WEBINARS

Design Control for Medical Devices and Combination Products

Design Control for Medical Devices and Combination Products

Reclassification of Software Automated Medical Devices

Reclassification of Software Automated Medical Devices

GCP Risk Management and Risk-Based Monitoring

GCP Risk Management and Risk-Based Monitoring

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Preapproval Inspection and Submission to the FDA

Preapproval Inspection and Submission to the FDA

Data Integrity and Human Error

Data Integrity and Human Error

In Depth Testing of Computer Systems Regulated by FDA

In Depth Testing of Computer Systems Regulated by FDA

Drug Master Files (DMFs) – Understanding and Meeting Your Global Regulatory and Processing Responsibilities

Drug Master Files (DMFs) – Understanding and Meeting Your Global Regulatory and Processing Responsibilities

FDA Labeling and UDI Essentials for Medical Products

FDA Labeling and UDI Essentials for Medical Products

FDA’s 21 CFR Part 11 Add-on Inspections

FDA’s 21 CFR Part 11 Add-on Inspections

Batch Record Review and Product Release

Batch Record Review and Product Release

CSA in Practice: How to Build Defensible Evidence the FDA Actually Wants to See

CSA in Practice: How to Build Defensible Evidence the FDA Actually Wants to See

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