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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

Training Classes Presented by Dr. Sharlin
To register, visit my audioconference partner FOI Services, Inc, www.foiservices.com
	Class Title	Class Date	Class Description
October 2009 Classes
1	Adverse Event Reporting SOPs for Medical Devices	Thursday October 8, 2009. 1:00 pm to 2:30 pm	A discussion about SOPs that organize and improve FDA compliance of medical device safety reporting efforts. Includes nine model SOPs
2	Avoiding Statistical Errors in Clinical Trials: Preparing for FDA Review	Tuesday October 20, 2009. 1:00 pm to 2:30 pm	A discussion of how to use statistics to improve the design, execution, and analysis of clinical trials.
3	What Needs to be in a Product Submission: An FDA Reviewer's Perspective	Wednesday October 21, 2009. 1:00 pm to 2:30 pm	A discussion of how FDA reviewers think and work -- and how to use that information to improve the structure and content of your submissions.
September 2009 Classes
1	FDA's New Guidance & Enforcement: Company Websites, Email & Online Advertising	Thursday September 10, 2009. 1:00 pm to 2:30 pm	An overview of recent FDA actions affecting Internet communication about products and product risk.
2	Internal FDA Standards for Reviewers	Tuesday September 22, 2009. 1:00 pm to 2:30 pm	A discussion of standards and processes meant to improve FDA performance and the quality of submissions produced by regulated industry.
3	Adverse Event Reporting SOPs for Drugs & Biologics	Thursday September 24, 2009. 1:00 pm to 2:30 pm	A discussion about SOPs that organize and improve FDA compliance of drug and biologic safety reporting efforts.