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FDAnews Announces — Statistical Concepts of Process Validation Webinar, May 30, 2019
Date:5/15/2019

Statistical Concepts of Process Validation

**An FDAnews Webinar**

Thursday, May 30, 2019, 1:30 p.m. - 3:00 p.m. EDT
https://www.fdanews.com/statisticalconceptsprocessvalidation

Devicemakers: Are the organizations process validation processes leading to easy manufacturing?
If the answer is no … or even maybe … Dan O’Leary is here to help. Dan is FDAnews’s go-to guy on things technical involving medical devices. In a mere 90 minutes, he’ll help attendees decode the mysteries of 21 CFR §820.75 and ISO 13485:2016. Here’s what he’ll cover:

  • QSR requirements for process validation
  • The FDA’s approach — as documented in warning letters
  • ISO 13485:2016 requirements for process validation
  • Linking process input and process output: The statistical model
  • Linking sampling verification to the process model
  • Role of process capability and desired values of indices
  • Designed experiments: Role in determining input parameter space
  • Challenge points: Role in operational qualification
  • Risk management: Process validation’s role

Understand how available statistical concepts can lead to a successful, easy and unquestionable validation. Slapdash procedures invite warning letters. Why risk one? Spend 90 minutes brushing up the methods used in this vital area. Click here for more information about the speaker, pricing, and more.

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:
Statistical Concepts of Process Validation
**An FDAnews Webinar**
Thursday, May 30, 2019, 1:30 p.m. - 3:00 p.m. EDT
https://www.fdanews.com/statisticalconceptsprocessvalidation

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/statisticalconceptsprocessvalidation
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.

Read the full story at https://www.prweb.com/releases/fdanews_announces_statistical_concepts_of_process_validation_webinar_may_30_2019/prweb16312404.htm.


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