Pharmaceutical Sterilisation Principles in Practice®
Course
In Barnard Castle
Description
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Type
Intensive workshop
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Level
Intermediate
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Location
Barnard castle
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Class hours
24h
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Duration
3 Days
A highly practical course based on our knowledge within the industry and current projects which includes case studies and workshops to allow our delegates to put the principles into practice.
According to the EU GMP Guide Annex 1, the manufacture of sterile products is subject to special requirements in order to minimise the risks of contamination, with much depending on the skill, training and attitudes of the personnel involved. In particular, managing sterilisation processes is critical to the manufacture of both terminally sterilised and aseptically prepared products.
The Pharmaceutical Sterilisation Training: Principles in Practice® course provides delegates with a comprehensive understanding of moist heat and dry heat sterilisation processes from theoretical foundation through to the practical aspects of validation and biological indicators. The course highlights the GMP requirements and current industry expectations for the routine operation, monitoring and control of sterilisation processes and gives practical examples of how these techniques are applied through appropriate engineering to ensure reliability in full compliance with all European and US regulatory requirements.
Important information
Documents
- Sterilisation Principles in Practice V2.A4.pdf
Facilities
Location
Start date
Start date
About this course
Key learning objectives of the course are:
- To facilitate delegates to make risk based decisions based on science through increased understanding of sterilisation technology
- To improve regulatory compliance and increase awareness of industry best practice.
- To Increase process capacity
- To reduce re-qualification effort and ongoing costs
Engineers, Microbiologists, Technical, QA and QC personnel as well as Production and Operational personnel.
UPDATED CONTENT includes changes to Chapters 5.1.1 and 5.1.2 concerning sterilisation and biological indicators that have been significantly revised with the implementation of Revision 9.2 Ph.Eur in July 2017.
Reviews
Subjects
- Compliance
- Sterilisation Standards
- Moist Heat Sterilisation
- Steam Quality
- Dry Heat Sterilisation
- Depyrogenation
- Instrumentation
- Control Processes
- Biological Indicators
- Pharmaceutical Sterilisation
- Training
- Training Pharmaceutical
- Pharmaceutical manufacturing
- Pharmaceutical Management
- Terminally Sterilised Products
- Aseptically Prepared Products
Teachers and trainers (1)
Marcus Booth
Director of Training and Consultancy
Over the last 27 years we have trained thousands of people within the pharmaceutical, biotech, medical device and health care industries. Honeyman courses continue to remain popular because they provide delegates with a sound understanding of the scientific principles associated with each technical discipline and the opportunity to put the principles into practice during interactive workshops, demonstrations and discussion sessions. We all actively work within industry and so provide pragmatic current best practice to allow companies to cGMP requirements and regulatory expectations.
Course programme
- Development of Current Sterilisation standards
- Principles of Moist Heat Sterilisation
- Steam Quality Generation Distribution and use
- Dry Heat Sterilisation and Depyrogenation
- Instrumentation and Control of Sterilisation Processes
- Steam In Place
- Quality Systems Associated with Sterilisation Processes
- Auditing Sterilisation Processes and Preparing for a Regulatory Inspection
- Biological Indicators
- Validation Strategies for Sterilisation Processes
- Routine Operation of Sterilisers
- Continual Compliance Assurance
Pharmaceutical Sterilisation Principles in Practice®