Quality Management in Sterile Manufacturing

4.1 455 students

Quality Management in Sterile Manufacturing

Three days of training on sterility assurance challenges in the pharmaceutical industry and hospital pharmacies.

4.1 455 students

for pharma & biotech

Languages:

3 days in total

€ 2280.00
excl. VAT

Registration ends in 61 days

Register now

This training's start date is guaranteed

What will you learn?

A thorough understanding of the design and control factors related to the sterility assurance of sterile pharmaceutical products

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

Training description

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, 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.

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 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.

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 other)
    • 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

More Information


Date               11-13 October 2022
Location         Hotel van der Valk, Breukelen
Preparation    Yes, 0-3 hours depending on prior knowledge
Exam              Yes, optional (re-exam possible)

Discount when following all four modules: 20%
Master and PhD students receive a discount of 25%
Prices exclude exam fees

In the event of cancellation, we refer to the general terms and conditions of PCS (www.pcs-nl.com).

Course leader


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.

Training contents

19 lectures 3 days in total

Subject to changes. 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.

Training dates

Training Price From Register
Quality Management in Sterile Manufacturing
€ 2280.00 11-10-2022 Register now

Languages

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.

4.0 1977 € 7650.00
3.7 343 € 2280.00
4.1 455 € 2280.00
Quality Management in Sterile Manufacturing thumbnail
€ 2280.00
excl. VAT

Registration ends in 61 days

Register now

This training's start date is guaranteed

This training includes:

19 lectures

Lunch buffet

Training certificate

Copy of all course materials

Training 5 people or more?

In-house training may be your best choice! We have more than 100 GxP training courses on demand.