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 July2017.
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.
Who Should Attend This Course?
The course is regularly attended by Engineers, Microbiologists, Technical, QA and QC personnel as well as Production and Operational personnel.
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