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FDA & Global Regulatory Training Support » » »


We provide cost-effective, in-house training support to help biotechnology companies and clinical research teams meet FDA and Global training requirements.

Our Most Popular Training Topics Include:

» FDA Quality System Regulation - cGMP/QSR 21 CFR Part 820

» FDA Inspection Readiness: Prepare Your Company Before FDA Arrives

» FDA Medical Device Reporting (MDR) - 21 CFR Part 803

» Health Hazard Evaluations (HHE) For Recalls - An FDA Requirement

» International Quality Systems - Current ISO 13485

» 21 CFR Part 11: Requirements & Validation Process Overview

» Risk Management for Medical Devices - Current ISO 14971

»Design Control Requirements & Tips - 21 CFR Part 820(a)-(j)

» GLP & GxP Overview - For Academic Research PIs & Their Lab Teams

» Good Clinical Practice - Current ICH-GCP

» Clinical Trial Monitoring: Best Practices For Optimal Outcomes

» Preparing For FDA Inspections: Gap Assessments & SME Readiness

» FDA IDE - Investigational Device Exemption - 21 CFR Part 812

» FDA IND - Investigational New Drug - 21 CFR Part 312

» FDA 510(k) Submission Preparation & FDA Review Process Tips

» FDA PMA - Premarket Approval Process - 21 CFR Part 814

» Preparing For An FDA BIMO Inspection: Is Your Study Team Ready?

Please contact us at [email protected] to let us know what your training needs are. We'll customize a cost-efficient training program for your R&D/QA team, your Institutional Review Board (IRB) and / or your clinical research team.