FDA
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$179
Preparing for Changes to ICH GCP E6(R3) and ICH E8(R1) – Readying for Risk MitigationSandra “SAM” SatherOn-Demand -
$279
FDA REMS Inspection Guide: Audit Preparedness Best PracticesPenelope Przekop, MSQA, RQAP-GCPOn-Demand -
$279
The MHRA Data Integrity Guidance Clarified: What it Means for Industry & PatientsBetsy FallenOn-Demand -
$279
How FDA and MHRA Decide Which Drug Facilities to Inspect – and at What FrequencyJerry ChapmanOn-Demand -
$279
A Holistic Approach to External GMP Surveillance, GMP Training, and Quality Knowledge ManagementJerry ChapmanOn-Demand -
$279
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$279
Note to File 101: Critical Steps for When, and When Not To, Engage in NTFsLuisa Monica, Jackie MorrillOn-Demand -
$279
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$1199
-
$279
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$279
Investigator Oversight Plans: Essentials for Inspection Readiness Post ICH GCP E6 (R2) AddendumSandra “SAM” SatherOn-Demand -
$279
CAPA and Root Cause Analysis: Essentials Post ICH GCP E6 (R2) AddendumSandra “SAM” SatherOn-Demand -
$279
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$279
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$279
Certified Copies and ALCOA-C: Essentials Post ICH GCP E6 (R2) AddendumSandra “SAM” SatherOn-Demand -
$279
