The 17th Annual FDA Inspections Summit kicked off with high energy by keynote speaker Elizabeth Miller, Pharm.D., Assistant Commissioner for Medical Products and Tobacco Operations Regulatory Affairs who presented on the FDA perspective on inspections. As the entire world emerges from the pandemic, it was reported that the ORA is holding “listening sessions” to see what practices adopted during the pandemic should be eliminated, modified, or maintained.
On the FDA inspection front, foreign inspections have doubled in FY 2022 and domestic inspections have increased by 50% over the same period. Special recognition should be given to all the FDA field inspectors that have continued inspections throughout the pandemic to ensure a safe supply of products to the US market. It was remarked that there was a significant increase in OAIs as a result of FDA’s increased inspection presence. As a learning from this situation, the Agency is collating all comments collected from its call for comments in the draft guidance “Conducting Remote Regulatory Assessments Questions and Answers” (here). Additional agency enlightenment was provided in a presentation concerning an additional guidance, “Computer Software Assurance for Production and Quality System Software”(here).
The FDA is retooling to prepare to support the global economy as it explores the practical applications of the lever known as Mutual Recognition Agreements (MRA). Increased cross-agency cooperation was highlighted and an example of a unique hybrid model was discussed with one agency present in person performing an inspection whilst potential other agencies attended virtually….an extremely unique situation!!!
Comments from the participants indicated themes of the return to “normalcy”. Many of the participants noted themes in issues in logistics, corrective work maintenance, and waste management, which in past years, have been relatively invisible. (see previous Lachman’s predictions on this in its blog (here).
Highlighting the conference was Lachman’s own Pat Day who introduced attendees to key technologies of artificial intelligence and how this will change the Data Integrity paradigm. Key aspects of Natural Language Processing (NLP) and blockchain were discussed, the benefits of each covered, and how this is poised to become the next revolution of data integrity. Simple case studies were presented to inspire leaders to take the first step in modernizing how they look at data integrity. With data integrity issues appearing more frequently in FDA Warning Letters, if you or your firm are interested in exploring data integrity issues, inspectional problems, or just want to stay ahead of the wolf, please contact Pat Day at p.day@lachmanconsultants.com.
