ISO 11737-1 Bioburden estimation Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 1: Requirements
12:00
Lunch
13:00
Syndicate exercise
David Allison
13:30
Syndicate feedback
David Allison
14:00
MICROBIAL INACTIVATION KINETICS
David Allison
Implications Sterilization of medical devices – Requirements for a terminally-sterilized device to be labelled “sterile”
14:45
Coffee/Tea
15:00
GENERAL CONSIDERATIONS
David Allison
Sterility testing
Pharmacopoeia 'Test for sterility'
'Test of sterility' Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the validation of a sterilization process
16:00
BIOLOGICAL and CHEMICAL INDICATORS
David Allison
Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
17:00
Close
Evening
Homework/Individual exercises
Delegates
Tuesday 24 April 2012
Time
Subject
Tutor
09:00
RADIATION STERILIZATION
Arne Miller
The nature of ionising radiation and the measurement of dose (gamma, electrons, X-rays)
ISO 11137-1, -3 Sterilization of medical devices – Validation and routine control of sterilization by irradiation
10.15
Coffee/Tea
10:30
RADIATION STERILIZATION
Eamonn Hoxey
ISO 11137-2 – Establishing the sterilization dose
12:00
Lunch
13:00
RADIATION STERILIZATION cont..
Eamonn Hoxey
14.30
RADIATION STERILIZATION(IQ, OQ and PQ)
Arne Miller
Installation Qualification, Performance Qualification and Routine Control
15.00
Coffee/Tea
16:00
RADIATION STERILIZATION(IQ, OQ and PQ) cont..
Arne Miller
17:00
Close
Evening
Homework/Individual exercises
Delegates
Wednesday 25 April 2012
Time
Subject
Tutor
08:30
HEAT STERILIZATION
Eric Dewhurst
ISO 17665 Sterilization of medical devices – Validation and routine control of sterilization by moist heat
09:45
Coffee/Tea
10:00
HEAT STERILIZATION cont..
Eric Dewhurst
11.00
ETHYLENE OXIDE
Eamonn Hoxey
ISO 11135 Sterilization of medical devices – Validation and routine control of ethylene oxide sterilization
12:00
Lunch
13.00
ETHYLENE OXIDE cont..
Eamonn Hoxey
13.15
Syndicate exercises
Eamonn Hoxey
13:45
Syndicate feedback
14:15
LIQUID CHEMICAL STERILANTS
Eamonn Hoxey
ISO 14160:1998 Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilant
15:00
Coffee/Tea
15:15
LIQUID CHEMICAL STERILANTS ..cont..
Eamonn Hoxey
16:00
ASEPTIC PROCESSING
Eric Dewhurst
ISO 13408-1 Aseptic processing of health care products – Part 1:General requirements
17:00
Close
Evening
Homework/Individual exercises
Delegates
Thursday 26 April 2012
Time
Subject
Tutor
09:00
CLEAN ROOMS
EN ISO 14644 –x:1999 Clean rooms and associated controlled environments
Charlotte Rudbäck
10:00
Coffee/Tea
10:15
GENERAL CONSIDERATION
Eamonn Hoxey
The future direction of sterilization standards.
ISO 14937 General Requirements for Sterilization of Medical Devices
Conclusion of the revision process for EN 550, EN 552 &EN 554
12:00
Lunch
13:00
AUDITING TO THE STANDARDS / AUDIT PLANNING
Eamonn Hoxey
13:30
Syndicate exercises
Eamonn Hoxey
14:00
Syndicate Feedback
Eamonn Hoxey
14.30
AUDIT REVIEW
15:00
Coffee/Tea
15:15
AUDIT REVIEW
16:00
QUALITY SYSTEMS LINKS
ISO 13485:2003 Quality management systems – Medical devices – Requirements for regulatory compliance
