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DTSTAMP:20260519T222258Z
SUMMARY:Implementation and Management of GMP Data Integrity
DESCRIPTION:Overview:Data integrity is the assurance that data records
  are accurate, complete, intact and maintained within their original c
 ontext, including their relationship to other data records. This defin
 ition applies to data recorded in electronic and paper formats or a hy
 brid of both.\nTo assure the quality of raw materials, in process mate
 rials and finished goods,laboratory data integrity is assuming greater
  importance in current Good Manufacturing Practices (CGMP) for US Food
  and Drug Administration (FDA)-regulated industry. Data integrity and 
 security infractions are not only 21 Code of Federal Regulations (CFR)
  Part 11 issues but also severe CGMP violations.Why you should Attend:
  In recent years, FDA has increasingly observed CGMP violations invol
 ving data integrity during CGMP inspections. This is troubling because
  ensuring data integrity is an important component of industry's respo
 nsibility to ensure the safety, efficacy, and quality of drugs, biolog
 ics and medical devices.These data integrity-related CGMP violations h
 ave led to numerous regulatory actions, including warning letters, imp
 ort alerts, and consent decrees. Attendees will obtain an understandin
 g of the Regulatory expectations for Data Integrity.The information pr
 ovided at the webinar will enable the attendees to review practices at
  their own site and identify gaps in their own practices.Areas Covered
  in the Session:\n\nExamples of data integrity pitfalls\nPart 11 compl
 iance data integrity issues\nReview of FDA citations related to data i
 ntegrity\n\nLearning Objectives:\n\nUnderstand the current regulatory 
 position on data integrity\nDiscover the criteria for data integrity\n
 Recognize what needs to be addressed to ensure data integrity within a
  regulated GXP laboratory\nLearn about approaches to improve data inte
 grity in a laboratory environment\nPart 11 compliance\nFDA citations r
 elated to data integrity issues\n\nWho Will Benefit:\n\nQuality Contro
 l Personnel & Management\nManufacturing Personnel & Management\nSenior
  Management\nRegulatory Affairs Personnel & Management\nQuality Assura
 nce Personnel & Management\n\n\n\n\nSpeaker ProfileDanielle DeLucy MS
 , is owner of ASA Training and Consulting, LLC which provides Pharmace
 utical and Biologics based companies with training and quality systems
  assistance in order to meet Regulatory compliance. Prior to this role
 , Danielle has been in the industry for 17 years serving in numerous Q
 uality Management Roles, such as the Director of Product Quality, the 
 oversight of Sterility Assurance practices and provided QA oversight o
 f numerous filling and packaging operations.Danielle began her QA care
 er as a Quality Control Pharmaceutical Microbiologist at a contract la
 boratory where she performed various tests for their clients. In the y
 ears after, she has held positions in the Quality management arena whi
 le increasing her responsibility.\nEvent link:\nhttps://www.compliance
 4all.com/webinar/-502993LIVE?channel=medtechiq-May_2020_SEO\nContact I
 nfo\nNetzealous LLC, DBA -Compliance4all\nEmail: support@compliance4Al
 l.com\nPhone: +1-800-447-9407\nWebsite: https://www.compliance4all.com
 /\n\n\n\nFor more information visit https://medtechiq.ning.com/events/
 implementation-and-management-of-gmp-data-integrity-1
DTSTART;TZID=America/New_York:20200520T100000
DTEND;TZID=America/New_York:20200520T130000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://www.compliance4all.com/webinar/implementation-and-mana
 gement-of-gmp-data-integrity-502993LIVE
URL:https://www.compliance4all.com/webinar/implementation-and-manageme
 nt-of-gmp-data-integrity-502993LIVE
CONTACT:8004479407
ORGANIZER:Compliance4all
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/2647295700?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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