Joshua Sharlin - SOP Teleconferences
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Testing SAS Programs: SOPs and Lessons Learned
-Presented by Dr. Joshua Sharlin - February 6, 2008.
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
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
SOPs For SAS Programming: Tools For 21 CFR Part 11 Compliance
-Presented by Dr. Joshua Sharlin - September 12, 2007.
Topics of the Fifteen Model AE SOPs Provided:
- Initial SAS installation (4 pages)
- SAS validation overview (4 pages)
- SAS requirements specifications (6 pages)
- SAS high level study design
- SAS program design (6 pages)
- SAS database specification (4 pages)
- SAS directory structure (4 pages)
- SAS coding conventions (10 pages)
- SAS log review (8 pages)
- SAS change control (10 pages)
- debugging SAS logic errogs (8 pages)
- SAS testing (7 pages)
- maintaining SAS installation (4 pages)
- creating SAS transport files (3 pages)
- SAS program risk assessment (10 pages)
Adverse Reaction Reporting SOPs for Medical Devices
-Presented by Dr. Joshua Sharlin - August 30, 2007.
Topics of the Nine Model AE 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
Adverse Event Reporting SOPs for Drugs & Biologics
-Presented by Dr. Joshua Sharlin - August 23, 2007.
Topics of the 8 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
Testing SAS Programs: SOPs & Lessons Learned from Experts
-Presented by Dr. Joshua Sharlin - April 12, 2007.
Topics of the Model SOPS Provided:
- Conducting an 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
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)