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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

Audit Safety Compliance – Consulting Services
Description	Advantages of Hiring Dr. Sharlin	Classes I Developed So Others Can Learn From My Experience ⁽¹⁾
FDA is placing a growing emphasis on safety reporting. There are numerous deadlines to meet and reports to write. FDA’s definition of key terms is also important.	I can conduct a compliance gap analysis, write any missing SOPs and organize your efforts so your safety compliance efforts are complete and correct.	“A Survey of Adverse Event Reporting Requirements for Drugs and Biologics” “A Survey of Medical Device Adverse Event Reporting Requirements”
⁽¹⁾ Contact me and the table of contents from any class can be emailed to you