We are happy to announce that we will be exhibiting at this year’s INTERPHEX trade show in New York City May 24th – 26th.
We will have consultants available to answer any testing and compliance questions. Stop by booth # 1753 for a complimentary, personalized 30-minute consultation.
Also, mark your calendar to attend our educational lecture that is part of the Technical Conference. See the details below.
Date & Time:
May 25th from 1:00 p.m. to 1:30 p.m.
Topic:
A Search for Meaning: A Review of FDA Form 483 Inspectional Trends 2018-2021
Speaker:
Steven Lynn, Executive VP, Pharmaceuticals, Regulatory Compliance Associates, a Nelson Labs company
Abstract:
The US FDA conducts global inspections of pharmaceutical companies each year. If FDA investigators find objectionable conditions during the inspection, they will document these observations on a US FDA Form 483. Regulatory Compliance Associates, in conjunction with partner Redica Systems, has done an analysis of 483 observations over the past 4 years (2018-2021). Steven Lynn, who is a current consultant to the industry and has held executive roles at the FDA and within the pharmaceutical industry, will present the findings of this analysis, along with practical examples of how to address some of these industry-wide trends.
