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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

	SAS Software
	Three of Dr. Sharlin’s Training Classes
	Class Title	Description
1	How To Increase SAS Programming Quality and Efficiency, Part 1 of 2	A discussion about understanding how SAS works, including the program data vector, SAS supervisor and compile time and execution time statements.
2	How To Increase SAS Programming Quality and Efficiency, Part 2 of 2	An advanced discussion about understanding how SAS works. Explanation of the rules for how missing values are set and how observation pointers are moved.
3	SAS Programming: Model SOPs and Other Tools for Part 11 Compliance	A discussion about developing and using standard operating procedures needed by a SAS programming group to be in compliance FDA's electronic record and electronic signature regulations as described in 21 CFR Part 11. INCLUDES 15 MODEL SOPs.