MY 40 CLASSES

FDA Related

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Medical Devices

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SAS Programming

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My Vast Teaching Experience Allows Me To Present Complex Information In Plain Words To A Judge And Jury. Over 50,000 People From More Than A Thousand FDA Regulated Companies Have Paid To Hear The 40 Classes I Developed And Taught

Note: Each Bullet Point Is A class Title. Classes Are A 60 Minute Presentation Using A 50-70 Page Handout

FDA

Understanding FDA Reviewers & the Review Process

  • What Needs to Be in a Product Submission – An FDA Reviewer’s Perspective
  • FDA’s Financial Disclosure Guidance for Clinical Investigators
  • Survey of FDA Reviewer Training: Understanding Reviewer Strategies, Tools, & Techniques for Approving Your Submission
  • Good Review Management: FDA’s Internal Standards and Expectations of Industry
  • Disagreeing With FDA: A Shot in the Arm or a Shot in the Foot?

FDA

FDA Requirements for Reports, Labels and Advertising

  • Annual Reports: Standard Operating Procedures for Developing Content That Meets FDA Requirements
  • Understanding FDA’s New Package Insert Requirements for Drugs and Biologics
  • FDA’s New Guidance and Enforcement: Company Web Sites, Email & Online Advertising

FDA

The FDA Database: ClinicalTrials.gov

  • Submitting Clinical Trial Data: FDA Requirements
  • FDA Requirements For Entering Clinical Trial Results Into ClinicalTrials.gov
  • Certification of Compliance
  • What’s an “Applicable Clinical Trial”?

FDA

Clinical Trial Conducted Outside The U.S.

  • No More Form 1572s – A New Regulatory Strategy For Faster & Less Expensive Global Clinical Trials
  • Foreign Clinical Studies: New FDA Regulations

FDA

How to Analyze Trial Results – Help for Non-Statisticians

  • Avoiding Statistical Errors in Clinical Trials: Preparing for FDA Review
  • New Trends in Clinical Trial Design That Encourage FDA Approval
  • Adaptive Design: Why is FDA so Enthusiastic?

FDA

Part 11 Electronic Record Compliance and Software Validation

  • Auditing Information Systems: Are You and Your Vendors Meeting FDA Expectations
  • Implementing a Risk Based Approach to Part 11 Compliance
  • Computerized Systems Used in Clinical Trials: Improving your Compliance
  • Auditing for Part 11 Compliance: It Hasn’t Gone Away
  • FDA’s New Guidance on Electronic Source Documentation in Clinical Trials

FDA

Medical Devices

  • FDA’s New 510(k) Action Plan
  • 510(k)s: The 70 Changes FDA Wants
  • Adverse Event Reporting SOPs for Medical Devices

FDA

Safety Reporting for Drugs

  • FDA’s Safety Reporting Requirements: Changes for Clinical Trials
  • Adverse Event Reporting Standard Operating Procedures for Drugs and Biologics
  • FDA’s New Safety Reporting Requirements: Complexities and Cost

FDA

Improving the Analysis and Presentation of Study Results

  • A New FDA Environment: It’s Time to Examine Your Clinical Trial Analysis Data Sets
  • Implementing FDA’s Guidance on the Integrated Summary of Effectiveness (ISE)
  • Clinical Information Strategy

FDA

How to Write Standard Operating Procedures (SOPs)

  • Writing SOPs Part I: An Introduction
  • Writing SOPs Part II: Advanced Problems, Advanced Solutions
  • SOP on SOPs

OTHER

Generic Biologics

  • Report on FDA Meeting About Follow-On Proteins (i.e., Generic Biologics))

OTHER

SAS Programming

  • Understanding SAS Programming Internals, Part 1
  • Understanding SAS Programming Internals, Part 2
  • Standard Operating Procedures for SAS Programming: Tools for Part 11 Compliance
  • Testing SAS Programs: A Key Element of Part 11 Compliance
  • Using Available Tools: How to Reduce Part 11 Compliance Costs for SAS Installation, Maintenance and Programming

Sharlin Consulting, LLC.

Joshua Sharlin, PH.D

 

jsharlin@pipeline.com

Cell: (410) 231-8900

Washington D.C.

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