21 CFR Part 11, §11.10 and §11.50
21 CFR Part 11, §11.10 and §11.50 (ecfr.gov) (20 min)
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FDA Part 11 Scope and Application guidance
Tuesday · after 21 CFR Part 11, §11.10 and §11.50
FDA Part 11 Scope and Application guidance (2003), sections III-IV (25 min)
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In: LABLOOP-W33 Notebook
MHRA GxP Data Integrity Guidance
Tuesday · after FDA Part 11 Scope and Application guidance
MHRA GxP Data Integrity Guidance (2018), definitions section (30 min)
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In: LABLOOP-W33 Notebook
FDA, "Data Integrity and Compliance With Drug CGMP: Questions and Answers"
Saturday sandbox
FDA, "Data Integrity and Compliance With Drug CGMP: Questions and Answers" (guidance, December 2018)
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In: LABLOOP-W33 Notebook
FDA "Computer Software Assurance for Production and Quality System Software" guidance
Saturday sandbox · after FDA, "Data Integrity and Compliance With Drug CGMP: Questions and Answers"
FDA "Computer Software Assurance for Production and Quality System Software" guidance (verify final status and date)
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ICH E6(R3) Good Clinical Practice, data governance sections
Saturday sandbox · after FDA "Computer Software Assurance for Production and Quality System Software" guidance
ICH E6(R3) Good Clinical Practice, data governance sections (only if a clinical client appears)
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In: LABLOOP-W33 Notebook
eLabFTW documentation
Saturday sandbox · after ICH E6(R3) Good Clinical Practice, data governance sections
eLabFTW documentation — doc.elabftw.net (installation and API)
In: LABLOOP-W33 Notebook
Coursera Research Data Management and Sharing
Saturday sandbox · after eLabFTW documentation
Coursera Research Data Management and Sharing (UNC/Edinburgh), modules on data storage and preservation
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In: LABLOOP-W33 Notebook