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FDA Warning Letters

Saturday -June 27, 05.00 pm IST

FDA Warning Letters

About the Educational Session 


"What is a US FDA Warning Letter?  It is neither a beginning nor an end, but it is a step in a site's regulatory process.  (In some cases, it spreads more widely, across enterprise .) This webinar will move through the process leading up to and from a Warning Letter.  (It will also, hopefully, lead to the demise of the phrase "a 483 letter" in the Indian press.)  A warning  characteristics that letter has certain characteristics that need to be understood.  It should be followed by explanations, negotiations and remediation.  Such efforts should have followed the receipt of the "Inspectional Observaton" by the inspected site but those efforts are not always successful.  Based on publicly available documents, the changes that can take place before and after several Warning letters will be reviewed and discussed. It will also look at ways in which the US FDA has made use of the letters as a tool to shape the industry, rather than simply address issues at a given site."  

John English, HCCP has over twenty-five years of experience in regulated computer systems including system review, design audits, field validation and significant experience in consent decree remediation.  He is considered an Expert in 21 Part 11, Data Integrity, Cloud and Virtualization issues.  Projects have included design and execution of programs to ensure the reliability of computer-related systems used in support of pharmaceutical, biologics, medical device manufacturing and ‘software as device’, including Automated Process Control, SCADA, LIMS, BAS, DCS, IT Infrastructure and higher-level systems such as adverse events, document and data management / archiving.  

Mr English served on FDA-PDA Task Force for Electronic Data Integrity (successor to the GERM group) and was a working member of the GAMP Forum, Global Information System SIG.  Currently he is a member of the GAMP SIG - Software Automation & Artificial Intelligence.  He was also a participant in the seminal Data Integrity Workshop  at ISPE/ FDA /PQRI 2016 Quality Manufacturing Conference.  While actively executing field assignments for decades, he also lectured regularly in the US, Europe, Puerto Rico and Canada on 21 CFR Part 11, "Computer Validation" & regulatory compliance issues. 

He holds Masters degrees from the University of Connecticut (Storrs, CT) and Seton Hall University (South Orange, NJ), as well as the HCCP (Healthcare Compliance Certified Professional) designation from the Seton Hall School of Law (Newark, NJ).certification Member,  John is a current member of ISPE, RAPS, ISACA, and the ASQ.