Teleconference Audio CDs presented by Joshua Sharlin

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SOPs for SAS Programming: Tools for 21 CFR Part 11 Compliance

-Presented by Dr. Joshua Sharlin - March 21, 2011.

FDA's New Guidance on Electronic Source Documentation in Clinical Trials: A 30-Minute Update

-Presented by Dr. Joshua Sharlin - March 10, 2011.

FDA's New Safety Reporting Requirements: Changes for Clinical Trials.gov

-Presented by Dr. Joshua Sharlin - March 7, 2011.

FDA's New 510(k) Action Plan: Changes for 2011

-Presented by Dr. Joshua Sharlin - February 16, 2011.

Foreign Clinical Studies: Current FDA Regulations

-Presented by Dr. Joshua Sharlin - February 14, 2011.

FDAs New Guidance on Electronic Source Documentation in Clinical Trials: A 30-Minute Update.

-Presented by Dr. Joshua Sharlin - February 7, 2011.

Avoiding Statistical Errors in Clinical Trials: Preparing for FDA Review

-Presented by Dr. Joshua Sharlin - January 11, 2011.

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Understanding When Clinical Trial Information MUST be Entered Into ClinicalTrials.gov

-Presented by Dr. Joshua Sharlin - January 10, 2011.

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Writing SOPs: A Two-Part Teleconference, Part I: An Introduction

-Presented by Dr. Joshua Sharlin - December 13, 2010.

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Part II: Advanced Problems, Advanced Solutions

-Presented by Dr. Joshua Sharlin - December 15, 2010.

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New Guidance: What FDA Wants You to Know About When to Submit an IND

-Presented by Dr. Joshua Sharlin - December 20, 2010.

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What Needs To Be in a Product Submission: An FDA Reviewer's Perspective

-Presented by Dr. Joshua Sharlin - November 10, 2010.

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FDA's New Safety Reporting Requirements: Changes for Clinical Trials

-Presented by Dr. Joshua Sharlin - November 4, 2010.

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A New FDA Environment: It's Time to Examine Your Clinical Trial Analysis Data Sets

-Presented by Dr. Joshua Sharlin - October 14, 2010.

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Survey of FDA Reviewer Training: Understanding Reviewer Strategies, Tools, & Techniques for Approving Your Paper or Electronic Submission

-Presented by Dr. Joshua Sharlin - October 12, 2010.

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Part 11 Hasn't Gone Away

-Presented by Dr. Joshua Sharlin - September 23, 2010.

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510(k)s: The 70 Changes FDA Wants

-Presented by Dr. Joshua Sharlin - September 21, 2010.

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Implementing the FDA Guidance on the Integrated Summary of Effectiveness

-Presented by Dr. Joshua Sharlin - August 17, 2010.

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Adaptive Design: Why is FDA So Enthusiastic?

-Presented by Dr. Joshua Sharlin & William McCarthy - August 03, 2010.

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30-Minute Update: Whats an Applicable Clinical Trial? ClinicalTrials.gov & FDAs Current Definition

-Presented by Dr. Joshua Sharlin - July 8, 2010.

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Adverse Event Reporting SOPs for Medical Devices

-Presented by Dr. Joshua Sharlin - June 30, 2010.

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Adverse Event Reporting SOPs for Drugs & Biologics

-Presented by Dr. Joshua Sharlin - June 22, 2010.

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Internal FDA Standards for Reviewers

-Presented by Dr. Joshua Sharlin - May 19, 2010.

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FDA Compliant Information Technology: Software, Hardware & Social Media

-Presented by Dr. Joshua Sharlin - May12, 2010.

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Annual Reports: SOPs For Developing Content That Meets FDA Requirements

-Presented by Dr. Joshua Sharlin - May 5, 2010.

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SOPs for SAS Programming: Tools for 21 CFR Part 11 Compliance

-Presented by Dr. Joshua Sharlin - March 18, 2010.

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SOPs for Implementing a Risk-Based Approach to FDA Part 11 Compliance

-Presented by Dr. Joshua Sharlin - March 11, 2010.

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Computerized Systems Used In Clinical Investigations: FDA Guidance On Part 11 Regulations

-Presented by Dr. Joshua Sharlin - January 7, 2010.

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Testing SAS Programs: SOPs & Lessons Learned

-Presented by Dr. Joshua Sharlin - January 6, 2010.

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30-Minute Update Audio CD: ClinicalTrials.gov & FDA Requirements for a Certification of Compliance

-Presented by Dr. Joshua Sharlin - December 16, 2009.

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FDA Requirements for Entering Clinical Trial Results into ClinicalTrials.gov

-Presented by Dr. Joshua Sharlin - December 3, 2009.

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FDA's New Guidance & Enforcement: Company Websites, Email & Online Advertising

-Presented by Dr. Joshua Sharlin - September 10, 2009.

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Adaptive Design & Bayesian Statistics: New Trends in Clinical Trial Design That Speed Up FDA Approval

-Presented by Dr. Joshua Sharlin, William McCarthy; and Judith Quinlan - August 13, 2009.

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ClinicalTrials.gov & FDA Requirements for a Certification of Compliance

-Presented by Dr. Joshua Sharlin - July 22, 2009.

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Auditing Information Systems: Are You & Your Vendors Meeting FDA Expectations?

-Presented by Dr. Joshua Sharlin - June 4, 2009.

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Problems with ClinicalTrials.gov: FDA Meeting Summary

-Presented by Dr. Joshua Sharlin - April 30, 2009.

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30-Minute Update: A New Regulatory Strategy for Faster & Cheaper Global Clinical Trials

-Presented by Dr. Joshua Sharlin & Michael Sobczyk - November 19, 2008.

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30-Minute Update Audio CD. SOP on SOPs: Increase Your FDA Knowledge In 30 Minutes

-Presented by Dr. Joshua Sharlin - June 12, 2008.

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Submitting Clinical Trial Data: FDA Requirements That Began December 27, 2007

-Presented by Dr. Joshua Sharlin - April 28, 2008.

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Electronic Submissions: What’s New In Data Standards, Guidances & Third Party Support

-Presented by Dr. Joshua Sharlin - October 30, 2007.

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Good Review Management: FDA Internal Standards & Expectations of Industry

-Presented by Dr. Joshua Sharlin - June 26, 2007.

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Clinical Information Strategy: How To Learn More From Legacy Studies To Support Your Current Research

-Presented by Dr. Joshua Sharlin - April 24, 2007.

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Understanding FDA's Updated Package Insert Requirements for Drugs & Biologics: An Overview, Suggested SOPs & Implementation.

-Presented by Dr. Joshua Sharlin - March 27, 2007.

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Electronic Submissions: Will FDA Require eSubs & Outsource eSub Infrastructure?

-Presented by Dr. Joshua Sharlin - January 16, 2007.

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SAS Secrets Revealed

-Presented by Dr. Joshua Sharlin - Part 1: Tuesday October 31, 2006 - Part 2: Thursday 2, 2006.

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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.

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FDA Loses Pivotal Utah Medical Court Case: What Happened & Why

-Presented by Dr. Joshua Sharlin on December 13, 2005.

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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.