Quality Management in Sterile Manufacturing

4 rating based on 455 ratings. 455 students

Quality Management in Sterile Manufacturing

Training on sterility assurance challenges in the pharmaceutical industry and hospital pharmacies. Including new Annex 1 and Contamination Control.

4 rating based on 455 ratings. 455 students

GMP & GDP training for pharma & biotech

Language(s):

3 days in total

€ 2.590 ex. VAT

Registration ends in 38 days.

Register Now Download Brochure

The upcoming start date of this training is guaranteed.

What you'll learn

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

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, 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
Course content

Program - Day 1
Program - Day 2
Program - Day 3
LectureDay
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
LectureDay
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
LectureDay
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

Course dates

Start dateEnd dateVenuePriceStatus
31-10-202302-11-2023Van der Valk Vianen€ 2.590 ex. VATRegister
05-11-202407-11-2024Van der Valk Breukelen€ 2.590 ex. VATRegister

Language

  • Dutch secondary spoken language
    Some lectures/lessons may be in the secondary language. The primary language remains the dominant spoken/written language during the training.
  • English spoken language

General information

Learning form:Classroom
Times:The course starts at approx. 9:30 am and ends at approx. 5:30 pm
Venue(s):
Start dateVenueRegister

31-10-2023

Van der Valk Vianen

Register

05-11-2024

Van der Valk Breukelen

Register

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

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.

Quality Management in Pharma and Biotech
13 days in total
4.0 1977 € 8.550 ex. VAT
Quality Management in Manufacturing of Biopharmaceuticals
3 days in total
4.1 560 € 2.590 ex. VAT
Quality Management in Sterile Manufacturing
3 days in total
4.1 455 € 2.590 ex. VAT
Quality Management - The Role of the Qualified Person
5 days in total
4.3 617 € 3.225 ex. VAT
Quality Management in Sterile Manufacturing thumbnail
€ 2.590 ex. VAT

Registration ends in 38 days.

Register Now Download Brochure

The upcoming start date of this training is guaranteed.

This training includes:

Training certificate

Lunch buffet

Course dinner

16 Lectures

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