Sharlin Consulting

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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

Commercial Software Products - Create 21 CFR Part 11 Compliance Documentation
Description	Advantages of Hiring Dr. Sharlin	Class I Developed So Others Can Learn From My Experience ⁽¹⁾
Companies developing and selling software products to FDA-regulated companies may be unfamiliar with FDA expectations and customer’s needs. My services include writing SOPs and creating documentation of compliance for the software vendor and their potential customers.	Applying my 15 years of experience in software development, if necessary, I can reverse engineer the information and documentation a computer system requires to be 21 CFR Part 11 compliant.	“Auditing Information Systems – Are You and Your Vendors Part 11 Compliant?”
⁽¹⁾ Contact me and the table of contents from any class can be emailed to you