BEGIN:VCALENDAR PRODID:-//github.com/rianjs/ical.net//NONSGML ical.net 4.0//EN VERSION:2.0 BEGIN:VEVENT DESCRIPTION:Use coupon COMPLIANCE15 to get 15% discount on this virtual se minar\n\nDevelop / review a company's Master Validation Plan for major cG MP deficiencies. Address the U.S. FDA's newer and tougher regulatory stan ce. One major failing is lack of sufficient or targeted risk-based V&\ ;V planning:\n\n\nStart with a Master Validation Plan\;\nEvaluate its ele ments against ISO 14971 and ICH Q9 for hazard analysis and product risk m anagement\;\nThe Individual V&\;V Plan\;\nV&\;V Project Management\ ;\n“Risk-based” per ISO 14971\, ICH Q9\, and/or GAMP/JETT\;\nTwo key inpu t analysis tools\;\nChange control and “drawing a line in the sand”\;\nDe velop meaningful V&\;V Files and Protocols for:\n\nProducts\;\nProcess \;\nProduction Equipment\;\nMonitoring and Test Equipment\;\nSoftware\;\n Quality Management System – 21 CFR 11\, Electronic Records / Signatures\; \n\n\nThe roles of different V&\;V protocols\;\nHow to employ equipmen t / process DQs\, IQs\, OQs\, and PQs\, or their equivalents\,\nV&\;V against a background of limited company resources\;\nThe FDA's 11-element software matrix simplifies "as-product"\, in-product"\, process and equi pment\, et al\, software VT&\;V\;\nAssure key U.S.FDA and comparable E U MDD / ISO requirements are not overlooked\;\nThe QMS and 21 CFR Part 11 \, “Electronic Records / Signatures” V&\;V\;\nHands-on examples and ac tivities show real-world implementation of useful principles\, tools and templates\;\n\nLearning Objectives:\n\nUnderstand Verification and Valida tion\, differences and how they work together\nDevelop a “Working Definit ion” of V&\;V\, Qualification\, and related terms\nDiscuss recent regu latory expectations\nHow to document a “risk-based” rationale\, and use i t in a resource-constrained environment\nDetermine key “milestones” and “ tasks” in a project\; device sample provided\nLocate and document key sub ject “inputs”\nCompile “generic” Master and Individual Validation Plans\n Lean the key element of a Product V&\;V File / Protocol\nHow to develo p Process and/or Production / Test Equipment V&\;V Files / Protocols\n Basic Test Case / Script construction\nSample sizes and their justificati on\nLean the key 11 elements of Software V&\;V expected by the FDA and how to document\nSee how to compile QMS Electronic Records and Electroni c Signatures V&\;Vs per 21 CFR 11 and related CGMPs\n\nWho will Benefi t:\nThis seminar will provide valuable assistance to all regulated compan ies that need to review and modify their Master Validation Planning and P lan(s). While this information is focused on Medical Devices\, its princi ples apply to personnel / companies in the Pharmaceutical\, Diagnostic\, and Biologics fields. The employees who will benefit include:\n\n\nSenior and middle management and staff\nRegulatory Affairs\nQA/QC\nIT/IS\nR& \;D\nProduction Management\nManufacturing Engineers\nProcess Engineers\nS oftware Engineers\nProject Managers\nHardware and software vendors\, sale s and marketing\n DTEND:20260318T150000 DTSTAMP:20260419T033103Z DTSTART:20260317T090000 LOCATION:\, SEQUENCE:0 SUMMARY:Use coupon COMPLIANCE15 to get 15% discount on this virtual semina r\nDevelop / review a company's Master Validation Plan for major cGMP def iciencie... UID:89fa5e1c-0552-4c4a-8aae-98904081f0b4 END:VEVENT END:VCALENDAR