Two informative Workshops / Training Classes, led by Keith Shuttleworth of
KSA, are now offered:
EU Sterilization Explained
The EU approach to sterilization is complex and is based on a
variety of standards and guidance. This course provides delegates with the
context and understanding essential for any
US
company that needs to comply with EU regulations.
One day course –
Courses provide a
detailed insight in how to satisfy all the EU requirements for moist heat
sterilization. Topics include:
 |
History &
Regulatory background |
|
Cycle design
criteria |
|
Equilibration
times and other measures |
|
Bowie
Dick/DART tests - theory and practice. |
|
Steam quality
and steam quality testing |
|
Leak rate
tests and test specifications |
|
Test
frequency's |
|
Load
configurations for validation/revalidation. |
|
Choice of
biological indicators |
|
Long hold
times |
|
Air
detector’s |
Steam Quality Testing Master Class
On site - One day course
–
Courses will
provide delegates with a detailed theoretical and practical knowledge of all
aspects of steam quality testing. Topics include:
|
Steam quality
theory |
|
Test point
installation |
|
Health & Safety
|
|
Testing
techniques |
|
Hands on
training |
|
Troubleshooting |
 Keith
Shuttleworth
is the
Senior Consultant at KS & A, which provides a range of specialist products,
consultancy and training services associated with sterilization processes and
steam quality testing to an international market. He has some 25 years practical
experience in the procurement, commissioning, validation and maintenance of
sterilizers. Keith was registered as an Authorised Person (Sterilizers) in
October 1994 and is currently a member of the British Standards Institute
Committee
CH/198
(Sterilization of Medical Devices),
is Chair of
the P&HSS Sterilization Special Interest Group and has been a member of the PDA
Taskforces for Sterilizer Validation and SIP Technical Reports. Keith has
provided a wide range of presentations for ISPE, PDA and P&HSS, in addition to
providing numerous in house training sessions throughout the world (including
the UK’s
MRHA Inspectors).
For both courses delegates will receive comprehensive notes and
Certificates of Attendance. Formal assessments and Certification of Competence
available on request.
Classes are now forming - Please contact us for details
Info Request
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