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International Council for Harmonization (ICH)
Includes EU Clinical Trial Directive
- Chapter 9 - Self Inspection
Part 113 - Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers
GCLP Good Clinical Laboratory Handbook - 4.5x7.5 ICH Q7 com for Course descriptionUS FDA Title 21 CFR Parts 21 CFR Part 11 Electronic Records with Scope and Application 21 CFR Part 58 Good Laboratory Practice 21 CFR Part 312 Investigational New Drug Application 21 CFR Part 314 Applications for FDA Approval to Market a New Drug 42 CFR Part 493 Laboratory Requirements (HHS) International Council for Harmonisation ICH E6(R3) Good Clinical Practice ICH Q1A(R2) Stability Testing of New Drug Substances ICH Q1C Stability Testing for New
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