Sharlin Consulting

Home
What's
New
About
Dr. Sharlin
Regulatory
Services
Software
Services
Training
Classes
Audioconf
Documents
Useful
FDA Docs
Newsletter
Contact
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

What's New On SpeedUpFDA.com
	Date	What's New
1	October 2009	Added documents to be downloaded as extra information for my three October 2009 audioconferences. See tab "Audioconference Documents".
2	September 2009	Added tab, "Audioconf docs"
3	September 2009	Added tab, "Docs of Interest"
4	August 2009	New version of SpeedUpFDA.com is available on the web