Using Quality by Design to Improve Manufacturing - Webinar CD/Transcript

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Using Quality by Design to Improve Manufacturing: How Sponsors and CMOs Speed Production and Improve Compliance

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 presentation 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.

You will learn:

  • The risks associated with current manufacturing — there’s more than you read 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
    • Identifying the critical control parameters (CCP)
    • 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 your 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.

This course will be of 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

From the following companies:

  • Pharmaceutical companies
  • Biologics companies
  • Contract manufacturing organizations
  • Combination product manufacturers
  • OTC manufacturers

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. Among Ron's other achievements, Dr. Snee is credited with leading the design of the first company-wide continuous improvement curriculum for the global giant E.I. DuPont de Nemours. Ron has more than 25 years’ experience in his field. Ron holds a host of awards and honors, has co-authored 4 books and published more than 200 articles on process improvement, quality, management and statistics. Ron is a recipient of the American Society for Quality's (ASQ) Shewhart Medal, its highest award, and has also received ASQ's Grant Medal for his continuous contributions to quality education and research, the American Statistical Association's Deming Lecture Award, and was elected to the International Academy for Quality.