Managing Data and Documentation for FDA Inspections

Date: Dec 20, 2023

Time: 1 PM EST

Duration: 60 Minutes

Level: Intermediate to Advanced

Group Packages: Please contact ben@complyrules.com

Description

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

Additional service: (Personalized session)

We also do various similar customized events for our clients and it is specially tailored as per the client's requirement. We arrange calls between clients and our course instructors to better understand the training requirement and accordingly a training program is designed. The course duration ranges between 90 Mins and 12 hours. Most 6 hours and 12 hours of classes are split into 2 to 3 days considering customer convenience.

We have 500+ consultants who are associated with us and each have their own specialization example GxP, GMP,GLP, 21 CFR, Computer system validation, FDA Audit & Inspection, Bioassays, Design Control, Data Integrity, FDA regulation, Clinical compliance, and almost everything that falls under Risk, Quality and Compliance arena in the Life Science industry.

If you think that your team needs some kind of boost, update or refresher in Risk management and Regulatory compliance then let me know and we can design a highly cost efficient program for you.