FDA
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Preparing for Changes to ICH GCP E6(R3) and ICH E8(R1) – Readying for Risk Mitigation
$179.00 – $1,695.00 Select options -
FDA REMS Inspection Guide: Audit Preparedness Best Practices
$279.00 – $2,550.00 Select options -
The MHRA Data Integrity Guidance Clarified: What it Means for Industry & Patients
$279.00 – $2,550.00 Read more -
How FDA and MHRA Decide Which Drug Facilities to Inspect – and at What Frequency
$279.00 – $2,550.00 Select options -
A Holistic Approach to External GMP Surveillance, GMP Training, and Quality Knowledge Management
$279.00 – $2,550.00 Select options -
FDA Compliant QC and QA Practices: Creating a Perfect, Audit-Ready QMS
$279.00 – $2,550.00 Select options -
Note to File 101: Critical Steps for When, and When Not To, Engage in NTFs
$279.00 – $2,550.00 Read more -
Implementing the ASTM E2500 Validation Method: 10 Years of Key Learnings
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Sale!
ICH GCP E6 (R2) Refresher Training Bundle
$1,199.00 Add to cart -
Monitoring Plan Development: Post ICH GCP E6 (R2) Addendum
$279.00 – $2,550.00 Select options -
Investigator Oversight Plans: Essentials for Inspection Readiness Post ICH GCP E6 (R2) Addendum
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CAPA and Root Cause Analysis: Essentials Post ICH GCP E6 (R2) Addendum
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ICH E6 Addendum R2 Team Training and Action Planning
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CRO Oversight Post ICH GCP E6 (R2) Addendum
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Certified Copies and ALCOA-C: Essentials Post ICH GCP E6 (R2) Addendum
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How To Establish The Number of Runs Required For Process Validation
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