Course Outline
This course is delivered over 2 years. Students have the option to enter at year 1 or year 2 depending on their prior qualifications. (ECTS: 120 Credits)
Year 1
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 cGMP 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
Year 2
Module 1: Pharmaceutical Quality Management Systems
Pharmaceutical quality systems; validation; change control; investigations; audit performance; annual product reviews (APR); quality metrics; quality risk management.
Module 2: Pharmaceutical Manufacturing & Distribution
Biopharmaceutical manufacturing overview; pharmaceutical packaging; good distribution practice; product release; falsified medicines directive.
Module 3: Strategic Management
Introduction to strategic management; scanning the environment; strategy formulation; strategy implementation & change management; evaluation and control.
Module 4: Clinical Research
Drug development lifecycle; phases of clinical research; primary regulations & directives; GCP auditing/pharmacovigilance; clinical pharmacology.
Module 5: Project Planning & Finance
Project management; project initiation & conceptualisation; project scheduling and time management; project budgeting/costing; project closure & communication; project leadership & communication; risk management.
Module 6: Professional & Technical Communications
Career preparation skills; CV development; Interview skills; technical communications.