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CM2011: Introduction to Validation

Credit Weighting: 5
No. of Students: Min 10.
Pre-requisite(s):
Co-requisite(s):
Teaching Period(s): Semester 1.
Teaching Methods: 40 x 15min(s) Lectures (Online); 4 x 3hr(s) Workshops (Industry led); 6 x 1hr(s) Other (Industry webinars); 6 x 1hr(s) Directed Study
Module Co-ordinator: Dr Eric Moore, Department of Chemistry.
Lecturer(s): Staff, Department of Chemistry, and Industry Guest Speakers.
Module Objective: This module will provide students with an introductory knowledge of validation as applied in industry. It aims to deliver a broad scope of industry relevant validation topics that will give students valuable insight and raise their awareness of the importance, implementation and impact of validation in industry.
Module Content: This module gives the learner an introduction to the concept of validation as required by the principles of current Good Manufacturing Practice and Good Laboratory Practice. The student will gain an insight of the increasing regulatory requirements relevant to the biomedical, pharmaceutical and biopharmaceutical industry. The following topics will be delivered:
路 Requirements of cGMP, QA, GMP, and Quality Control as interrelated aspects of Quality Management.
路 Quality Assurance aspects.
路 Data Integrity
路 Quality Audits.
路 Laboratory Management Systems.
路 Process Control and Product Release Strategies.
Learning Outcome: On successful completion of this module, students should be able to:
  • Describe validation and Quality Management.
  • Explain GDP and GMP in an industry context.
  • Apply Industry validation practice across several sectors.
  • Identify key principles of validation in Quality Control/Assurance.
  • Explain international standards and regulations requirements and how they are applied in a GMP environment.
  • Identify documentation required for validation including process audits.
  • Describe the processes used to manage non-conformances and improvement opportunities in a GMP environment.
Assessment: Continuous assessment: 4 x case-study based workshop assignments and 6 x online MCQ assessments.
Compulsory Elements: Continuous Assessment.
Penalties (for late submission of course/project work etc.): Work which is submitted late shall be assigned a mark of zero (or a Fail Judgement in the case of Pass/Fail modules).
Pass Standard and any Special Requirements for Passing Module: A Pass judgement.
End of Year Written Examination Profile: No Formal Written Examination.
Requirements for Supplemental Examination: No Supplemental Examination.

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