Sharlin Consulting
FDA Compliance Consulting and Training
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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
Audioconference Title
FDA's New Guidance & Enforcement: Company Websites, Email & Online Advertising
Audioconference Date
Thursday September 10, 2009. 1:00 pm to 2:30 pm
Audioconference Description
An overview of recent FDA actions affecting Internet communication about products and product risk.
Instructor information
Contact me for assistance
regarding the application of this information
Joshua Sharlin, Ph.D.
Sharlin Consulting
Tel +1-301-570-1107
jsharlin@pipeline.com
www.speedupfda.com
These documents supplement information presented in the audioconference
Document Title
Pages
Check here to Download
1
FDA Guidance for Industry - Presenting Risk Information in Prescription Drug and Medical Device Promotion
27
2
RTCRM white paper - An Eye on Google: Re-engaging with digital marketing in response to recent FDA warnings
16
3
RTCRM white paper - Bridging the Digital Divide on Presenting Risk Information
18
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