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Pharmaceutical Training Course |  Sterilisation: Principles in Practice

Sterilisation: Principles in Practice

Intensive 3-Day Course

DATE

LOCATION

COST

RESERVE
7th - 9th September 2010 Novotel, York, U.K. £1,575.00 (€2,205.00) Reserve Online
       
8th - 10th February 2011 Honeyman Group Ltd, Barnard Castle, U.K. £1,575.00 (€2,205.00) Reserve Online

Course Description:

According to the EU GMP Guide Annex 1, the manufacture of sterile products is subject to special requirements in order to minimise 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.

This course provides both a theoretical foundation and a practical application of sterilisation equipment. Detailed guidance on current requirements for qualifying steriliser equipment and validating sterilisation processes is included in the scope of the programme. In addition, the GMP expectations for the routine operation, monitoring and control of sterilisation processes is also examined.

The course is compiled by industry professionals who have extensive experience in the pharmaceutical and medical devices industries, and is designed to present an independent view of sterilisation techniques and processes. The course has run for many years worldwide and is regularly updated, based upon the experience of the tutors, and represents current best industry practices.

'Lecturer’s knowledge of topics discussed and all related and/or ancillary subject matter related to our industry was boundless, his expertise is unrivalled'
Serum Processing Technician, Immucor Inc, Atlanta, USA

Who Should Attend?

The satisfactory design, installation, validation, maintenance and management of sterilisation processes demands a multi-disciplinary team approach. The course will be relevant for:

  • Validation and engineering professionals involved in sterilisation processes.

  • Microbiologists responsible for biological data and the use of biological indicators.

  • QA/QC personnel involved in the review and acceptance of sterilisation data.

  • Technical and regulatory compliance and validation support staff.

  • Sterilisation system owners and users.

Course Leaders:

Mark Thompson B.Sc. (Hons), C. Eng. M.I.E.E. Managing Director, Honeyman Group Ltd

Mark's prolific background in the pharmaceutical and medical device industry spans more than twenty years.   Various engineering management roles with the world’s largest household names including Eli Lilly, Rhone Poulenc Rorer and Smith & Nephew Medical have seen Mark leading engineering teams through an array of engineering projects driven by capacity relief, new product introduction, profit improvement and regulatory compliance.  A Chartered Engineer and Member of the Institute of Electrical Engineers, Mark primarily specialises in control and instrumentation projects within sterile manufacturing operations.     

 

Gavin Ross B Eng, AMIMechE, Process Validation Manager, Honeyman Group Ltd

 

Heading up the Honeyman Group’s Technical Operations Division, Gavin is now heavily involved in conducting site feasibility studies and risk assessments for a number of major clients across the world. Specialising in sterile product manufacture and aseptic processes, Gavin spent the early years of his career with leading household names such as Smith and Nephew.

Gaining a wealth of experience in the fields of engineering, QA validation and latterly change control, Gavin was involved in several major projects relating to technical change and new technology introduction, cleanroom design and specification and site wide change control management.

 

In addition to the leading course tutors, other well-qualified and experienced speakers from industry will be present throughout the course.

 

Course Language:


The course will be delivered in English.

Pharmaceutical Water Systems   Sterilisation and Depyrogenation   Analytical Services and Testing 
Pharmaceutical Training Courses   Pharmaceutical Process Consultancy   GMP Regulatory Compliance

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