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 Course Description
This unique 5-day course is highly recommended
for anyone concerned with the quality management systems operated by suppliers
of starting materials to the pharmaceutical industry. It has been developed and
run over many years in the UK,
Europe and the Far East
The course is based on GMP as it relates to
starting materials and specified in the PS 9000 series of standards and ISO 15378. 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 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
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 endorses the PS 9000 series and some of its inspectors have
attended the course.
 Who Should Attend?
The course is designed for Quality Assurance, Quality Control and
Purchasing Professionals from Pharmaceutical Companies and Suppliers. It is also very
useful for auditors from third
party certification bodies. In the UK, delegates have attended from
BSI, DNV,LRQA and SGS. The
course is highly recommended to
existing and intending Qualified
Persons (QPs) as part of their Continuous Professional
Development (CPD). It is not essential, but recommended that delegates have
some prior knowledge of the ISO 9000:2000/8 series and PS 9000 & PS 9100 before
attending the course. We can help with this if required.
The course is registered by the International
Register of Certificated Auditors (IRCA) and meets their training requirements
for registration as Auditor and Lead Auditor. Successful delegates will not
only obtain invaluable experience and skills in auditing suppliers against the
new standards, they will obtain a qualification which is internationally
recognised. This
puts them on the same or a higher level of recognition than many customer and
certification body auditors.
 Benefits To Your
Business And You
The company benefits are significant. The MHRA, FDA
and other regulators report that the major causes of recalls of pharmaceutical
products are due to purchased items. It is therefore imperative that supplier
audits are done professionally so that you get a thorough understanding of how
quality of critical supplies are managed. IRCA registration also confers a
professional auditing status on individuals, which is recognised by customers
and regulators worldwide.
 Course Structure
Instruction and auditing practice are provided in a
series of build-up modules. The tutor(s) are practising
third and second party lead auditors and auditors in the pharmacutical sector and experienced trainers who
use the latest accelerated learning techniques. This involves the delegates in
practical learning exercises throughout the course. Experience has shown that
compared to the traditional U shaped table and slide presentation approach,
this technique improves delegate attention and knowledge retention and
significantly improves pass rates on the IRCA set written test.
 Successful completion of the Lead Auditor
course fulfils the training requirements, but the regulators also require
demonstration of successful auditing for registration as Auditor and Lead
Auditor. We offer a service of accompanying the auditors, usually on audits of
their suppliers, and in addition to providing our own auditing experience will
endorse the audit log sheets and other registration documentation.
 Clients Of The
Course
The following are some of the companies who have
sent delegates on this course:
Abbott Laboratories, AstraZeneca,
Aventis, Avecia (previously ICI), Boehringer Ingleheim, The British
Pharmacoepia, The British Standards Institute (BSI), Ciba Geigy, Courtaulds
Betts, Novartis, Cox Pharmaceuticals, Det Norske Veritas, Field Boxmore
Healthcare Packaging, Fauldings, Ferring Pharmaceuticals, GlaxoSmithkline
(GSK), Medica Packaging, MY Healthcare, Norton Healthcare, Rhone Poulenc Rorer,
Rexham Pharmaceutical Packaging, Roche Products, Roussel, Sanophi Synthelabo,
Serologicals, Taiwan Healthcare Executive, The UK Medicines Inspectorate
 Comments from
Delegates
The following are some of the comments from
delegates who have attended the course:
“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”
 More Information
Course Date: 2012 Couse Schedule
Course Venue: The Bailbrook House Hotel, Bath
Fee: the fee includes refreshments, buffet lunch and course notes - Non-residential £2,100+ VAT, We can arrange accomodation to suit your budget (e.g. cost with accommodation at the Bailbrook Lodge is £2,387.50 + vat )* 5% discounts are available for early booking or multiple bookings.
Book a place: Please register online or download the booing form
*The course is intensive and involves some evening work. We strongly recommend that
delegates have accommodation for the full duration of the course. We have made
special arrangements with 3 hotels to provide accommodation to suit individual
tastes and budgets. Our courses are run in dedicated conference centre in Bath, ample free car park, 2 miles from railway station and 1 hour from Bristol airport.
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Quality Management Systems Consulting, Auditing and Training Solutions
