Module Learning Outcomes

At the end of the programme, participants will be able to:

• Master information provided during courses
• Understand the Pharmaceutical Industry Quality requirements and challenges
• Have an end-to-end (E2E) overview of Quality processes within the Pharmaceutical Industry
• Learn about Pharma Quality oversight by authorities and customers
• Learn about Lean and Supplier management in the frame of Quality Management
• Develop their competences in the field of Pharma Quality Management

1. Knowledge and understanding

• Have a global overview of quality requirements
• Understand regulatory affairs requirements
• Describe the role of the Qualified Person
• Understand the role of Quality Management in the pharmaceutical industry
• Understand the purposes of audits and inspections
• Understand how to manage third parties in the pharmaceutical industry
• Corrective and preventive actions (CAPA) plan

2. Making judgements

• To be able to analyse, judge and provide theoretically grounded justification to complex issues within new and unfamiliar contexts, e.g. able to identify and classified deviation on risk based analysis and prepare correctives and preventive actions

3. Communication skills

• To be able to communicate complex issues, judgements and approaches to all stakeholders in a clear and unambiguous manner
• To be able to respond to other arguments and develop, substantiate and negotiate alternative solutions.
• For example, to be able to communicate appropriate measure of correction to management

4. Learning skills

• To be familiar with their fields of expertise and their professional fields and can independently deal with, assess and integrate relevant knowledge.
• To define their learning objectives autonomously, enhance their scientific and practice-oriented competences, and transfer their knowledge to different contexts.

Teaching activities and methods:

• In-person (lectures, workshops, group work)
• Online (collaborative activities, forum, serious games...),
• Individual monitoring / tutoring

Assessment methods:

• MCQ
• case study
• presentation

Prerequisites and additional documentation:

• Reading of coursework documents and preparation for the courses is compulsory and optional additional reading material may also be suggested
• Other resources including websites, videos, and other platforms may also be used during the course

Module's workload and ECTS credits

• Teaching hours: 40
• Independent study hours: 40
• Distance learning hours: 40
• Total: 120
• ECTS: 4

Key topics / Study fields:  Quality in pharmaceutical industries: validation, controls.

The validation Master Plan (VMP)

Equipment and Utilities Qualification (DQ, IQ, OQ, PQ)

Metrology: Calibration of analytical instrument

Monitoring of manufacturing zone, utilities and personal

Process validation (incl. cleaning validation)/cross contamination

Computer System Validation CSV (GAMP model – Data Integrity)

Analytical method transfer and validation (incl. Cleaning validation method)

Microbiological tests (incl. purity, sterility, pyrogens…)

Stability ICH and follow-up Stability

Management of OOS – OOE and OOT

Problem solving (A3 – 5W – Ishikawa)

Assessment of process capability

Develop a sampling plan – measurement of yield

IPC Method (control card..)

Hygiene and Monitoring (surface – sampling – etc)

Packaging: Printed material, reconciliation, serialization & Aggregation

Lean management tools (six sigma, VSM, 5S, TPM, OEE)

Module aim / goal:

Qualification and Validation: Understand the principles of qualification and validation: from the expression of the need for new equipment to its use during the manufacture of commercial batches: what are the objectives of these test stages, what are the benefits for the company?

Quality Control & the Laboratory: Develop skills in the field of quality control, Acquire the notions of microbiology, Develop this knowledge in the validation of analytical methods. Develop the notion of data integrity

Operational Quality in Manufacturing: Elaborate a quality System to manage issues related to manufacturing activities. Master some tools like Problem solving, process capability assessment and adequate sampling plan

Module Learning Outcomes

At the end of the programme, participants will:

• To have a common theoretical basis to approach the different stages of the V-cycle _ the qualification and validation phases. Apply data integrity concepts.
• Understand the constraints of zone concepts: from design to routine.Implement environmental and microbiological monitoring.
• Become familiar with the different aspects of quality control and method validation: Understand the organisation of a quality control laboratory and participate in the validation and transfer of analytical methods
• Develop a strategy for the management of stability studies.
• Be able to implement lean and statistical methods and understand their contribution to process management.

Teaching activities and methods:

• In-person (lectures, workshops, group work)

Assessment methods:

• MCQ
• case study with oral presentation

Prerequisites and additional documentation:

• Compulsory and optional readings
• Other resources: websites, videos, platform

Module’s workload and ECTS credits

• Teaching hours: 40
• Independent study hours: 40
• Distance learning hours: 40
• Total: 120
• ECTS: 4

Key topics / Study fields:

Quality in health products industry (specific topic could vary depending on the participant's subject)

Module aim/goal:

• Enable participants to apply practically, in professional contexts (industry, university, institute,...), their theoretical Quality knowledge acquired during Module 1, 2 and 3
• Enable participants to adopt a method of analysis and use problem-solving strategies, with presentation of results to peers and expert audiences
• Enable participants to work and bring solutions to a real innovative Quality challenge

Assessment methods:

• Written report
• Defence in front of a jury (in-person if possible)

Prerequisites and additional documentation:

• Reading of coursework documents and preparation for the courses is compulsory and optional additional reading material may also be suggested
• Other resources including websites, videos, and other platforms may also be used

Module's workload and ECTS credits

• Teaching hours: none
• Independant study hours: 120
• Distance learning hours: none
• Total: 120
• ECTS: 4