J E M O Limited
Auditor Training, Assessment & Consultancy
Established since 1984
Pharmaceutical Course
Pharmaceutical Internal Auditor Training Course
{A TWO DAY COURSE SPECIFICALLY DESIGNED FOR THE PHARMACEUTICAL INDUSTRY AND ITS SUPPLIERS}
The standards against which the quality management systems are audited and on which the course is based can include:
|
The PS 9000 series (the Application Standards for pharmaceutical
suppliers based
on ISO 9001and including GMP)
| |
| ICH Q7A | |
| ISO 15378 – Primary packaging GMP standard | |
| EU Good Manufacturing Practice (GMP) | |
| Good Laboratory Practice (GLP) | |
| ISO 17025 (replacement to NAMAS 10 laboratory standards) | |
| ISO 13485 (medical devices) | |
|
ISO 9001: 2008
Others (e.g. internal company
standards)
|
Download the course infomration
Audits (self inspection) are a routine part of today's quality management. Because of the regulatory regime of the pharmaceutical
industry, auditors frequently focus on non-compliance. Whilst essential to retaining the marketing authorisation, this approach often
misses the important improvement opportunities which may benefit the business.
The course is structured in modules which provide
flexibility to meet individual client needs. The programme is designed to fit in with individual client working times and other
operational requirements and can be tailored to the needs of the client.
The two-day programme can be run consecutively or split
to meet the client needs.
A heavy emphasis is placed on practical application of what has been taught and the second day is devoted
to practical auditing in the client's facility.
or contact us for more information
“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”
Who should attend
This workshop is designed for people who have some practical experience of auditing to a base-line standard
such as ISO 9001.
It is also applicable to people who operate in the support role during audits (e.g. technical specialists).
It
can also provide a useful foundation for internal auditors who plan to make the transition to pharmaceutical supplier auditors.
More information and get a quote
All of our courses can be customerised to your needs normally with no extra cost. Please feel free to contact us for more details
and/or request a competitive quote. Contact us on contact@jemoltd.com phone +44 (0) 1249 44 75 44 or complete our Enquiry
form
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