April 2018 (week of 4/23/18) three cGMP warning letters were posted by FDA. The most interesting warning letter was to a Chinese API manufacturer for an inspection from October 2017 and provides some interesting lessons learned. This API manufacturer promised FDA to improve controls over laboratory computerized systems to prevent unauthorized access or changes to data (data integrity) […]
A review of FDA citations for 21 CFR 211.42 Subpart C Buildings and Facilities over the past 5 years (2018-2014) from the FDA Turbo data was conducted by Performance Validation. Our analysis identified that the highest frequency of citations within the buildings and facilities subpart were consistently attributed to two code sections: The citations to these two sections are […]
Vice President of Services Products -
Brad has over 20 years of experience managing and executing CQV projects for the pharmaceutical and medical device industries. He has extensive experience in dry products, parenteral, facilities and utilities, and in-vitro diagnostics.
Vice President of Services Delivery -
With over 20 years of industry experience, John has been fortunate enough to experience all levels at PV and has provided services to the pharmaceutical and medical device manufacturing industries. He has extensive experience in dry products, parenteral, facilities and utilities, API, and computer systems.
Skip to main content
