FALLS CHURCH, Va., Aug. 8, 2019 /PRNewswire-PRWeb/ -- 510(k) Change Analysis: Make the Guidance Documents Work for You
FDA's 510(k) design change guidance documents are not the easiest to understand and incorporate into the manufacturing process. While the guidance's flowcharts were designed to help guide an evaluation and decision-making, they can instead create confusion.
Industry expert Dan O'Leary, President of Ombu Enterprises, LLC. will present critical guidance information to assist one on records and decision taking, including:
Attendees will come away with an understanding of the 510(k) decision-making process and its proper documentations to stand up to an FDA inspection.
Bonus material! Attendees will receive an Excel workbook, that implements the logic in the flowcharts, guiding one through the decision-making process and enabling one to provide enough documentation.
Develop a well-reasoned decision-making process and appropriate documentation to avoid a 483.
Interested in registering multiple sites? Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally to learn about our special multisite discount.
Webinar Details: 510(k) Change Analysis: Make the Guidance Documents Work for You An FDAnews Webinar Thursday, August 22, 2019, 1:30-3:00 p.m. EDT https://www.fdanews.com/510kchangeanalysismakeguidance
Tuition: $287 per site
Easy Ways to Register: Online: https://www.fdanews.com/510kchangeanalysismakeguidance By phone: 888-838-5578 or 703-538-7600
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