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Overview of Quality by Design
This seminar presents the basics of Quality by Design in such a way as to allow attendees to understand Quality by Design as it applies to their company and their products.
Description
Six years after the announcement of the FDA’s cGMP Initiative for the 21st Century, the FDA has finally coalesced on an approach it calls “Quality by Design.” Despite numerous presentations by FDA officials, several pilot programs and the adoption of Quality by Design by the International Conference on Harmonization (ICH), confusion about Quality by Design reigns throughout the pharmaceutical, biotechnology and medical device industries.
Drawing upon FDA insights, client case studies and industry experiences, this seminar presents the basics of Quality by Design in such a way as to allow attendees to understand Quality by Design as it applies to their company and their products.
Areas Covered in the seminar:
- What is the FDA’s Quality by Design initiative?
- Why is the FDA pushing Quality by Design?
- Comparison of traditional model (from concept to post-market) to new Quality by Design model.
- Outlook for Quality by Design in the FDA, EU and IC.
- Benefits of Quality by Design.
- Success factors in adopting Quality by Design.
What will Attendee Learn:
- Firm understanding of FDA, EU and ICH expectations.
- Overview of current and emerging Quality by Design strategies.
- Be able to develop a business case (including estimated return on investment) for Quality by Design adoption.
- Understand the background and nature of best practices for Quality by Design.
Who will benefit:
- VPs, directors and senior managers of pharmaceutical, biotechnology and medical device companies
- Small to midsized company C-level executives
- Biotechnology startup management teams
- Executives in research and development (R&D), preclinical, manufacturing, regulatory affairs, and quality management
- Venture capitalists looking to speed the time to market of their funded clients
Instructor Profile:
John Avellanet, is a leading international authority on lean compliance and quality by design. He is the publisher of the monthly SMARTERCOMPLIANCE™ executive newsletter, coauthor of the book, Best Practices for Biotechnology Business Development, and a frequent speaker and radio guest. As a result of his work, Mr. Avellanet’s clients have seen faster times to market, higher product development success rates and better financial results.
For more than 15 years, he served as an executive accountable for regulatory compliance, information technology and records management, most recently as a C-level executive for a Fortune 50 biotechnology and medical device subsidiary. In 2006, he co-founded his private consulting firm, Cerulean Associates LLC (www.ceruleanllc.com).
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