Overview
Objectives
- To acquire detailed and thorough knowledge about Quality Management throughout the drug's life cycle
- To understand the regulatory and normative health industry contexts in which Quality Assurance is used
- To learn and master the tools of Quality Assurance
- To adopt a method of analysis and use problem-solving strategies to enable the presentation of results to different audiences
- To apply the lessons to concrete situations in the workplace through the use of case-studies
Audience
Learning outcomes
- Possess a good knowledge of Quality and its application in the pharmaceutical industry
- Master the legal framework for pharmaceutical product marketing and the relationship between the holder of the marketing authorization and operators
- Master the qualification and validation processes as well as Quality Control operations
- Able to manage an inspection and establish an appropriate CAPA (Corrective and Preventive Actions)
- Able to manage suppliers and service providers from a Quality perspective to ensure patient safet
- Able to analyse, judge and determine the quality attributes in a development project in order to develop innovative solutions at a complex level
- Able to assume executive functions in the analysis, systematization, and resolution of complex problems in new contexts, with theorybased solutions
Programme
- Development of pharmaceutical formulations
- Regulatory management and audits
- Operational quality, qualification and quality control
Individual project
Diploma awarded
Registration
Registration deadline
Fees:
CAS: CHF 7'500.-
Individual module: CHF 2'000.-
Admission criteria
- Hold a university master's degree, a university bachelor's degree, a bachelor's or master's degree from a university of Applied Pharmaceutical Sciences or a degree deemed equivalent
- Have at least some professional experience related to the Certificate programme
- Have a good command of oral and written English (B2 Level)
Number of participants
Curriculum
Period
Credits
Teaching hours
Schedule
9:00 - 17:00 with a lunchbreak and breaks in the morning and afternoon
Location
Description
Key topics / Study fields:
Module 1.1: Introduction in drug development process & main pharmaceutical formulation
- Overview of the Drug Product development process in the pharmaceutical industry (from drug substance to drug product)
- Present and explain the formulation, production and tests of oral solid dosage forms and liquid dosage forms (oral and parenteral)
Module 1.2: Operational Quality in Pharmaceutical Development
- Quality by design
- Quality risk management
- Oral solid dosage forms manufacturing processes, control strategy design.
Common technical document (CTD)
Module aim / goal:
- Module 1.1: Enable students to understand the development process of pharmaceutical forms, the technology and procedures to produce and test most of the dosage forms
- Module 1.2: Enable the students to develop a pharmaceutical product following a Quality By Design approach. Enable students to conduct a risk analysis.
Module Learning Outcomes (nqf.ch-HS)
1. Knowledge and understanding
- the process of bringing a new pharmaceutical drug to the market, from Drug Substance discovery to Drug Product manufacturing
- Understand the basics of pharmaceutical manufacturing technologies, excipients and equipment used
- Understand the organization within the pharmaceutical industry
- nderstand the working methodologies used by the pharmaceutical Industry
2. Applying knowledge and understanding
- Develop various pharmaceutical products following the Quality by Design (QbD) approach
- Determine the quality attributes and design space in a development project.
- Determine the critical process parameters related for design of experiment
3. Making judgements
- Analyse, judge and provide theoretically grounded justification for new drug development, for technology transfer project and for commercial manufacturing activities
4. Communication skills
- Communicate the applications of legal and regulatory standards of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in a clear and unambiguous manner
- Respond to arguments as well as develop, justify and negotiate alternative solutions with different groups of interlocutors
- Be prepared for questions of health authorities during preapproval inspections or GMP regular inspections.
5. Learning skills
- Know how to autonomously acquire relevant knowledge regarding drug development and drug formulation and industrial process
- Know how to autonomously acquire relevant knowledge regarding Quality management in health industries, evaluate and integrate them
- Be able to find reliable information about the pharmaceutical regulations and the regulatory updates relating to the development of health products and be able to apply them
Teaching activities and methods:
- In-person (lectures, workshop, group work)
- Collaborative activities (forum, case study)
- Other: on-site visit
- Flipped classroom
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: 50
- Independent study hours: 10
- Total: 60
- ECTS: 2
Speakers
Location
Description
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: 80
- Independent study hours: 40
- Total: 120
- ECTS: 4
Speakers
Location
Description
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: 80
- Independent study hours: 40
- Total: 120
- ECTS: 4
Speakers
Description
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
- Total: 120
- ECTS: 4
Intervenant-es
Professors and staff at University of Geneva and experts from the pharmaceutical industry, including executives from pharmaceutical companies located in French-speaking Switzerland
Partnerships / Collaboration
Partnership
Director(s)
Prof. Yogeshvar KALIA, Faculty of Sciences, University of Geneva
Coordinator(s)
Steering committee
- Prof. Yogeshvar Kalia, School of Pharmaceutical Sciences, Faculty of Sciences, University of Geneva
- Prof. Gerrit Borchard, School of Pharmaceutical Sciences, Faculty of Sciences, University of Geneva
- Dr. Magali Zeisser-Labouebe, School of Pharmaceutical Sciences, Faculty of Sciences, University of Geneva
- David Limal, OM Pharma, Head of Quality Management
- Nathalie Wardé, D4P-pharma, General Manager & Founder
Contribution to the Sustainable Development Goals
