Public-registration training
Quality Management in Sterile Manufacturing
Training on sterility assurance challenges in the pharmaceutical industry and hospital pharmacies. Including new Annex 1 and Contamination Control.
Quality Management in Sterile Manufacturing
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 thorough understanding of the design and control factors related to the sterility assurance of sterile pharmaceutical products
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The Training
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, and sterility assurance concepts, which helps to develop a critical attitude towards the development and manufacture of sterile products.
Including the new Annex 1!
Previously organized by PAO Farmacie, now by PCS Academy.
Target audience
Professionals in pharmaceutical and biotechnological 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 the manufacturing of sterile pharmaceuticals. The challenging environment in production requires expertise in microbiology and control systems specific to 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.
Course structure
Expert knowledge and real-life case studies are combined to form an ideal learning experience. Professionals from industry and academia will share their wealth of experience and knowledge during the course.The course is interactive. The program is offered as a combination of self-study, theory, and practical case studies.Learning goals
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
Content
- Microbiology and implications for sterility
- Sterile manufacturing set-up
- Process and facility
- Sterilization (steam, dry heat, filtration and others)
- Cleaning and disinfection
- Cleanroom behavior
- Pharmaceutical water systems and utilities
- Control
- 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
16 lectures in total. The program is subject to change. The final program will be sent to the participants approximately 1 week before the start of the training. No rights can be derived from this program.
Program - eLearning Component Lecture Sub-lectures Program - Day 1 Lecture Sub-lectures Day Welcome and outline of the course 1 Biology of microorganisms: Implications for pharmaceutical production and quality control 1 Sterile manufacturing: a philosophy on design and control 1 Environmental monitoring Case study1 Pharmaceutical water systems and utilities 1 The gowning procedure 1 Program - Day 2 Lecture Sub-lectures Day Environmental monitoring: water monitoring 2 Sterilization methods: steam, dry heat: Exercises for steam 2 Cleaning and desinfection 2 Sterilization methods: Filtration and alternative methods 2 Case studies: Sterility Assurance in practice 2 Contamination Control Strategy 2 Program - Day 3 Lecture Sub-lectures Day Validation of aseptic processes: Case studies 3 Aseptic operations in ATMP manufacture 3 Workshop: the role of the QP in assuring the quality of sterile pharmaceuticals 3 Evaluation of the course 3 Start date End date Venue Price Status 31-10-2023 02-11-2023 Van der Valk Vianen € 2.590 ex. VAT Open for registration Need training sooner?Click here to get personal training options.
Jos Mathôt
Module Leader, Senior GMP Consultant & Trainer
Jos Mathôt
To start your registration, first select the start date of the training, then fill in the form below.
Register now!
Register for this training by clicking the button.Drag the table left or right to reveal all fields.Learning form: Classroom Times: The course starts at approx. 9:30 am and ends at approx. 5:30 pm Venue(s): Start date Venue Register 31-10-2023
Preparation: Preparation required: Yes Preparation details: Homework Exam: Includes exam: Yes Exam optional: Yes Re-examination possible: Yes Exam fee in course price: No Examination fee for each exam attempt: 350
€ 2.590 ex. VAT
Training certificate
Lunch buffet
Course dinner
16 Lectures
An in-house training is your best choice! We have more than 100 GxP in-house training courses on request.
