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UID:2140535:Event:68725
DTSTAMP:20260413T082143Z
SUMMARY:Webinar on Best Practices in Preparation for an FDA Computer S
 ystem Audit
DESCRIPTION:Description :\nThe Webinar will discuss the importance of 
 preparing for and participating in a computer system validation audit 
 by regulatory agencies. Regulatory agencies fully expect companies to 
 comply with the computer system validation guidelines that were establ
 ished in 1983 and have evolved over the last thirty years to align wit
 h changes in technology and best practices developed by industry, incl
 uding the inclusion of risk assessment as a critical component of vali
 dation.\nValidation of computer systems in the regulatory environment 
 must be a continuous rather than a discrete process. When auditing, re
 gulatory agencies will expect you to have adequately planned and execu
 ted your computer system validation effort, and continue to maintain y
 our system in a validated state.\nThere are specific best practices to
  be followed that will ensure you are fully prepared to defend your pr
 ogram and prove that you have thoroughly validated your computer syste
 ms that are subject to regulatory scrutiny. Being prepared will ensure
  a much easier interaction with the regulatory agency and will minimiz
 e the time and cost of the audit. A company’s readiness may also min
 imize the risk of findings and citations by showing the auditors that 
 you have done due diligence and are able to respond adequately to all 
 questions and requests for information in a timely manner.\nAreas Cove
 red in the Session :\nDescribe the key components and importance of re
 gulatory audits of validated computer systems\nDiscuss best practices 
 for preparing for a computer system validation audit by a regulatory a
 gency\nProvide examples of the documentation you can prepare to minimi
 ze risk and ensure your audit is successful\nDiscuss best practices fo
 r participating in a computer system validation audit by a regulatory 
 agency\nProvide examples of what you can do during the audit to minimi
 ze risk, time and overall cost\nDiscuss best practices for developing 
 a positive relationship with regulatory agency auditors and building a
  reputation for preparedness, thoroughness and integrity\nInteractive 
 Q&A Session\nWho Will Benefit:\nThis webinar is intended for those wor
 king in FDA-regulated industries, including pharmaceutical, medical de
 vice, biological, animal health and tobacco. Functions that are applic
 able include research and development, manufacturing, Quality Control,
  distribution, clinical testing and management, adverse events managem
 ent and post-marketing surveillance.\nYou should attend this webinar i
 f you are responsible for planning, executing or managing the implemen
 tation of any system governed by FDA regulations, or if you are mainta
 ining or supporting such a system. Examples of who will benefit from t
 his webinar include:\nCompliance and Audit Managers\nInformation Techn
 ology Analysts\nInformation Technology Developers and Testers\nQC/QA M
 anagers and Analysts\nClinical Data Managers and Scientists\nAnalytica
 l Chemists\nLaboratory Managers\nAutomation Analysts\nComputer System 
 Validation Specialists\nGMP Training Specialists\nBusiness Stakeholder
 s/Subject Matter Experts\nBusiness System/Application Testers\nThis we
 binar will also benefit any consultants working in the tobacco or life
  science industries who are involved in computer system implementation
 , validation and compliance.\n\nFor more information visit https://med
 techiq.ning.com/events/webinar-on-best-practices-in-preparation-for-an
 -fda-computer
DTSTART;TZID=America/New_York:20160314T130000
DTEND;TZID=America/New_York:20160314T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=FDB1824
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=FDB1824
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
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