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	Podcast:		Voices In Validation
	Episode:		Managing data integrity in GCP environment
	Category:		Science & Medicine
	Duration:		00:40:39
	Publish Date:		2020-04-21 13:27:31
	Description:		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? 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 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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