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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

	21 CFR Part 11 Compliance (electronic records & electronic signatures)
	Three of Dr. Sharlin’s Training Classes
	Class Title	Description
1	Auditing Information Systems: Are You and Your Vendors Meeting FDA Expectations?	A discussion about conducting an audit or preparing to be audited for compliance with 21 CFR Part 11 regulations (electronic records and electronic signatures.)
2	Computerized Systems Used in Clinical Investigations: FDA Guidance on Part 11 Regulations	A summary of new information in the final (May 2007) version of the guidance, “Computerized Systems Used in Clinical Trials” and how to improve compliance based on this new information.
3	SOPs for Implementing a Risk-Based Approach to FDA Part 11 Compliance	A review and discussion of FDA's risk assessment requirement for evaluating systems that support product quality, safety and record integrity.