The sterility of a pharmaceutical product can only be assured when a series of control measures are in place. The sterility test applied to the finished product does not guarantee sterility as only a small part of the batch is tested. Participants will gain a thorough understanding of the relevant regulatory requirements, sterility assurance measures, sterility assurance concepts, which helps to develop a critical attitude towards the development and manufacture of sterile products.
Previously organized by PAO Farmacie, now by PCS Academy.
Professionals in pharmaceutical, biotechnological and medical device industries, Professionals in institutions and Contract Research Organisations (CRO’s), Hospital pharmacists and Postgraduate students.
The course is aimed at (young) professionals in non-clinical and clinical development of new medicinal products, production, packaging, Quality Control, Quality Assurance or Regulatory Affairs who are dealing with complex quality systems. The target audience needs to gain an in-depth understanding of these systems to improve quality management in their own organization. The course is an international training program in English and requires, at minimum, a Bachelor’s Degree level (HBO level in the Netherlands).
What is it about?
This module focuses on process design and control for manufacturing of sterile pharmaceuticals. The challenging environment in production requires expertise in microbiology and control systems specific for sterile manufacturing. Implementation of this expertise in the design and control of processes is crucial. Contamination factors and environmental control both influence several steps in the production process and will be discussed extensively.
Expert knowledge and real-life case studies are combined to form an ideal learning experience. Professionals from industry, academia and national regulatory authorities will share their wealth of experience and knowledge during the course.
The course is highly interactive. The program is offered as a combination of self-study, theory, and practical case studies.
After having followed this course, you will be able to:
- Apply the principles of specific sterility related subjects, such as monitoring, cleaning and disinfection, sterilization, and validation.
- Interpret the guidelines and common practices, and distinguish these facts from myths.
- Demonstrate a critical attitude towards sterility assurance in sterile manufacturing.
After having followed this course, you will have:
- A thorough understanding of the design and control factors related to the sterility assurance of sterile pharmaceutical products.
- Gained the principles of specific sterility related subjects, such as monitoring, cleaning and disinfection, sterilization, and validation
- Interpret the guidelines and common practices, and distinguish these facts from myths
- A critical attitude towards sterility assurance in sterile manufacturing
- Microbiology and implications for sterility
- Sterile manufacturing set-up
- Process and facility
- Sterilization (steam, dry heat, filtration and other)
- Cleaning and disinfection
- Cleanroom behavior
- Pharmaceutical water systems and utilities
- Environmental and water monitoring
- Sterility assurance in practice
- Validation and qualification (aseptic and analytical methods, operator qualification)
- Releasing the sterile product: The role of the QP in assuring the quality of sterile pharmaceuticals
- Real-life case studies
Go to Quality Management in Pharma and Biotech for more information about the modules.
Date 4-6 October 2021
Location Hotel Mitland, Utrecht
Discount when following all four modules: 20%
Master and PhD students receive a discount of 25%
The fee includes course notes, hotel accommodation, drinks, lunches and dinners. In the event of cancellation, we refer to the general terms and conditions of PCS (www.pcs-nl.com).
Drs. J.H.A. (Jos) Mathôt - Mathôt Pharma Support
Jos is a pharmacist by education and has over 35 years of experience working with sterile pharmaceuticals and aseptic production. Jos was operations manager at Organon, a global manufacturing organization of sterile products and site leader of a pharmaceutical isotope manufacturing organization. He has been active in CEN and ISO working groups concerning sterilization and sterility with special attention for aseptic production.
Dag 1: Programma.
Welcome and outline of the course
Biology of microorganisms - Implications for pharmaceutical production and quality control
Sterile manufacturing: a philosophy on design and control
Case study Environmental Monitoring
Pharmaceutical water systems and utilities
Dag 2: Programma.
Environmental monitoring: water monitoring
Sterilization methods: steam, dry heat
Cleaning and desinfection
Sterilization methods: Filtration and alternative methods
Case studies: Sterility Assurance in practice
Lean: application in sterility assurance
Dag 3: Programma.
Validation of aseptic processes
Validation of analytical methods
Operator Qualification, incl case studies
Workshop: the role of the QP in assuring the quality of sterile pharmaceuticals
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