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#07 USP <1220> & ICH Q14/Q2(R2) - Part I
Empower supports USP <1220> Analytical Procedure Life Cycle and upcoming ICH Q14/Q2(R2) guidelines - development, including QbD integration and DoE approach for efficient method development in pharma labs.
33:10
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#08 USP <1220> & ICH Q14/Q2(R2) – Part II
Empower supports USP <1220> Analytical Procedure Life Cycle and upcoming ICH Q14/Q2(R2) guidelines - method validation using Empower Method Validation Manager (MVM) and ongoing verification with trend reporting—all in one platform.
34:53
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#09 Compliance & Data Integrity
The latest Empower CDS features that enhance compliance and data integrity. Learn about updates since E3 FR5 and how to leverage settings for regulated labs to maintain compliance effortlessly.
30:59
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#15 Audit Trail Review
Apply a risk-based approach to audit trail review in Empower CDS. Understand lab business processes, identify user interaction risks, and define what to review, who should review it, and when—ensuring compliance and data integrity.
29:09
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#18 System Suitability
Calculate suitability parameters, use interactive tools, create control charts, and understand updates aligned with USP (621) Chromatography. Ensure compliance and optimize your workflows.
35:36
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#26 Computer System Validation (CSV)
Risk-based computer system validation strategies for regulated environments. Discover how to align with FDA 21 CFR Part 11 and EU Annex 11, ensure data integrity, streamline audits, and leverage scalable service models for compliance.
30:56
