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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

Conduct GCP⁽¹⁾ Audits of CROs and Sponsors – Consulting Services
Description	Advantages of Hiring Dr. Sharlin	Class I Developed So Others Can Learn From My Experience ⁽²⁾
Conduct audits related to compliance (see the specifics in #1 above) Sponsors hire me to investigate the CROs they have hired or are thinking about hiring CROs hire me to conduct mock audits, i.e., conduct an audit as if I was a sponsor (i.e., a potential customer) and write a gap analysis report	Because I have over 10 years of experience doing industrial strength software development, I audit from two perspectives: (1) as a GCP compliance expert and (2) as an expert in software development. I can evaluate the quality and completeness of any work related to information technology. Because most auditors do not have an IT background they only evaluate compliance.	“Auditing Information Systems: Are You and Your Vendors Meeting FDA Compliance Expectations?”
⁽¹⁾ GCP – Good Clinical Practice
⁽²⁾ Contact me and the table of contents from any class can be emailed to you