CAS Industrial Pharmacy – Quality Management 2022

Seize Quality Management issues and transformations head-on

The pharmaceutical industry must seize Quality Management issues and transformations head-on. But well-trained professionals are missing. To overcome this gap, the School of Pharmaceutical Sciences at the University of Geneva, in close collaboration with the Swiss Society of Industrial Pharmacists and the Groupement Romand de l'Industrie Pharmaceutique (GRIP-Pharma), as well as a diversity of experts from companies based in Western Switzerland, has launched the very first Certificate of Advanced Studies (CAS) in Industrial Pharmacy – Quality Management. Read the full article >>>

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Information

Period

January 2023 - August 2023
14 ECTS credits
105 Teaching hours
105 Distance teaching hours
210 independent study hours

Language

English

Format

Blended learning

Contact

Eric Allémann, eric.allemann(at)unige.ch, +41 (0)22 379 6148
Yogeshvar Kalia, yogi.kalia(at)unige.ch, +41 (0)22 379 3355

Location

CMU

Registration

Registration deadline

15 December 2022
Modules can be followed individually

Fees:

CAS: CHF 7'500.-
Individual module: CHF 2'000.-

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

Professional in the pharmaceutical industry (including biotechnology), as well as participant who needs to expand their knowledge in the field in order to pursue a career in a branch of quality management in industry. Holder of a Master's degree in pharmacy, biotechnology, chemistry, life sciences; holder of a Bachelor's degree (chemistry, biotechnology); holder of a Bachelor's degree or Master's degree in chemistry/biotechnology

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 projetct

Director(s)

Prof. Eric ALLÉMANN and Prof. Yogeshvar KALIA, Faculty of Sciences, University of Geneva

Coordinator(s)

Florence Von Ow-Lesniewski, University of Geneva

Partnership

Société Suisse des Pharmacien.nes d’Industrie (SSPI-GSIA) · Groupement romand des industries pharmaceutiques

Location

Geneva

Speakers

Module 1.1: Development process and main pharmaceutical forms. Prof. Eric Allémann (UNIGE), Prof. Yogeshvar Kalia (UNIGE), Dr. Alain Merkli (UNIGE and OM Pharma) Module 1.2: Operational Quality in Pharmaceutical Development. Dr. Philippe Buthier (Seagen),

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: 25
  • Independent study hours: 10
  • Distance learning hours: 25
  • Total: 60
  • ECTS: 2

Planning

Fridays: face-to-face
Saturdays: distance learning hours

Location

Geneva

Speakers

Lecturers: Module 2.1: Dr. Thomas Guebeli (Celgene/BMS), Dr. Pierre Humbert-Droz (Consultant, formerly GSK), Dr. Nathalie Wardé, Muriel Xatard (Labatec), Gilles Aebischer (Innolegal) Module 2.2: Dr. Thomas Guebeli, Dr. Florian Gurtler (BMS), Bertrand Hija

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

Planning

Fridays: face-to-face
Saturdays: distance learning hours

Location

Geneva

Speakers

A. Charpy (OM Pharma), S. Carel (Selen Pharma Consulting), F. Levrat- L. Zuchuat (Corden Pharma), Y. Berlot-Schmitt - B. Baute (Merck), F. X. Abellan - S.Lafifi (Ferring), R. Millard (Patek), S. Guerrier - S. Rudaz (UNIGE)

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

Planning

Fridays: face-to-face
Saturdays: distance learning hours

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
  • Distance learning hours: none
  • Total: 120
  • ECTS: 4

Planning

Could be completed during the CAS and/or at the end of the theoretical period of the CAS.

Diploma awarded

Participants who pass the assessment requirements and successfully complete all modules and the individual project will be awarded a CAS in Industrial Pharmacy – Quality Management by the Faculty of Sciences of the University of Geneva.
Quality management is essential for any industrial activity. The objective of this CAS is to provide high-level training in effective quality management that addresses the specific needs of the pharmaceutical, biotech and medical device industries.

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)

Steering committee

  • Prof. Eric Allémann, School of Pharmaceutical Sciences, Faculty of Sciences, University of Geneva
  • Prof. Yogeshvar Kalia, School of Pharmaceutical Sciences, Faculty of Sciences, University of Geneva
  • Dr. Gaëlle Vacher, School of Pharmaceutical Sciences, Faculty of Sciences, University of Geneva
  • Philippe Buthier, Seagen, Technical Product Steward - Manufacturing Science and Technology
  • Frédéric Zwahlen, Vifor (International) ltd, Head of Technical Operations - Senior Vice President

Number of participants

15 participants

Schedule

9:15 - 17:00 with a lunchbreak and breaks in the morning and afternoon

Professors and staff at University of Geneva and experts from the pharmaceutical industry, including executives from pharmaceutical companies located in French-speaking Switzerland

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