Workshop – Quality by Design

Is your business prepared for Australian adoption of US and EU standards mandating integration of Quality by Design (QbD) principles into your design processes?

You are invited to register for this introductory four-hour Quality by Design interactive workshop offered in Adelaide, Melbourne, Sydney and Brisbane.  The workshops will cover the key principles of Quality by Design and how they apply to MTP industries and MTP implementation considerations.

Understand the implications for your business

As part of the “Pharmaceutical Quality for the 21st Century: A Risk-Based Approach” initiative, the US FDA have implemented the concepts of QbD into its pre-market processes. The focus of QbD is that quality should be built into a product. There should be an understanding of the product and process by which it is developed and manufactured, along with knowledge of the risks involved in manufacturing the product and how best to mitigate those identified risks.

Australian GMP regulations are on the cusp of adopting standards in place in the US and EU.  This means that integrating QbD into your design process not only makes good business sense – it is now critical from a regulatory perspective.

The backbone of QbD is centered around understanding the needs of your customer (the patient) and improving reliability by controlling variabilities of your product. The concept isn’t new. Joseph M. Juran, the father of QbD, believed that most quality crises and problems were due to poor planning.

QbD incorporates modern tools to pre-emptively control product and process variation as well as integrative planning.

The QbD model consists of six steps:

1. Establish the project design targets and goals.
2. Define the market and customers.
3. Discover the market, customers, and societal needs.
4. Develop the features of the new design that will meet the needs.
5. Develop or redevelop the processes to produce the features.
6. Develop process controls to be able to transfer the new designs to operations

What you will learn

The course will discuss the concepts of QbD, how it came about and why it is important in the MTP industry. The course will cover:

• The principles of QbD and how they apply in the MTP industry
• QbD terminology and process
• How QbD fits into the product development process
• The importance and impact of adopting QbD early in the product development phase
• How QbD is viewed from the regulators and how it aligns with regulator expectations
• Potential cost savings and business benefits from QbD implementation
• Implementation considerations (costs, training, leadership commitments and behaviour/culture modifications.

This interactive workshop also includes a facilitated session where participants will discuss the importance of adopting QbD, business and compliance advantages and practical examples of QbD implementation

Date and Locations

All workshops are half-day – registrations 8:45 for 9:00am start:

Contact us if you are interested in this course.