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:468195 DTSTAMP:20260410T030900Z SUMMARY:Global Regulations for Equipment Qualification and Validation of Processes in the Pharma Manufacturing DESCRIPTION:The various regulatory agencies have expectations that pha rmaceutical manufacturers will demonstrate control over their manufact uring equipment. The FDA's findings of deficiencies concerning equipme nt validation indicate the agencies expect definitive evidence that th e equipment qualification and validation schedules of a facility will satisfactorily control their manufacturing processes. Examples of FDA form 483 findings for equipment qualification and validation indicate deficiencies in many of these studies.\nThe cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for equipment qualification and validation in your ma nufacturing facility?\nIn this two day workshop conference you will le arn the different global agencies expectations of equipment qualificat ion along with the development of a sound process validation program i n order to develop and implement bulletproof solutions that are accept ed, effective, and efficient. Through case study analysis we will exam ine best practices to provide thoughts and ideas to develop or improve the performance of your current system. Additionally, case studies wi ll explore how your management practices of your equipment qualificati on/ validation and process validation programs can help or hurt your l egal liability and the legal issues that arise from nonconformance wit h regulators and Auditors.\nLearning Objectives:\nUpon completing this course participants should:\n\nUnderstand what the global expectation s are for equipment qualification and validation.\nUnderstand the docu ments required for equipment qualification and process validation and how to manage documents appropriately.\nUnderstand and know how to wri te and maintain a Validation Master Plan.\nWrite and execute sound pro tocols for equipment qualification (IQ, OQ, PQ) and process validation .\nQualify already existing systems and requalification\nBe able to co llect data, conduct tests, and obtain all necessary documents.\nUnders tand the different types of validation.\nUnderstand Performance Valida tion.\nKnow the guidelines on validating analytical methods and proces ses.\n\nWho will Benefit:\nThis course is designed for people tasked w ith developing, maintaining and/or improving equipment qualification p rograms for manufacturing facilities. This includes individuals that h ave Quality Management Systems responsibilities for making general imp rovements in their organization's performance specifically related to equipment and processes. Following personnel will benefit from the cou rse:\n\nSenior quality managers\nQuality professionals\nRegulatory pro fessionals\nCompliance professionals\nProduction supervisors\nValidati on engineers\nManufacturing engineers\nProduction engineers\nDesign en gineers\nProcess owners\nQuality engineers\nQuality auditors\n\n\nFor more information visit https://medtechiq.ning.com/events/global-regula tions-for-equipment-qualification-and-validation-of DTSTART;TZID=America/New_York:20210315T180000 DTEND;TZID=America/New_York:20210315T190000 CATEGORIES:seminae LOCATION:online WEBSITE:https://www.complianceonline.com/equipment-qualification-dq-iq -oq-pq-process-validation-vmp-seminar-training-80295SEM-prdsm?channel= MedTech%20I.Q URL:https://www.complianceonline.com/equipment-qualification-dq-iq-oq- pq-process-validation-vmp-seminar-training-80295SEM-prdsm?channel=MedT ech%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/8669366452?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc eOnline:https://medtechiq.ning.com/profile/Referral512 END:VEVENT END:VCALENDAR