FDAnews Announces — 510(k) Change Analysis: Make the Guidance Documents Work for You Webinar, August 22, 2019

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Make FDA’s 510(k) design change guidance documents work for the organization: understand flowcharts, recordkeeping, tools for effective implementation.

WCG Market Intelligence & Insights

WCG Market Intelligence & Insights

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

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:

  • The role of risk management (ISO 14971:2007) in the evaluation process
  • The decision-making process embodied in the flowcharts
  • The criteria behind the flowchart decision boxes
  • The ways to keep quality records that support a decision

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

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDAnews
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