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Pharmaceutical Training Course | Advanced Sterilisation Validation and the Application of Biological Indicators

Advanced Sterilisation - Validation and the Application of Biological Indicators 
 
Intensive 2½ Day Course
 

DATE

LOCATION

COST

RESERVE
15th - 17th December 2010 Novotel, York, U.K. £1,295.00 (€1,815.00) + VAT Reserve Online
       
15th - 17th June 2011 Honeyman Group Ltd, Barnard Castle, U.K £1,295.00 (€1,815.00) + VAT Reserve Online

Course Description:
The validation of sterilisation processes is becoming an increasingly expensive and time-consuming exercise. Developing the correct strategy for the validation and planning the approach up front will significantly reduce problems and expense in the execution stage. Building upon the foundations delivered by our "Sterilisation - Principles in Practice" course, this two and a half day training course delivers a comprehensive review of the performance qualification (PQ) of sterilisation processes, including both thermal and biological validation.

The course utilises many practical experiences and case studies of validation exercises on a number of different sites, dealing with different regulatory bodies. Delegates have found this practical "real world" approach invaluable on previous courses that have been ran successfully throughout Europe.

Course Programme:

A summary of the course content is as follows:

  • Validation strategies and protocol preparation

  • Planning the validation workload for the most efficient delivery

  • Data logging and thermal measurement calibration and validation requirements - Validating the Validator

  • Biological Indicator (BI) application examples

  • BI population and D-value verification requirements

  • BIs for porous load, fluid loads and stopper cycles

  • Understanding the product effect on the D-value of biological indicators

  • Direct Inoculation case study and validation

  • Validation of stopper sterilisation cycles using stoppers which have been directly inoculated

  • Top 10 issues with sterilisation validation and how to avoid them

  • Strategies for handling and reporting deviations

Case Studies:

  • Validation of stopper sterilisation cycles. Direct inoculation of stoppers vs BIs.

  • Fluids Validation. Product effect on D value of micro organism. Use of Bioburden data.

  • Using biological validation data to reduce cycle times on fluids cycles. Cycle efficiency.

Upon Course Completion, Delegates Will:

  • Be aware of the current expectations for the validation of sterilisation processes

  • Be able to plan and execute the most efficient and compliant validation study

  • Understand how to handle deviations and out of specification results

Who Should Attend?

The course is designed specifically for:

  • Validation and engineering professionals involved in or responsible for the validation of sterilisation processes

  • Microbiologists responsible for the biological data and the selection and use of Biological Indicators

  • Quality Assurance Managers involved in the review and acceptance of validation data

Course Leaders:

Mark Thompson C.Eng. MIEE BSc
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 BEng: AMIMechE
Operations Director, 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.

Dave Chadwick
Senior Microbiology Consultant, Honeyman Group Ltd

Roles with some of the World’s leading research based companies including Shell And GlaxoSmithKline, followed by five years with Honeyman have resulted in Dave gaining an impressive knowledge of microbiological analysis, interpretation and troubleshooting. As the Honeyman Group’s Senior Microbiology Consultant, Dave has taken the lead role in a number of pioneering projects which have resulted in the development of new methods and techniques aimed at overcoming problems with existing standards and increasing the accuracy of the microbiological analysis of raw materials, finished products and medical devices.  Since the introduction of ASTM:2500, Dave has been increasingly involved in a number of risk based studies commissioned by clients to identify opportunities to minimise analytical testing and has latterly been instrumental in the establishment and operational management of the Honeyman Group’s new analytical laboratories in Dublin, Ireland.

Course Language:

The course will be delivered in English.

The Venues:

Rochestown Park Hotel, Cork, Ireland
Tel: +353 (0) 21 489 0800,     Fax: +353 (0) 21 489 2178,     Web:
www.rochestownpark.com

Pharmaceutical Water Systems   Sterilisation and Depyrogenation   Analytical Services and Testing 
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