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UID:2140535:Event:471082
DTSTAMP:20260523T165518Z
SUMMARY:21 CFR Part 11 and QMS Software Risk-Based Implementation
DESCRIPTION:CGMP-compliant companies must develop / implement formal s
 oftware controls and usage, starting with proper verification and vali
 dation methods. This is an important consideration for a company’s Q
 uality Management System (QMS) and must consider applicable elements o
 f electronic records / signatures / Part 11. The US FDA recently added
  data integrity and cybersecurity to these requirements. These activit
 ies must be properly documented.\nWhy Should You Attend:\nSoftware / f
 irmware design, development, testing / verification and validation, im
 plementation and usage, is difficult to structure, manage, document an
 d control, especially in the QMS with Pt. 11. For many companies the s
 ubject can be intimidating. Software and firmware use in regulated ind
 ustry is under increased scrutiny by the U.S. FDA, and is a growing co
 ncern by all regulatory agencies worldwide. Quality Management System 
 are heavily software / firmware driven in today's manufacturing, with 
 the added concerns of 21 CFR Part 11 (Annex 11 in the EU), data inte
 grity and cybersecurity.\nA comprehensive, corporate wide plan, accomp
 anied by proper implementation and use of a defined life-cycle, and do
 cumentation, is a necessity. Growing \"cloud\" issues add urgency to u
 pgrade control. Regulatory requirements also demand a product risk-bas
 ed approach. And there’s IEC 62304 and GAMP(reg.) 5. What are the be
 st practices? How can tougher regulatory (FDA and EU) expectations be 
 met? What implementation and control is necessary to minimize software
  failures or breaches? How to use the FDA's own \"model\" to document 
 SW V&V. This systematic approach also adds predictability (time and bu
 dget) to software development, implementation, use, and decommissionin
 g.\n\nAreas Covered in the Webinar:\n\nU.S. FDA's expectations / requi
 rements\nRecent Data Integrity and Cybersecurity regulatory requiremen
 ts\nRoles of Verification and Validation; Legal requirements; Recommen
 ded “best practices”\nThe development of a 21-year long, field-tes
 ted FDA \"Model\"\nBasic development, implementation, use, and decommi
 ssioning expectations\n21 CFR Part 11 (electronic records / signatures
 ) requirements, and its implementation\nExpected Regulatory Deliverabl
 es\nApplicable standards and industry-recommended Guidelines\n\n\nWho 
 Will Benefit:\n\nSenior and middle management\nQA\nRA\nR&D\nEngineerin
 g\nSoftware engineering\nProgrammers\nSales and Marketing\n\n\nFor mor
 e information visit https://medtechiq.ning.com/events/21-cfr-part-11-a
 nd-qms-software-risk-based-implementation
DTSTART;TZID=America/New_York:20220209T100000
DTEND;TZID=America/New_York:20220209T130000
CATEGORIES:webinar
LOCATION:online
WEBSITE:https://www.complianceonline.com/21-cfr-part-11-qms-software-r
 isk-based-implementation-webinar-training-706363-prdw?channel=MedTech%
 20I.Q
URL:https://www.complianceonline.com/21-cfr-part-11-qms-software-risk-
 based-implementation-webinar-training-706363-prdw?channel=MedTech%20I.
 Q
CONTACT:8887172436
ORGANIZER:Complianceonline
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/10043923253?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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