FDASmart Inc., FDA Inspection Training Courses, FDA Consultant, FDA Compliance, FDA Audit, FDA Consulting

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Additions to FDASmart.com

Overview

Overview Building better FDA submissions--

Mission Statement Training Experience

Write SOPs GCP audit of CROs and Sponsors Solve Regulatory Problems Write Protocols and Study Reports Improve Submissions (Drugs, Biologics, and Devices) Audit Safety Compliance

In-House Computer Systems - Part 11 Compliance Commercial Software Products - Part 11 Compliance Improve SAS Programming

Part 11 Compliance (3 Classes) SOPs (2 Classes) Regulatory Affairs (7 Classes) Statistical Analysis (2 Classes) SAS Programming (3 Classes) Adverse Event Reporting (2 Classes) Entering Data into ClinicalTrials.gov (4 Classes)

In Progress

Mission Statement

FDASmart Inc.

Develop SOPs and documentation required to pass an audit
Create ideas and implement strategies, to reduce FDA approval time
Assist in understanding FDA’s expectations
Meet FDA’s compliance regulations
Produce information that FDA reviewers can quickly understand and agree with
Improve the knowledge, skill and insight of your staff