My 40 Classes
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 50-75 page handout.
Understanding FDA Reviewers and 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 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
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”?
Clinical Trials 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
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?
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
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
Medical Devices
- FDA’s New 510(k) Action Plan
- 510(k)s: The 70 Changes FDA Wants
- Adverse Event Reporting SOPs for Medical Devices
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 Costs
How to Write Standard Operating Procedures (SOPs)
- Writing SOPs Part I: An Introduction
- Writing SOPs Part II: Advanced Problems, Advanced Solutions
- SOP on SOPs
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
Generic Biologics
- Report on FDA Meeting About Follow-On Proteins (i.e., Generic Biologics))