Course Outline
This course is the first year of our Honours Degree in Pharmaceutical Business Operations programme which is delivered over 2 years (ECTS: 180
Credits)
Module 1: Pharmaceutical Manufacturing
Pharmaceutical dosage forms; drug product formulation and their chemical function; pharmaceutical manufacturing processes; quality control release testing requirements; stability testing; process validation; change control
Module 2: Management & Organisational Behaviour
Organisational structure and design; organisation culture and change; management & leadership; organisational control and power; workgroups and teams in organisations
Module 3: Operations Management
Operations management; sales & operations planning; planning control and improvement; performance measurement; operational governance
Module 4: Regulatory Affairs & Validation
Regulatory requirements for pharmaceutical manufacturing; distribution and clinical trials; elements of typical cGXP quality systems; clinical trials; pharmaceutical manufacturing; pharmaceutical distribution; marketing authorisation application;
current trends in cGMP.
Module 5: Operational Excellence - Lean Sigma
Lean thinking; six sigma; project planning; process mapping; root cause analysis; creative solutions; corrective action preventative action; statistics; data visualisation; presentation skills; effective decision making
Module 6: Control Systems and Real-Time Analytics
Control and data management systems; system development lifecycle; process analytical technologies; real-time control system; critical quality attributes
Module 7: Clinical Research Co-ordination
Research & development process; clinical studies; statistical concepts in a clinical study; drug safety system; regulations & directives applicable to clinical trials; GCP inspection; clinical study reports & clinical overview
Module 8: Career Progression
Fundamentals of developing a successful CV; cover letters; presentation and communications skills; networking; interviewing skills; personal coaching & mentorship