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DTSTART:19700308T020000
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UID:2140535:Event:431289
DTSTAMP:20260516T065355Z
SUMMARY:Data Integrity: FDA/EU Requirements and Implementation
DESCRIPTION:Data integrity has been a focus for pharmaceutical regulat
 ory inspections for a number of years and look set to remain of concer
 n to regulators and manufacturers for many years to come. Many inspect
 ion reports from regulatory agencies around the world cite data integr
 ity as a cause of observations and enforcement action, and actions tak
 en by regulators to restrict the commercial activities of manufacturer
 s on the grounds of data integrity violations have obvious serious con
 sequences for the company concerned.\nThis 2-day online course explain
 s the background to the data integrity regulations and sets out the ex
 pectations of pharmaceutical regulators. All the current data integrit
 y guidances emphasize a risk-based approach to compliance, and the cou
 rse explains how to evaluate and control data integrity risks. A key r
 esource in relation to electronic records is GAMP 5, which deals with 
 controlling risk and managing computerized systems over their life cyc
 le. The practices recommended by GAMP 5 will be dealt with in detail, 
 and practical advice on the appropriate use of Excel spreadsheets give
 n. Data integrity should not be thought of as an exclusively analytica
 l problem, and examples of data integrity violations in production wil
 l highlight the risks during manufacturing.\nLearning Objectives:\nAtt
 endees will:\n\nUnderstand what data integrity is and why it is so imp
 ortant for patient safety\nRecognise that there are many causes of dat
 a integrity breaches\nKnow the current regulatory expectations\nApprec
 iate the difference between static and dynamic records, and be able to
  apply acceptable strategies for the retention of both types of record
 \nBe able to categorise and validate GxP computerised systems accordin
 g to GAMP 5\nUnderstand the importance of training and quality culture
  in avoiding regulatory enforcement action\nLearn how to respond to da
 ta integrity observations in inspection reports\nLearn how to prevent,
  detect and remedy data integrity problems\n\nWho will Benefit:\n\nQA 
 managers and personnel\nLaboratory managers and supervisors\nProductio
 n managers and supervisors\nAnalysts\nIT/IS managers and system admini
 strators\nSoftware developers\nRegulatory affairs\nTraining department
 s\nDocumentation departments\nConsultants\nAuditors\n\n\nFor more info
 rmation visit https://medtechiq.ning.com/events/data-integrity-fda-eu-
 requirements-and-implementation
DTSTART;TZID=America/New_York:20210121T100000
DTEND;TZID=America/New_York:20210122T170000
CATEGORIES:seminae
LOCATION:online
WEBSITE:https://www.complianceonline.com/data-integrity-fda-eu-require
 ments-and-implementation-seminar-training-80408SEM-prdsm?channel=MedTe
 ch%20I.Q
URL:https://www.complianceonline.com/data-integrity-fda-eu-requirement
 s-and-implementation-seminar-training-80408SEM-prdsm?channel=MedTech%2
 0I.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/8270269870?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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