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International Council for Harmonization (ICH)
Part 120 - Hazard Analysis and Critical Control Point (HACCP) Systems
Includes EU Clinical Trial Directive
- Chapter 9 - Self Inspection
com for Course description
GCLP Good Clinical Laboratory Handbook - 4.5x7.5 ICH Q7 International Council for Harmonization (ICH)US 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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