Voices In Validation

Managing data integrity in GCP environment

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Stacey Bruzzese welcomes back Chris Wubbolt, Principal of QACV Consulting, to the show. Today, Stacey and Chris will be discussing how to manage data integrity expectations in GCP environment.

  • Current guidelines that apply to Data Integrity
  • What are the most important data integrity issues?
  • The need for original documents for investigations
  • What should SOP’s entail for firms to manage data risks?
  • Specific regulations for eRecords and eSignatures
  • Use of electronic documents for data integrity
  • What have companies gone through during an audit of this type?

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    • Investigations Operations Manual  2020 - https://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM607759.pdf
  • Guide to Inspections of Pharmaceutical Quality Control Laboratories - https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/pharmaceutical-quality-control-labs-793
  • Guidances and Manuals on Pharmaceutical Quality - https://www.fda.gov/drugs/pharmaceutical-quality-resources/guidances-and-manuals-pharmaceutical-quality
  • MHRA Guidance - Good clinical practice for clinical trials - https://www.gov.uk/guidance/good-clinical-practice-for-clinical-trials
  • MHRA Inspection Toolkit - http://www.ct-toolkit.ac.uk/routemap/mhra-inspection/
  • MHRA Inspectorate Computer System Validation – GCP - https://mhrainspectorate.blog.gov.uk/2017/04/20/computer-system-validation-gcp/
  • E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r2-good-clinical-practice-integrated-addendum-ich-e6r1

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    Chris has over 25 years’ experience in regulated industry and has provided compliance, quality assurance and computer validation consulting services. He remains current in industry trends and requirements and frequently speaks or provides workshops at leading industry conferences and programs. Chris has a master’s Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering, along with a Six Sigma Black Belt Certification.

    Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

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