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This Special Purpose Award in Validation Science provides an accredited level 7 qualification in Validation Science over one year for individuals who are seeking to up-skill or crossskill in order to gain suitable employment in sectors suc...

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This Special Purpose Award in Validation Science provides an accredited level 7 qualification in Validation Science over one year for individuals who are seeking to up-skill or crossskill in order to gain suitable employment in sectors such as biopharmaceutical, pharmaceutical and medical device industries.

This programme has been developed in response to the requests from the industrial participants in the South Western Skills Forum.

The programme targets employment roles in production/ manufacturing, quality assurance, regulatory affairs, commissioning, qualification, validation and operation roles within pharmaceutical/biotechnology/medical device manufacturing companies.

Students gain valuable knowledge and key skills in subject areas pertinent to working in highly regulated manufacturing environments such as GMP, QA, QC and Validation.

Students will attain a knowledge and understanding of the principles of quality regulation as required by the principles of current Good Manufacturing Practice. The importance of validation of equipment, plant, utilities, processes and procedures in industry will be shown to be an essential approach to consistently producing products of the intended quality. The student will gain an understanding of the increasing regulatory requirements relevant to the biomedical, pharmaceutical and biopharmaceutical industry. The proposed modules are focused not only on the biotechnological industries but also find applications into other regulatory compliant environments such as the pharmaceutical and medical technology sectors.

The programme uses a mixture of online multiple choice question assessments and online submission of assignments. The first introductory module is a blended module and will consist of a mixture of online teaching, lectures and workshops. Several industry champions will deliver workshops and webinars that will reinforce the fundamental content delivered by the academic lecture team. Industry generated case studies focusing on different aspects linked to different learning outcomes, online lectures/seminars, Industry Guest Lecturers for webinars.

The second module gives the student a broad understanding of the application of current Good Manufacturing Practices to the validation of equipment, plant, utilities, processes and procedures in the pharmaceutical and medical device industries. The principles of risk assessment techniques in validation are applied.