Quality by Design - An FDA initiative to Aid companies in the Development of Products and Reduce the Regulatory Burden

Instructor: Peter Calcott
Product ID: 702106
  • Duration: 90 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

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Read Frequently Asked Questions

This Quality by Design training will explain what exactly QbD is and how to implement it in your development program. It will explain FDA expectations and the return on your investment with respect to improved operations and reduced regulatory burden.

Course "Quality by Design – An FDA initiative to Aid companies in the Development of Products and Reduce the Regulatory Burden" has been pre-approved by RAPS as eligible for up to 1.5 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

QbD is a FDA driven program that has had the added benefit of building trust between the agency and industry. With the added openness and trust, the agency is reaching out to help reduce the regulatory burden on the producer with simpler submissions, reduced frequency of inspections and less complex regulatory hurdles to tackle.

In this Webinar, you will learn the origins and rationale for the QbD program, exactly what Quality by Design is and how it might be applied to your operations. With these investments of effort, you will learn what you must provide to the agency and the benefits you might glean from the effort. You will also appreciate why your other submissions have not met the requirements of QbD previously. These benefits work equally well for established products that are currently on the market and those that you plan to commercialize in the future.

Areas Covered in the Seminar:

  • The origins of QbD and the reasons why it was implemented?
  • What exactly is QbD?
  • What the agency is looking for?
  • How to assess your product development programs to determine what your return on investment for this program will be?
  • How to assess your product development efforts and streamline them to gain maximum benefit from the QbD initiative?
  • How to obtain regulatory relief in terms of simpler submissions and less frequent and shorter inspections?
  • What the challenges to implementation of QbD are?
  • Where the successes have been and how it is moving in the industry?

Who Will Benefit:

This webinar will provide valuable assistance to all in pharmaceutical and biotech industries who develop products for commercial uses. The employees who will benefit include:

  • Quality Assurance
  • Regulatory Affairs
  • Quality Control
  • Regulatory Compliance auditors
  • Manufacturing
  • Plant engineers
  • Supply Chain and Logistics
  • Project Managers working in the CMC arena
  • Senior managers and executives

Instructor Profile:

Peter Calcott, Ph.D. is founder and President of Calcott Consulting which serves the biotech, pharma and venture capital industry. It provides consulting services in supply chain, quality systems, clinical development, regulatory affairs, compliance and governance, enterprise e-solutions and government affairs. It also provides corporate strategy development, analysis and assessment especially due diligence evaluation.

He has held positions in industry in all these disciplines over a 30 year career. He has presented at national meetings and is active in the biotechnology community via BIO and the bay area BayBio trade associations where he has been the chairman of the BIO RAC committee and is presently a Board member of BayBio.

Topic Background:

Quality by Design (QbD) is an agency initiative that has been in existence for upwards of 8 years.  Success has been evident in the generic and drugs areas and recently in the Biologics.  This has resulted in improved science in the generics industry and more trust and openness between industry and FDA in the drug industry.  Much has been learned from the generics and drugs industries and it is now showing effects in the biologics industry. The results have been some startling reduction in regulatory burden and more streamlined, efficient operations.  The fruits of the program are beginning to bring a higher success rate in the commercial operations with its impact on cost of goods, reduced reporting requirements or at least a reduction in the level of reporting for supplements and less complex or stressful inspections.  Quality by design is codified very well in three ICH Q documents, Q8 – Pharmaceutical Development, Q9 – Quality Risk Management and Q10 – Pharmaceutical Quality Systems.  Recently Q11 has been issued and this focuses on Active Pharmaceutical Ingredients to complement Q8-10.

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