computer sys
 tem guidance was revisited for its application to the medical device i
 ndustry, as the first issuance addressed pharmaceuticals. In 1997, 21 
 CFR Part 11 was issued to address electronic records and signatures, a
 s many laboratories and other FDA-regulated organizations began seekin
 g ways to move into a paperless environment. This guidance has been mo
 dified over the years to make it more palatable to industry, and this 
 includes discretionary enforcement measures. The intent was to avoid c
 reating a huge regulatory compliance cost to industry that was initial
 ly preventing companies from embracing the technology.\n\nAreas Covere
 d in the Webinar:\nThis webinar will cover the following key areas:\n\
 nComputer System Validation (CSV) and the System Development Life Cycl
 e (SDLC) Methodology\n“GxP” – Good Manufacturing, Laboratory and
  Clinical Practices\n21 CFR Part 11, Electronic Records/Electronic Sig
 natures (ER/ES)\nData Archival to ensure security, integrity and compl
 iance\nValidation Strategy that will take into account the system risk
  assessment and system categorization (GAMP V) processes\nRecent FDA f
 indings for companies in regulated industries\nThe resources, document
 ation and room preparation necessary to adequately prepare for inspect
 ion\nQ&A\n\nWho Will Benefit:\nThis webinar is intended for those invo
 lved in planning, execution and support of computer system validation 
 activities, working in the FDA-regulated industries, including pharmac
 eutical, medical device, biologics, tobacco and tobacco-related produc
 ts (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.). Functions t
 hat are applicable include research and development, manufacturing, Qu
 ality Control, distribution, clinical testing and management, sample l
 abeling, adverse events management and post-marketing surveillance.\nE
 xamples of who will benefit from this webinar include:\n\nInformation 
 Technology Analysts\nInformation Technology Developers and Testers\nQC
 /QA Managers and Analysts\nAnalytical Chemists\nCompliance and Audit M
 anagers\nLaboratory Managers\nAutomation Analysts\nManufacturing Speci
 alists and Managers\nSupply Chain Specialists and Managers\nRegulatory
  Affairs Specialists\nRegulatory Submissions Specialists\nRisk Managem
 ent Professionals\n\n\nFor more information visit https://medtechiq.ni
 ng.com/events/best-practices-in-preparation-for-an-fda-computer-system
 -audit
DTSTART;TZID=America/New_York:20220310T100000
DTEND;TZID=America/New_York:20220310T130000
CATEGORIES:webinar
LOCATION:online
WEBSITE:https://www.complianceonline.com/best-practices-in-fda-compute
 r-system-audit-preparation-webinar-training-706354-prdw?channel=MedTec
 h%20I.Q
URL:https://www.complianceonline.com/best-practices-in-fda-computer-sy
 stem-audit-preparation-webinar-training-706354-prdw?channel=MedTech%20
 I.Q
CONTACT:8887172436
ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer
 ral512
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ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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