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Procedure or documented procedure?
In many standards that exist there are often statements such as “there must be a procedure to control training records”. Whilst I am sure that none of you will disagree with a statement such as this there is an element of unclarity in the statement itself. It...
Documents required by ISO 9001
The ISO 9001 standard is the international standard for Quality Management Systems. During its review in the late 1990 they removed its “obsession” of needing a documented procedure to cover most tasks. This is because organisations vary in size and...
Audit preparation
I perform a number of audits throughout the year. Most are supplier audits but some are internal audits. In order to make the audits as efficient as possible I recommend good planning for the audit – rather than just turning up on the day and “going with...
ISO 9001 versus GMP – Part 2
A lot has been said about ISO 9001 in the pharmaceutical industry. This article tries to compare the two fairly. You should read Part 1 first to get some idea of the differences. One of the main problems of comparing GMP and ISO is that the two standards are not...About Inspired Pharma
We help people in pharma organisations to continually improve their regulatory systems to gain competitive advantage and ensure compliance.
We offer a wide range of highly praised and respected classroom and online training courses and also provide our global pharma clients with consultancy support. Our classroom courses are available on a public schedule and also can be customised for in-house delivery at a client site.
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Forthcoming Public Courses
June
12 Good Manufacturing Practice
19 Sterile Products
25 Pharma GMP Lead Auditor Dublin, Ireland
September
10 Pharma GMP Lead Auditor
19 Documentation and Records
October
09 Data Integrity
10 Good Distribution Practice
17 Good Manufacturing Practice
November
05 Pharma GMP Lead Auditor Manchester, UK
13 Internal Auditor
20 Sterile Products
27 Problem Solving
December
All pharma training courses held in Reading UK unless stated otherwise. Click on course name for full details.
Online courses available anytime anywhere
Good Distribution Practice (GDP)
Good Manufacturing Practice (GMP)
Pharma Quality Management Systems module
QP Medicinal Chemistry & Therapeutics module
QP Quality Management Systems module
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