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Critical Factors for Sterile Product Manufacturing (Barnard Castle, UK)

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Course Dates

Critical Factors for Sterile Product Manufacturing (Barnard Castle, UK)

Start Date - TBD
End Date - TBC

Location: Barnard Castle, UK

Course Price TBC
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Critical Factors for Sterile Product Manufacturing

We have produced an overview of the course information available online, available here in a handy PDF Prospectus.
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Course Terms & Conditions

About the Critical Factors course for Sterile Product Manufacturing in Pharmaceutical Industry

New Sterile Product Manufacturing in Pharmaceutical Industry course topics include: RABS & Isolator Technology, Sterilisation Methods, Aseptic Processing & Process Simulation, HVAC, HACCP Principles, Cold Chain Transport, Risk Management Workshops.

The manufacture of sterile products is subject to additional GMP controls and relies heavily on the competency and knowledge of everyone involved in the process. This course covers all key aspects of sterile product manufacture, for both aseptically prepared and terminally sterilised products.

Open discussion sessions on current best practices and regulatory trends in sterile product manufacture will be coupled with case studies to illustrate key points.

Sterile Product Manufacturing in Pharmaceutical Industry

To view our full range of training courses please download the Honeyman Training Prospectus. Book your place now or enquire about our other Pharma Courses – Honeyman Training.

For practical assistance with outsourced monitoring for contamination control in pharmaceutical manufacturing visit www.honeymanlaboratories.com

Who Should Attend This Course?

Whether involved in Production, QA, QC, Engineering or Regulatory Affairs, this course will be relevant to you.

Course Features

This course covers all key aspects of sterile product manufacture, for both aseptically prepared and terminally sterilised products.

Sterile Product Manufacturing in Pharmaceutical Industry Training Course Objectives

Key learning objectives are:-

To review the key activities and processes which are critical to the success of sterile manufacturing operations
To refresh delegates on the special nature of sterile products and understand the challenges involved in aseptic processing and the consequences of failure.
To develop risk assessment methods and quantify risk
To apply risk management techniques to control contamination in clean rooms
Understand how the key aspects of the facility design, personnel, material flows, aseptic behaviors determine the success of aseptic processing.
How to implement and perform a successful aseptic validation program including practical trail design
To understand the current sterilisation & sanitisation processes and controls
To understand the importance of critical utilities in sterile product manufacture including steam and high purity water.
To understand the role of QC laboratories in sterile processes
To understand the role of the QP in sterile manufacture
To review the current regulatory requirements and trends in sterile manufacture
To understand common GMP deficiencies and what inspectors are looking for

Course Content

Review of international regulatory guidelines related to sterile product manufacture
Review of current deficiencies in sterile product manufacture
Basic microbiology and sources of contamination
Review of critical control points for bio burden control in a typical aseptic process
Sterilisation steps including terminal sterilisation
Sterilisation processes for irradiation of components
Classification and functionality of clean rooms and cleanroom design principles
Challenges in aseptic manufacture
Risk management of contamination in cleanrooms
Risk assessment method, quantification of risk and management
Garment gowning procedures and garment management
Cleanroom behaviour, personnel movements, disinfection procedures
Regulatory expectations for aseptic validation
Designing, performing media fills and interpreting results
Key aspects of quality critical utilities, including design, testing and operation
Filtration types and theory, filter selection and integrity testing
Auditing pharmaceutical QC laboratories
Understanding the role and responsibilities of the QP
Effective CAPA systems in sterile product manufacture
Sterile product inspection techniques including manual, automated and regulatory trends