Product Category

Trial Master File (TMF) – Clinical Trial Systems and FDA Expectations

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Measurement, Analysis, and Improvement for safe and Effective Medical Devices

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How to Prepare for and Host a FDA Inspection and Respond to 483’s

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ISO 14971:2019 Medical Device Hazards and Risk Management – All you need to know

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Data Integrity and Privacy – compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

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3-Hour Virtual Seminar on Complaint Handling and Medical Device Reporting and Recalls

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Good Documentation Practices – What Helps Make Your Controlled Documents Compliant

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FDA’s Latest UDI Labeling Requirements

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Getting R&D on Board with Risk Analysis

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3-Hours Virtual Seminar – Technical Writing for the Regulated Industries

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3-Hour Virtual Seminar on Aseptic Technique and Cleanroom Behavior – Avoiding Human

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Quality Control for Analytical Materials used in Microbiology Laboratories

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Handling Medical Device Complaints & CAPA

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Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

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3-Hour Virtual Seminar on GCP ICH E6 R2 Addendum and Impact on Selection and Managing Vend

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