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DTSTART:19700308T020000
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UID:2140535:Event:468481
DTSTAMP:20260602T042458Z
SUMMARY:Data Integrity: FDA/EMA Requirements and Implementation
DESCRIPTION:The use of computer systems in virtually every aspect of d
 ata acquisition, storage, and analysis can help preserve data integrit
 y and reduce or eliminate many errors, but the same technology can als
 o create unique problems that must be prevented and managed.\nIn this 
 two day workshop conference you will learn the meaning of \"data integ
 rity\"; be exposed to some of the history that influences current regu
 latory requirements and expectations; see a comparison of the current 
 guidance from leading regulatory agencies including the FDA, EMA, TGA 
 and key industry associations such as the Parenteral Drug Association;
  see a recap of the enforcement options available to the FDA, includin
 g imposition of the Application Integrity Policy (also known as the \"
 Fraud Policy\"); discuss and learn from selected current real-life cas
 e histories; and hear advice for how to prevent, detect and react to d
 ata integrity problems so as to minimize business and regulatory risk.
 \n\nLearning Objectives:\nUpon completing this course participants sho
 uld:\n\nUnderstand the meaning of the term “data integrity” and th
 e importance of the acronym “A.L.C.O.A.” to regulatory agencies\nU
 nderstand the difference between innocent lapses and deliberate wrongf
 ul conduct\nBe aware of some of the key historical events that form th
 e basis for regulators’ concerns about data integrity\nUnderstand so
 me of the common motivations for deliberate wrongful conduct that resu
 lts in data falsification\nUnderstand the impact of the use of compute
 r systems on the maintenance of data integrity, and what types of syst
 em controls are mandated by various agencies around the world\n\nWho w
 ill Benefit:\nThis course is designed for people who generate, review 
 and archive data in support of marketing authorization applications to
  health regulatory agencies such as the FDA, EMA and TGA, and those wh
 o generate, review and archive GMP, GCP and GLP data in manufacturing,
  clinical trials and pre-clinical testing laboratories. The following 
 personnel will benefit from the course:\n\nSenior Quality and Regulato
 ry Affairs managers\nClinical and Manufacturing Quality professionals\
 nRegulatory Affairs professionals\nCompliance professionals\nIn House 
 Legal Counsel\nProduction supervisors\nManufacturing personnel\nProduc
 tion personnel\nLaboratory Managers\n\n\nFor more information visit ht
 tps://medtechiq.ning.com/events/data-integrity-fda-ema-requirements-an
 d-implementation
DTSTART;TZID=America/New_York:20210714T110000
DTEND;TZID=America/New_York:20210715T170000
CATEGORIES:seminae
LOCATION:online
WEBSITE:https://www.complianceonline.com/data-integrity-in-the-pharmac
 eutical-industry-seminar-training-80433SEM-prdsm?channel=MedTech%20I.Q
URL:https://www.complianceonline.com/data-integrity-in-the-pharmaceuti
 cal-industry-seminar-training-80433SEM-prdsm?channel=MedTech%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/9012533063?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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