Product Category

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

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

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

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

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

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

Good Documentation Practices – What Helps Make Your Controlled Documents Compliant

FDA’s Latest UDI Labeling Requirements

Getting R&D on Board with Risk Analysis

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

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

Quality Control for Analytical Materials used in Microbiology Laboratories

Handling Medical Device Complaints & CAPA

Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

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

1 2 3 40