Understanding and Implementing a Quality by Design (QbD) Program

Why Should You Attend:

The benefits of applying the QbD principles in the pharmaceutical industry have been well advertised. Most important are the direct benefits to our primary customer; the patient. Per Janet Woodcock M.D. Director, Center for Drug Evaluation and Research (CDER), Food and Drug Administration “All products are designed and developed to be of high quality; QbD provides a structured framework for developing, documenting and presenting development rationale, experience and knowledge of the formulation and the process, and to ensure manufacture of products consistently fit for patient use.” Application of these principles can also benefit the pharmaceutical companies by improving manufacturing efficiency and promoting innovation. However, implementing these principles into the pharmaceutical development culture can be challenging. QbD involves a complex set of interactions, technologies and systems that are not easy to grasp.

This training will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization. Topics covered will include the target product quality profile, risk assessment, methods to establish a design space, and design of a control strategy. This review will help bridge the gap between understanding the principles and practical application.

Learning Objectives

Prepare participants to better understand the principles behind using QbD to develop a pharmaceutical product:

• Understand what is meant by Quality be Design
• Understand the benefits from applying a QbD approach
• Provide key steps to implement a QbD program
• Understand what the important tools used to implement a QbD approach

Areas Covered in the Webinar:

ObD principles discussed in this training include

• Quality Target Product Profile (QTPP)
• Risk Assessment
• Using Models
• Design of Experiments
• Developing a Design Space
• Process Analytical Technology (PAT)
• FMEA and Control Plan
• Target Operational Profile
• Control Strategy

Who Will Benefit:

This course is designed for people tasked with developing, filing, and manufacturing pharmaceutical products especially small molecule oral dosage forms. This includes individuals that have responsibilities for formulation development, scale-up, filing, and commercial manufacture of dosage forms as well as maintaining the high quality of those products. Following personnel will benefit from the course:

• Senior quality managers
• Quality professionals
• Regulatory professionals
• Compliance professionals
• Production supervisors
• Manufacturing engineers
• Production engineers
• Process owners
• Quality engineers
• Quality auditors
• Development professionals
• Senior development managers

Steven Laurenz
Principal Consultant, BioPhia Consulting Inc

Steven Laurenz has over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. He is skilled in taking new products from early laboratory stage to successful manufacturing launch. He is an expert in integrating Quality by Design and risk management into product development. He has proven experience in establishing a Quality System for a R&D Quality Assurance organization.

Steven has headed product development departments at Abbott Laboratories and AbbVie Inc. and held leadership positions in numerous technical consortium.

Steven Laurenz holds an M.S. in Chemical Engineering from the Michigan State University

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