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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

Improve the Quality and Efficiency of SAS Programming – Consulting Services
Description	Advantages of Hiring Dr. Sharlin	Classes I Developed So Others Can Learn From My Experience ⁽¹⁾
Writing SAS code in an FDA regulated environment requires special program documentation and coding techniques. In addition, the installation and maintenance of SAS must be carefully executed.	Because I taught programming for SAS Institute, and used SAS while working as an FDA reviewer, I have special insight into how to effectively use SAS software in an FDA regulated environment.	“How to Increase SAS Programming Quality and Efficiency, Parts 1 and 2” “SAS Programming: Model SOPs and Other Tools for Part 11 Compliance”
⁽¹⁾ Contact me and the table of contents from any class can be emailed to you