Teleconference Audio CDs presented by Joshua Sharlin
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Teleconference Audio CD: Computerized Systems Used In Clinical Investigations: FDA Guidance On Part 11 Regulations
-Presented by Dr. Joshua Sharlin - July 16, 2008.
30-Minute Update Audio CD. ClinicalTrials.gov & FDA Requirements for a Certification of Compliance
-Presented by Dr. Joshua Sharlin - July 10, 2008.
30-Minute Update Audio CD. SOP on SOPs: Increase Your FDA Knowledge In 30 Minutes
-Presented by Dr. Joshua Sharlin - June 12, 2008.
Foreign Clinical Studies: New FDA Regulations
-Presented by Dr. Joshua Sharlin - May 29, 2008.
Adverse Event Reporting SOPs for Drugs & Biologics
-Presented by Dr. Joshua Sharlin - May 8, 2008.
Adverse Event Reporting SOPs for Medical Devices
-Presented by Dr. Joshua Sharlin - May 6, 2008.
Submitting Clinical Trial Data: FDA Requirements That Began December 27, 2007
-Presented by Dr. Joshua Sharlin - April 28, 2008.
Annual Reports: SOPs For Developing Content That Meets FDA Requirements
-Presented by Dr. Joshua Sharlin - April 8, 2008.
Good Review Management: FDAs Internal Standards & Expectations of Industry
-Presented by Dr. Joshua Sharlin - March 11, 2008.
Testing SAS Programs: SOPs & Lessons Learned
-Presented by Dr. Joshua Sharlin - February 6, 2008.
What Needs To Be In a Product Submission: An FDA Reviewers Perspective
-Presented by Dr. Joshua Sharlin - January 10, 2008.
Writing SOPs Part II
-Presented by Dr. Joshua Sharlin - December 13, 2007.
Writing SOPs Part I
-Presented by Dr. Joshua Sharlin - December 11, 2007.
Auditing Information Systems: Are You & Your Vendors Meeting FDA Expectations?
-Presented by Dr. Joshua Sharlin - November 29, 2007.
Computerized Systems Used In Clinical Investigations: FDA’s Most Recent Guidance On Part 11 Regulations
-Presented by Dr. Joshua Sharlin - November 8, 2007.
Electronic Submissions: What’s New In Data Standards, Guidances & Third Party Support
-Presented by Dr. Joshua Sharlin - October 30, 2007.
SOPs for Implementing a Risk-Based Approach to FDA Part 11 Compliance
-Presented by Dr. Joshua Sharlin - October 10, 2007.
Survey of FDA Reviewer Training: Understanding Reviewer Strategies, Tools, and Techniques for Approving Your Paper or Electronic Submission
-Presented by Dr. Joshua Sharlin - September 20, 2007.
SOPs For SAS Programming: Tools For 21 CFR Part 11 Compliance
-Presented by Dr. Joshua Sharlin - September 12, 2007.
Adverse Reaction Reporting SOPs for Medical Devices
-Presented by Dr. Joshua Sharlin - August 30, 2007.
Adverse Event Reporting SOPs for Drugs & Biologics
-Presented by Dr. Joshua Sharlin - August 23, 2007.
Adaptive Design & Bayesian Statistics: New Trends in Clinical Trial Design That Speed Up FDA Approval
-Presented by Dr. Joshua Sharlin - August 16, 2007.
Avoiding Statistical Errors in Clinical Trials: Preparing for FDA Review
-Presented by Dr. Joshua Sharlin on July 26, 2007.
Good Review Management: FDA Internal Standards & Expectations of Industry
-Presented by Dr. Joshua Sharlin - June 26, 2007.
Computerized Systems Used in Clinical Investigations: FDAs Most Recent Guidance on Part 11 Regulations
-Presented by Dr. Joshua Sharlin - June 7, 2007.
Clinical Information Strategy: How To Learn More From Legacy Studies To Support Your Current Research
-Presented by Dr. Joshua Sharlin - April 24, 2007.
Understanding FDA's Updated Package Insert Requirements for Drugs & Biologics: An Overview, Suggested SOPs & Implementation.
-Presented by Dr. Joshua Sharlin - March 27, 2007.
Electronic Submissions: Will FDA Require eSubs & Outsource eSub Infrastructure?
-Presented by Dr. Joshua Sharlin - January 16, 2007.
SAS Secrets Revealed
-Presented by Dr. Joshua Sharlin - Part 1: Tuesday October 31, 2006 - Part 2: Thursday November 2, 2006.Part 1:
Part 2:
Disagreeing With The FDA: A Shot In The Arm or A Shot In The Foot?
-Presented by Dr. Joshua Sharlin and Daniel Jarcho on April 20, 2006.
FDA Loses Pivotal Utah Medical Court Case: What Happened & Why
-Presented by Dr. Joshua Sharlin on December 13, 2005.
FDA Electronic Submissions Part 2: How to Build an eSub
-Presented by Dr. Joshua Sharlin and Michael Palmer on February 3, 2005.
FDA Electronic Submissions Part I: Essential Requirements and Standards.
-Presented by Dr. Joshua Sharlin and Michael Palmer on February 1, 2005.
Using Available Tools For SAS Part 11 Compliance: How To Reduce Costs of SAS Installation and Maintenance
-Presented by Dr. Joshua Sharlin on November 16, 2004.
What Have You Missed? 2003 FDA Drug Guidance (& More)
-Presented by Dr. Joshua Sharlin on September 25, 2003.
FDA's New Safety Reporting Requirements: Complexitites and Costs
-Presented by Dr. Joshua Sharlin on May 29, 2003.
Is Part 11 Going Away?
-Presented by Dr. Joshua Sharlin on August 12, 2003.