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).
If you're a pharmacist or hospital pharmacist interested in earning accreditation points by attending this training,
New Accreditation Request
Read the disclaimer and complete the form below.
Disclaimer
Please note that PCS will only submit an accreditation request to the relevant accreditation institutes if three or more pharmacists or hospital pharmacists have registered, submitted an accreditation request, or have a pending reservation for a training session.
Requesting accreditation is costly for PCS, both in time and money, with costs per request ranging between four and five hundred euros. We aim to avoid making such requests without sufficient reason. Therefore, we kindly ask you to carefully consider before requesting accreditation.
Accreditation is evaluated by the NVZA and KNMP based on multiple factors, and it is not clear in advance how many accreditation points will be granted. No rights can be derived from your accreditation request as a participant. There is a possibility that no accreditation will be granted at all.
PCS reserves the right not to submit an accreditation request for any reason, which may not be disclosed to the participant. PCS's decision in this regard is final. PCS is not liable for any losses or damages resulting from the failure to obtain accreditation. We reserve the right to change our accreditation policy at any time without prior notice.
Criteria
Only pharmacists and hospital pharmacists may request accreditation.
Deadline
Accreditation requests will only be processed if made more than four weeks before the start date of the training.
(University) Students
Master students get a discount of 25% per module/training.
Results
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
Contents
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
Program
Lecture
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 study
1
Pharmaceutical water systems and utilities
1
The gowning procedure
1
Lecture
Day
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
Lecture
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
Quality Course modules
This module is part of a series called: "Quality Management in Pharma and Biotech". This series is designed to give participants an in-depth understanding of the QP’s role and responsibilities. See the other modules in this series below.
Group discounts are only applicable when multiple participants register for the same course at the same time.
Language (upcoming edition):
English spoken language (primary)
Dutch spoken language (secondary)
Some lectures/lessons may be in the secondary language. The primary language remains the dominant spoken/written language during the training.
Learning form:
Classroom
Times:
Starts at approx. 09:00 and ends at approx. 17:30
Requires preparation:
Yes.
This module contains homework. The homework will be provided prior to the training.
Includes exam:
Yes.
Exam price:
€350.00 ex. VAT per participant.
Notes to the course dinner:
The course dinner takes place on day 2.
Lecturers
Wilma Meijs
Trainer
Experienced consultant and director with over 25 years of expertise in the pharmaceutical industry, focusing on GMP...
Trainer Profile
Wilma Meijs
Biography
Experienced consultant and director with over 25 years of expertise in the pharmaceutical industry, focusing on GMP (Good Manufacturing Practice) and quality management systems. Wilma Meijs has been the owner of Wilma Meijs Farmaceutisch Advies BV since 2011, where she provides consultancy services in GxP for pharmaceutical companies.
Expertise and Services:
Project Leadership in validation of processes and equipment.
Qualified Person (QP) responsible for product release.
QA Support for the development of new pharmaceutical products and production processes.
Implementation of Quality Systems, including Trackwise.
Conducting Internal and External Audits.
Developing and Delivering Training Courses for pharmaceutical staff.
Facilitating Risk Assessments and setting up environmental monitoring programs.
Validation Support for production processes, cleaning validation, equipment qualification, and QC test implementation.
Previous Positions:
QA/QP at Intravacc (2012-2015): Responsible for quality assurance and acting as Qualified Person.
QA/QP at Abbott Biologicals (2007-2012): QA for the influenza development group, handling product complaints, and QP responsibilities.
Consultant and Director at PCS (2004-2011): Various QA/QC positions for different pharmaceutical companies, including QP functionality and developing training programs.
QA at Nederlands Vaccin Instituut (2005-2011): Support of the QA department, GMP improvement projects, and project manager for the implementation of QMS/DMS (Trackwise).
QA/QC Manager at AMT Biopharma (2003-2004): Setting up and implementing quality systems for viral-based pharmaceuticals.
QC Manager at Merck Sharp & Dohme (2000-2003): Daily management of the QC laboratory, responsible for analytical and microbiological analyses and environmental monitoring.
QC Manager at Teva Europe (1995-1999): Managing routine QC analyses, technical transfers of QC tests, and setting up a laboratory for cytostatics.
Education:
PhD in Radiopharmacy from VU University Amsterdam. Research focused on the development of new radiopharmaceuticals, with the thesis titled: "The suitability of Zirconium-89 for labelling of antibodies for positron emission tomography".
Joke Ederveen
Trainer
Experienced consultant with 40 years of expertise in virology, microbiology, aseptic processing, and analytical meth...
Trainer Profile
Joke Ederveen
Biography
Experienced consultant with 40 years of expertise in virology, microbiology, aseptic processing, and analytical method validation. Possesses extensive experience with various quality systems such as GMP, GLP, and ISO 17025, and is familiar with guidelines from FDA, EMA, and ICH in the development of pharmaceutical products. Holds an MBA from Nyenrode Business University, enabling the effective application of this knowledge in new laboratories and where change is needed. Experienced in all phases of pharmaceutical development, from early research and clinical phases to commercial production.
