Joshua Sharlin - SOP Teleconferences
Click on a title for more information.
Adverse Event Reporting SOPs for Drugs & Biologics
-Presented by Dr. Joshua Sharlin - September 24, 2009.
Topics of the Model SOPs Provided:
- IND safety reports
- IND annual reports
- Responsibilities for postmarketing safety reporting
- Required content for postmarketing safety reports
- Validation of electronic AE systems
- Data monitoring committees
- Statistical analysis of AE data
- MedDRA coding of AE data
SOPs for SAS Programming: Tools for 21 CFR Part 11 Compliance
-Presented by Dr. Joshua Sharlin - July 21, 2009.
Topics of the Model SOPs Provided:
- Initial install
- Validation Overview
- Requirements Specifications
- High Level Study Design
- Program Design
- Database Specifications
- Directory Structure
- Coding Conventions
- Log Review
- Change Control
- Debugging
- Testing
- Maintenance
- Transport Files
- Risk Assessment
Testing SAS Programs: SOPs and Lessons Learned
-Presented by Dr. Joshua Sharlin - March 12, 2009.
Topics of the Model SOPs Provided:
- Conducting a SAS log review, 7 pages
- SAS program change control, 10 pages
- Debugging SAS logic errors, 8 pages
- SAS testing, 7 pages
- Risk assessment of SAS programs, 10 pages
Annual Reports: SOPs for Developing Content Which Meets FDA Requirements. .
-Presented by Dr. Joshua Sharlin - February 3, 2009.
Topics of the Model SOPs Provided:
- Biologics Annual Reports
- Device Annual Reports before and after product approval
- IND Annual Reports
- Post-Approval Annual Reports for Drugs
30-Minute Update Audio CD. SOP on SOPs: Increase Your FDA Knowledge In 30 Minutes
-Presented by Dr. Joshua Sharlin - June 12, 2008.
Topics of the Model SOPs Provided:
- Four factors that influence SOP content
- Five methods for testing SOP learning objectives
- Seven required processes for a compliant SOP infrastructure
- Techniques to make your SOPs more flexible so they require less frequent updating
Adverse Event Reporting SOPs for Drugs & Biologics
-Presented by Dr. Joshua Sharlin - May 8, 2008.
Topics of the Model SOPs Provided:
- IND safety reports
- IND annual reports
- Responsibilities for postmarketing safety reporting
- Required content for postmarketing safety reports
- Validation of electronic AE systems
- Data monitoring committees
- Statistical analysis of AE data
- MedDRA coding of AE data
Adverse Event Reporting SOPs for Medical Devices
-Presented by Dr. Joshua Sharlin - May 6, 2008.
Topics of the Model SOPs Provided:
- Safety reporting for a pending PMA
- MDR(medical device reporting) requirements for device user facilities
- MDR requirements for device importers
- MDR requirements for device manufacturers
- Medical device complaint records
- Validation of AE data capture systems
- Data monitoring committees
- Statistical analysis of AE data
- MedDRA coding of AE data
SOPs for Implementing a Risk-Based Approach to FDA Part 11 Compliance
-Presented by Dr. Joshua Sharlin - October 10, 2007.
Topics of the Model SOPs Provided:
- SOP #1, Risk assessment: overview and approach
- SOP #2, Risk assessment checklist use
- SOP #3, Risk assessment: Part 11 applicability
Understanding FDA's Updated Package Insert Requirements for Drugs & Biologics: An Overview, Suggested SOPs & Implementation.
-Presented by Dr. Joshua Sharlin - March 27, 2007.
Topics of the Model SOPs Provided:
- Determining When A Label Must Meet the 2006 Format (6 pages)
- Format and Organization Requirements for the 2006 Label (12 pages)
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.
Topics of the Model SOPs Provided:
- Initial installation of SAS IQ/OQ tools (4 pages)
- Using the SAS IQ tool (4 pages)
- Using the SAS OQ tool (4 pages)