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UID:c4408b326f6a6dceaedbc3d3084cea47@mivado.com
SUMMARY:Data Integrity for Effective Data Governance in Biopharma
DESCRIPTION:Implementing Data Integrity for Effective Data Governance in Bi
 opharma\nDescription\n\n\n\nData Integrity is a fundamental principle of Go
 od Manufacturing Practices (GMP). Over the past four years\, both the FDA a
 nd European inspectors have reported numerous citations related to data int
 egrity.  Many US Warning Letters and EU Non-Compliance Reports deal with s
 erious Data Integrity violations. Data Integrity questions have been and wi
 ll continue to be the focus of many GMP inspections.\n\n\n\nWhy should you 
 attend\nAs a consequence\, international authorities – FDA\, EMA\, PIC/S\
 , WHO\, MHRA - published guidance documents to describe the regulatory expe
 ctations of Data Integrity. Although not all guidelines are intended to imp
 ose an additional regulatory burden on the regulated companies\, a lot of u
 ncertainty predominates the pharmaceutical industry on how to implement the
 se requirements into the daily business.\nObjectives\n\nGet familiar with t
 he current regulatory requirements on data integrity and how regulators ref
 ine these requirements\nGet a deeper understanding of what FDA and European
  inspectors expect from pharmaceutical companies regarding Data Integrity\n
 Learn how to implement the (new) regulatory requirements on Data Integrity 
 into your Pharmaceutical Quality System\nLearn how to prepare your company 
 for a successful inspection regarding Data Integrity\nUnderstand how to est
 ablish an effective Data Governance System\nLearn how to investigate Data I
 ntegrity issues in your company\n\nWho Should Attend\n\nManagers and staff 
 from Manufacturing\, QC/QA\, and Analytical Development Laboratories of pha
 rmaceutical companies\n Contract Research Organisation and Contract Manufa
 cturing Organisation manufacturing\, laboratory\, and QA personnel\n Audit
 ors (internal and external) are responsible for performing self-inspections
  or external audits and need to understand and assess data integrity\n\nEdu
 cation Approach\n\n\nThis training is based on both theory and best practic
 es used in the implementation and management of GDP\n\nLecture sessions are
  illustrated with examples based on case studies\n\nPractical exercises are
  based on a case study\, which includes role-playing and discussions\n\n\nS
 peaker\n\nKossi Molley\, Chgemiste\; LSSBB: PMP
LOCATION:Online
DTSTAMP:20260926T223531Z
DTSTART:20261020T130000Z
DTEND:20261020T200000Z
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