Managing Data and Documentation for FDA Inspections

Deidre Tate

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How should you determine what the FDA has a legal right to see versus what’s discretionary for disclosure? Can the agency request video that was reviewed and referenced in investigation reports? Is your company’s data and documentation organized and ready for your next FDA inspection?
If not, your next inspection could become a scavenger hunt and quickly turn into a difficult experience. But that doesn’t have to be the case.
This webinar will help you get control of your data by using industry best practices and SOPs.
Areas Covered
•         How to create unique naming conventions to handle masses of data
•         How to prioritize data that might be requested during an inspection
•         About pinpoint searching and how to do it
•         How to develop assessments to gauge the risk of not being able to find a document
•         The “Top 10” questions to ask about your archival process
•         What to do when documents are not in the general archives
•         When emails do count as documentation
•         How to explain missing documents to investigators
•         If source data is electronic, how to provide access to the regulatory authority
•         If source data is paper that was scanned, what to do with the originals
•         Tips for dealing with more than one “original”
Who Will Benefit
•         QA/QC managers and staff
•         Document managers and staff
•         Regulatory affairs managers and staff
•         IT managers and staff
•         Lab managers and staff
•         Project coordinators
•         Principal investigators

Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

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Recorded video

Recorded video session

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Speaker: Deidre Tate,

Ms. Tate is a Project Director at Pinnacle Enterprise Group and has brought over two decades of experience in the design and execution of environmental, health, safety and regulatory compliance programs to Pinnacle. Prior to joining Pinnacle she enjoyed leadership roles at the corporate, divisional and facility levels. Specifically, Deidre has transformed underperforming safety cultures and environmental compliance programs for multinational companies within Automotive, Chemical, Oil & Gas and Pharmaceutical Manufacturing. Deidre is an experienced Process Safety Specialist and has conducted over 100 audits domestically and internationally as a lead auditor. She has also successfully implemented PSM/RMP, Responsible Care, VPP and CFATS at multiple facilities. Deidre served three consecutive appointments by the Dept. of Homeland Security to the U.S. Coast Guard Chemical Transportation Committee and two terms on the Board of Environmental Studies at Elon University. As part of the Pinnacle team, Deidre applies her EHS subject matter expertise to compliance auditing, program development and helping clients achieve ISO 14001, RC 14001 and VPP certifications. Deidre holds a B.S. from Michigan State University and has completed post graduate studies in the College of Chemical Engineering at Wayne State University.




Get in touch

(315) 632-0735,
(315) 750-4379