Sharlin Consulting
FDA Compliance Consulting and Training
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Dr. Sharlin
Additions to SpeedUpFDA.com
Overview
10Sep09, FDA-Internet
22Sep09, Internal FDA Standards
24Sep09, AE Reporting for Drugs & Biologics
8Oct09, AE Reporting for Devices
Overview
Building better FDA submissions--
Mission Statement
Seven Benefits when Hiring Dr. Sharlin
Training Experience
Resume
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
View This Month's Training Classes
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
The Sharlin Consulting newsletter is under development.