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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

	Adverse Event Reporting
	Two of Dr. Sharlin’s Training Classes
	Class Title	Description
1	A Survey of Adverse Event Reporting Requirements for Drugs and Biologics	A summary of FDA’s regulations about AE reporting for drugs and biologics. Advice on how to improve reporting processes. INCLUDES 8 MODEL SOPs..
2	A Survey of Medical Device Adverse Event Reporting Requirements	A summary of FDA’s regulations about medical device AE reporting. How to improve reporting compliance. INCLUDES 9 MODEL SOPs.