September - Warning Letter Wednesday (WLW)
Join Global Key Solutions Corp. for an engaging Warning letter on Wednesday.
Featured Speaker: John English
With 25+ years in FDA-regulated industries, John is a leading authority on Data Integrity, Part 11, and compliance strategy. He has driven major remediation programs, validated critical pharma and medtech systems, and advised on global standards through ISPE, ISACA, RAPS, and ASQ. From FDA public conferences on 21 CFR Part 11 to international workshops, John has shaped how the industry approaches data reliability, validation, and regulatory audits.
Topic: Data Forgery in FDA Warning Letters
Data Forgery risks and their impact on FDA Warning Letters
Best practices for system validation and audit readiness
How organizations can stay ahead in today’s evolving compliance landscape
Sponsor Update:
At the close, George Kwiecinski @ Global Key Solutions – will share company updates and announcements.