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The Making Medicines – Sterile Products course is mapped to the UK QP Study guide to enable delegates to understand the principles of pharmaceutical formulation and processing and the impact on product safety, quality, and efficacy.

The learning outcomes are:

• Major processing techniques for product sterilisation and the factors affecting the Critical Quality Attributes (CQA) and Critical Processing Parameters (CPP) of those techniques
• Aspects of Process Validation and control of sterile medicinal products including:
  • • Technology transfer and scale up
    • Aseptic Process Simulation (Media Fill)
• Key Elements of monitoring and control related to manufacture of sterile medicinal products, including:
  • Contamination Control Strategy
  • Facility design / maintenance / cleaning
  • Environmental monitoring
• An introduction to manufacturing of Biological and Advanced Therapy Medicinal Products (ATMP)

QPQuandary Ltd use a mixture of presentations, exercises (scenarios), and workshops to help delegates incorporate the necessary technical knowledge, leadership, and interpersonal skills, required to meet their aim of attaining the position of Qualified Person (QP).

Training is delivered by QPs and Subject Matter Experts from the Pharmaceutical Industry.

The course is interactive, with materials, assignments and assessments provided through a learning portal. Delegates must complete pre-course work, end of day exercises and post coursework.

A certificate issued on completion of the course and assignments.

Prerequisites

The course is suitable for delegates working towards the role of the Qualified Person and for existing QPs and Quality Professionals involved in manufacturing medicines, who wish to maintain continuing professional development.

Additional information

The course in delivered in person at the Maidstone Innovation Centre or online.