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The Making Medicines-Non-Sterile Products course reflects the requirements set out in 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 key learning outcomes are:

• development of key dosage forms (powders, capsules, tablets, inhalation, oral liquids, topical/semi-solids, transdermal patches and medicinal gases
• major processing techniques, their limitations, Critical Quality Attributes (CQA) and Critical Process Parameters
• factors that could potentially affect purity, content uniformity, stability (chemical, physical and microbiological) and bioavailability in manufacture
• relevant regulatory guidance
• principles of process validation and control
• principles of technical transfer and scale up
• quality control testing, including in-process and CQAs

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.