FDAnews Announces — Using Quality by Design to Improve Manufacturing: How Sponsors and CMOs Speed Production and Improve Compliance Webinar, May 7, 2015

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FDA is promoting the use of Quality-by-Design (QbD) as an approach for helping pharmaceutical and biotech companies speed up production, fine-tune continuous manufacturing and improve quality. This webinar will present a holistic approach to QbD with a focus on how the needed process understanding is developed to enable effective process development, quality improvement and maintain compliant operations.

Using Quality by Design to Improve Manufacturing:
How Sponsors and CMOs Speed Production and Improve Compliance
**FDAnews Webinar**
May 7, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/qualitybydesign

The life sciences industries are going through enormous financial changes that are forcing them to do more with less. Mergers, acquisitions, the patent cliff and more are forcing sponsors and CMOs to finds ways to speed up production while still maintaining quality and compliance.

FDA is promoting the use of Quality-by-Design (QbD) as an approach for helping pharmaceutical and biotech companies speed up production, fine-tune continuous manufacturing and improve quality.
QbD is a disciplined and systematic approach for effectively creating and communicating the processes and systems needed to build quality into the product at every stage of production.

This webinar will present a holistic approach to QbD with a focus on how the needed process understanding is developed to enable effective process development, quality improvement and maintain compliant operations.

Attendees will learn:

  •     The risks associated with current manufacturing — there’s more than what’s in the papers
  •     QbD — what and why the FDA is focusing on it — and how they expect firms to deploy it while maintaining compliance
  •     How QbD benefits both sponsors and their CMOs
  •     Best practices for understanding and reducing risk
  •     Experimental strategies for process design

o    Identifying the critical control parameters (CCP)
o    Right data in the right amount at the right time

  •     Proven techniques for developing a QbD monitoring system for process performance and product quality
  •     How to use QbD to enable successful tech transfer — poor tech transfer has doomed many manufacturing executive’s careers
  •     When and how to revise SOPs, training programs and general culture to effectively deploy QbD in an organization
  •     Years of tips to success and traps to avoid in the effective implementation of QbD

The concepts and methods involved will be introduced and illustrated with pharmaceutical case studies and examples. Commonly held misconceptions will be addressed and a holistic approach to QbD will be presented.

Meet the Presenter:
Dr. Ron Snee, Founder and President of Snee Associates, has an outstanding record of leadership in process and organizational improvement in a variety of industries including: pharmaceutical, biotech, clinical diagnostics, chemical, plastics, telecommunications, financial services, newspapers and insurance. Ron is credited with leading the design of the first company-wide continuous improvement curriculum for the global giant E.I. DuPont de Nemours.

Who Will Benefit:

  •     Manufacturing and operations executives
  •     QA/QC personnel
  •     Process validation and productivity experts
  •     Compliance personnel
  •     Product lifecycle management executives
  •     Regulatory affairs professionals
  •     SOP development and training executives

Conference Details:
Using Quality by Design to Improve Manufacturing:
How Sponsors and CMOs Speed Production and Improve Compliance
**FDAnews Webinar**
May 7, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/qualitybydesign

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/qualitybydesign
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
+1 (703) 538-7665
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