Events Tagged "warning letters"

21 CFR Part 11 and Annex 11 Compliance

This 21 CFR Part 11 compliance training will guide you through the concept of part 11 and explanation of its 3 primary areas SOPs, Product features and Validation (10 step risk based approach).

21 CFR Part 11 and Annex 11

This webinar details both regulations and provides details for implementing computerized systems.

Excel Spreadsheet Validation to Eliminate 483s

This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.

21 CFR Part 11 and Annex 11

21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits - Webinar By GlobalCompliancePanel

FDA QSR – Regulations and Warning Letters

This webinar explains concepts required for a calibration program that satisfies FDA's Quality System Regulation (QSR), ISO 13485, and ISO 9001.

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