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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

Write SOPs Consulting Services
Description	Advantages of Hiring Dr. Sharlin	Classes I Developed So Others Can Learn From My Experience ⁽¹⁾
Write SOPs for activities related to software programming, data collection, data analysis, database validation, information reporting, statistics, computer infrastructure, or regulatory compliance including safety	I have vast SOP writing experience. Almost every month companies hire me to write, review or improve their SOPs. I specialize in creating SOP deliverables; information that documents SOP compliance.	“Writing SOPs, Part 1 - The Basics” “Writing SOPs, Part 2 – Advanced Problems, Advanced Solutions”.
⁽¹⁾ Contact me and the table of contents from any class can be emailed to you