Pharmaceutical Sterilisation: Principles in Practice®
: 17 Sep 2019 - 19 Sep 2019
This is 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.
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.
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.
Optional: Teesside University Accreditation Assessment is an option is a bolt-on for this course – click here for more info