Higher Diploma in Biopharmaceutical & Medical Device Manufacturing

Course Outline

Lectures are delivered 2 evenings per week Online and 2 Saturdays per month on campus. Labs are held in one of our pilot facilities with times and dates subject to scheduling. (ECTS: 60 Credits) 

Course Modules Include: 

Module 1: Aseptic Processing and Utilities 

Provides the student with the skills and knowledge required for an Aseptic Manufacturing Environment.

Module 2: Regulatory Affairs and GMP 

In-depth study of the Regulatory and GMP requirements of the pharmaceutical and medical device industries.

Module 3: Medical Device Operations

Medical Device, Design and Development, Regulations, Technologies, Packaging and Sterilization.

Module 4: Biopharmaceutical Processes 

Equipment and processes of biopharmaceutical manufacture, including upstream/downstream processing.

Module 5: Pharmaceutical Process Chemistry 

In-depth study of API production, focusing on scale-up, process optimization and unit operation.

Module 6: PAT and Process Validation Statistics

Requirements for validation of GMP equipment and facilities with hands-on experience of SPC and PAT.

Module 7: QRM Principles in Pharma and Medical Device

Evaluate and implement QRM strategies, ensuring compliance within these regulations.

Module 8: Lean Operations and Deviation Investigation Methods

Includes Lean and Six Sigma, CAPA, effective report writing and preparation for regulatory inspections.

Module 9: Finished Dose Formulation and Manufacturing

In-depth understanding and hands-on experience of drug formulation, manufacturing and packaging.

Module 10: Communication Skills and Work Preparation

Communication, leadership and career development skills for success in the life science sector.