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Fundamentals of Quality by Deisgn (QbD)
Implementing ICH Q8 - Quality by Design
Conducted by Gamal Amer, Ph.D.
Principal - Premier Compliance Services, Inc.
March 22, 2013
This web seminar will focus on defining what Quality by Design means based on a review of the FDA’s initiative on QbD and on a review of ICH Q8 guidance to industry. The presentation will then proceed to define requirements for implementing QbD in product and process design.
We will then outline a step-by-step systematic approach to implementing QbD in any development project. We will review the concepts of User Requirements, Ishikawa Fishbone Diagrams, FMEA (Failure Mode and Effects Analysis) principles for performing root cause analysis, the use of Experimental Design to define critical factors, conducting reviews, and the principles of knowledge, design, and control space and how to define them.
Specific topics to be covered include:
- Review of the ICH Q8 (R2) and ASTM E2500 to understand the QbD concepts from a compliance viewpoint
- Define the QbD systematic approach
- Discussion of the needs for User Requirement Specifications (URS)
- How to effectively use an Ishikawa Fishbone Diagram
- Using Root Cause Analysis techniques to identify risk factors
- Principles of Design of Experiments (DOE)
- How to use Knowledge space (Science base), Design space (DS), Normal Operating space (Range), Control space (Range), and Design Reviews to support QbD implementation
- A step-by-step QbD implementation roadmap
- Questions and answers with Dr. Gamal Amer
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All registrations include handout materials. Once you’re registered, you will receive via e-mail (the e-mail address you provide in your registration) the presentation handout materials the day before the seminar.
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|Get the MP3 file and handout
GMP130322E - MP3 audio file and handout materials
Fundamentals of Quality by Design
Gamal Amer, Ph.D.
Gamal Amer, Ph. D. is Principal at Premier Compliance Services, Inc.; Management Consultants for compliance and manufacturing operations performance in the life sciences industry. He holds a Ph. D. in Chemical Engineering and has over two decades experience in the Pharmaceutical and related industries. He has held positions of increased responsibility with leading pharmaceutical, consumer product and engineering consulting firms over the years. His experience includes comprehensive process design in bulk pharmaceutical manufacturing, biotechnology manufacturing, pharmaceutical solid dosage manufacturing and containment of potent and radioactive therapeutics. He is also experienced with facility development for therapeutic products operations.
Dr. Amer is a recognized expert in GMP compliance and validation. He has consulted for many of the leading pharmaceutical, biotechnology and medical device manufacturers. He has lectured extensively in the US, Europe, Asia and the Middle East, taught many courses, and authored many papers which were published in peer reviewed publication. He is a member of ISPE, PDA, ACS and AIChE.
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