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Course Overview

There is intense pressure to develop innovative medicines for unmet medical need at affordable prices to patients and payers. The pharmaceutical industry is, quite rightly, highly regulated by international regulatory agencies that set standards for the safety, quality and efficacy of medicinal products. There has been a realisation that, while the costs involved in regulatory compliance have escalated in the last 30 years, quality standards have not improved proportionately. US and EU regulatory agencies, amongst others, are now expecting pharmaceutical companies to develop and manufacture pharmaceutical products within a Quality Risk Management framework. It is hoped that this new regulatory framework will increase the quality of medicinal products and conserve industry resources.

This course will review the old and new regulatory landscapes and will identify the practical steps needed to effect change. We will also examine the tools and enablers required to work in the quality risk management framework and discuss the regulatory and business benefits in so doing.

The Course will Cover in Detail

• The drivers that are changing the regulatory framework
• Key concepts of Quality by Design
• Ways in which pharmaceutical companies can respond to the change
  • 'Traditional' quality processes that will remain.
  • Those that will be abandoned
  • Ways of working in the Quality Risk Management framework
• A discussion of the business case for Quality by Design
• Meaningful process measurement for Quality by Design
  • This will include emerging proposals on analytical Quality by Design
• The Quality Risk Management Toolkit
• The concept of Design Space
• The outputs of the Quality Risk Management approach
  • Real Time Release
  • Continuous quality verification
  • Increasing product quality and regulatory flexibility

The course will consider regulatory guidance documents, e.g. ICH Q1 to Q10 and M4 and strategies that can be employed to align with them. The course will work exclusively with small molecule drug chemical entities and will not specifically address issues relating to biologics or vaccines. We will explain the principles and application of tools to Quality Risk Management operations, e.g. Lean Six Sigma and Failure Mode and Effects Analysis (FMEA), but will not present comprehensive proprietary information on their operation.

Who is it for?

The course targets experienced managers involved in the development and manufacture of active pharmaceutical ingredients and medicinal products or who design the supporting analytical methods and quality systems. The success of the Quality Risk Management system will depend heavily upon pharmaceutical scientists, technologists and supporting disciplines understanding Quality by Design and Quality Risk Management principles and knowing how to integrate their speciality into an integrated and efficient team effort. It will also benefit senior leaders in pharmaceutical R&D and manufacturing who are designing, or integrating, organisations to commercialise and supply medicinal products.

Course Level

The course is aimed at mid to senior managers involved in late-stage medicinal product development programmes, pharmaceutical company executives, team leaders and project managers. The course is also aimed at supporting service companies, e.g. CROs, CMOs, excipient suppliers, processing equipment suppliers, analytical instrument suppliers and other service providers.

What will I be able to do after participating?

• Have an improved and practical understanding of Quality Risk Management and Quality by Design and their importance to the modern pharmaceutical industry.
• Be able to develop late-stage R&D strategies that facilitate the smooth progression of products and technologies to the clinical trial and commercial manufacturing sector.
• Access and apply the tools and business processes critical to the successful filing, approval and launch of new medicinal products.
• Lead and/or manage organisational change and the development of new ways of working to align with regulatory agency systems management expectations.