IRCA Registered Pharmaceutical Auditor/lead Auditor Course
{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}
J E M O Limited
Established since 1984
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Pharmaceutical Internal Auditor Training
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Pharmaceutical Auditor/lead auditor Training
(IRCA registration no. A18237, mutually recognised by RAB/QSA*)
Book a place
“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 Venue:  The Guyers House Hotel, Chippenham UK
 
Fee: £2,100+ VAT.  The fee includes refreshments, lunch, course notes and IRCA exam 
* 5% discounts for early payment, 5% multi-booking if you have more than 2 people.  Only one offer is applied in each booking.  We can arrange accomodation to suit your budget (e.g. residentail cost is £435 for 5 nights)
 
 
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 or complete Enquiry form
Copyright © J E M O Ltd 2017 All Rights Reserved
J E M O Ltd Registered in England & Wales Reg. no 4933247
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COURSE
PS...Britain's best kept secret-PS 9000 &PS 9100
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Hot off the press
PS 9000: 2011
Course Dates: 18-22 Sep 2017 
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Medical Device Auditing to ISO 13485
Download the latest PS 9000:2011 pharmaceutical standard from PQG for free
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Good Distribution Practice (GDP)
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GMP For Pharmaceutical Packaging Awareness Workshop
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CQI Introduces a new Grade
Who should attend?
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Introduction to latest PS9000:2011
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Internal Audits - burden or opportunies?
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*This training course and certificate of attainment is recognized by RABQSA as meeting the requirement for RABQSA certification to QMS Auditor.
Auditor Training, Assessment & Consultancy
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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 (Exemplar as now they are called) (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.
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*New
ISO 9001:2015 Gap Analysis
Auditing & Implementation Tools
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Booking Form
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