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Training Day 1

Quality By Design

09:00 AM Quality By Design and Enhancede Process Development Testing

This training course will focus on the ICH guidance’s related to principally to biopharmaceutical product development (though the principles are applicable to all pharma products). The course will cover the principles of enhanced pharmaceutical development and its linkage to the Quality by Design (QbD) approach.
Process Characterisation methodologies and expectations as well as the use of scale down process models will be covered. Later in the day the focus will be on the practical implementation of the QbD approaches in the development of Process Control Strategies, linked to Process
Performance Qualification and ultimately Continuous Process Verification. The regulatory expectations and experiences to date will also be discussed.
Course Learning Objectives:
  • Greater understanding of the ICH Q8,9,10 and 11 guidances
  • Greater understanding of QbD approaches with practical orientation
  • Use of QbD approached for Process Control Strategy development
  • Consideration for Process Performance qualification and Continuous Process Verification
  • Understanding the Regulatory agency expectations

Stability

09:00 AM Stability Testing Course

This one-day training course will cover the basic principles of chemical and physico-chemical degradation of active substances and pharmaceutical products as well as the regulatory requirements to establish a retest period or shelf-life. The course will provide practical advice for quality, chemist and pharmacist professionals in the pharmaceutical industry as well as in regulatory authorities.

Attend this Training Course to Learn:
  • The impact of thermal energy and humidity on degradation
  • What stability data is required to gain regulatory approval
  • How to design a smart stability programme for global markets
  • How to predict a shelf-life based on short term stability data
  • What kind of stability data is required to support shipment and storage