Pharmaceutical Internal Auditor Training Course
{A TWO DAY COURSE SPECIFICALLY DESIGNED FOR THE PHARMACEUTICAL INDUSTRY AND ITS SUPPLIERS}
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
Pharmaceutical Course
More information and get a quote
 
“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”

If you have more 3 people to be trained, we provide a very competitive rate for in-company courses.  Please feel free to contact us for more details and request a quote.  Contact us on contact@jemoltd.com or complete our 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
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Hot off the press
PS 9000: 2011
Download the course infomration
Download the latest PS9000:2011 standard from PQG for free
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Medical Device Auditing to ISO 13485
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Good Distribution Practice (GDP)
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The standards against which the quality management systems are audited and on which the course is based can include:
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.
Who should attend
 
This course is designed for people who performs internal and supplier audit
 
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 other discipline internal auditors who plan to make the transition to pharmaceutical supplier auditors.
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Introduction to latest PS9000:2011
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  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)
 
Auditor Training, Assessment & Consultancy
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