J E M O Limited
Auditor Training, Assessment & Consultancy
Established since 1984
IRCA Registered Pharmaceutical Auditor/lead Auditor Course
(IRCA registration no. A17128, mutually recognised by RAB/QSA*)
{This unique 5-day course is highly recommended for anyone concered with the QMS operated by supplier of starting materials and components to the pharmaceutical industry}
It has been developed and run over many years in the UK, Europe and the Far East and meets all of the training requirements for IRCA/PQG
& RABQSA auditor/lead auditor registration.
The course is based on GMP as it relates to materials specified in the PS 9000
series of standards, ISO 15378 and the ICH Q series. PS 9000 applies to contact and secondary packaging and printed components such
as labels and patient information leaflets; PS 9100 specifies graded levels of GMP for inactive materials dependent upon their use
(e.g. liquids for eye drops would have the same level as the GMP used by the pharmaceutical manufacturer, oils for external ointments
would have a lower level of GMP).
ISO 15378 is the International Standard for Primary Packaging Materials.
These standards have been developed over more than 15 years and are published in the UK by the Pharmaceutical Quality Group of the Chartered Quality Institute (CQI) and the International Standards Organisation (ISO 15378). The PQG is made up of quality executives from most of the major pharmaceutical companies and their suppliers. There is an associated certification scheme for company registration.
The UK medicines regulator
MHRA endorses the PS 9000 series and some of its inspectors have attended the course.
*This training course and certificate of attainment is recognized by RABQSA as meeting the requirement for RABQSA certification to QMS Auditor.
Who should attend?
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Quality assurance managers
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Quality control & purchasing professionals from pharmaceutical companies and suppliers.
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Third party certification auditors
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Qualified Persons (QPs)
“It opened my eyes to what professional supplier auditing is about”
“Superb explanation of the PS 9000 series of GMP standards and how to audit against them”
“Fulfilled my requirements completely”
“Illustrated throughout with pharmaceutical industry examples”
Course Dates: 26- 30 Mar 2012, Bath 10-14 Sep 2012, Bath
Course Venue: The Bailbook House Hotel, Bath
Fee: £2,100+ VAT. The fee includes refreshments, buffet lunch, course
notes and IRCA exam
* 5% discounts for early payment, 10% multi-booking for 2nd or 3d delegate(s),only one offer is
applied in each booking. We can arrange accomodation to suit your budget (e.g. residentail cost with nearby hotel is £345
for 5 nights)
Book a place
Please reserve your place by registering on-line or download the Booking Form and send it back to us. For further information,
please contact us on +44 (0) 1249 44 75 44 or complete our Enquiry form
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J E M O Ltd Registered in England & Wales Reg. no 4933247