Introduction to Quality by Design

$349.00

Summary

Companies that have effectively incorporated quality by design into their product development efforts – from preclinical through postmarket – have seen 31% faster product development, 18% lower costs, success rates that are 3x the industry average, and a 4x return on their investment.  If you’re not achieving this level of success, this recorded seminar will help.

Learning points

  • Why the FDA has decided that quality by design is the critical path
  • Differences between quality by design-infused development programs and traditional development
  • Eleven key reasons to implement quality by design from preclinical through the postmarket
  • Why the FDA expects industry adherence to quality by design by the end of 2012
  • Five steps to immediately start fitting quality by design into your company
  • Examples of quality by design in each stage of development
  • How and why to draw attention to quality by design elements in regulatory submissions
  • Red flags that a quality by design implementation has gone off-track

And much more

Get 14+ documents for easy & quick implementation

  • SOP:  Quality by Design Principles for Medicinal Product Development
  • Sychronized audio-visual recording
  • Slides with room for your own notes
  • Customizable training certificate
  • FDA presentation on quality by design & regulatory submissions:  Moheb Nasr, Quality by Design in the New Pharmaceutical Quality Assessment System
  • FDA presentation on quality by design & regulatory submissions:  Lawrence Yu, Implementation of Quality by Design Question Based Reviews
  • FDA presentation on new drug or biologic development under quality by design:  Ajaz Hussain, Engineering a Proactive Decision System for Pharmaceutical Quality – Integrating Science of Design, Process Analytical Technology and Quality Systems
  • FDA presentation on nanotechnology and quality by design:  Nakissa Sadrieh, FDA Regulatory Considerations for Nanotechnology Products
  • FDA presentation on challenges implementing quality by design:  Helen Winkle, Implementing Quality by Design
  • FDA guidance documents on quality by design
  • ICH guidance documents on quality by design

And more

How it works

Either purchase the recorded seminar in an immediately available digital download format or request an invoice and the CD shipped to you within 10 business days.

Note: CD will be shipped after payment has been received. See our Better Business Bureau-accredited online purchasing and return policy for questions.

More benefits

  • Efficiency:  Elimination of travel means more affordable advice
  • Productivity:  Rely on technology tools to view the recorded seminar and get the reference materials
  • Veteran expertise:  Complement the seminar with a confidential teleconsulting session for further questions specific to your situation
  • Environmentally sound:  Spare our environment with less travel and a digital download

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