Business Efficiency and Training Solutions

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Supplier Auditing course in Denmark

We have worked with the pharmaceutical industry for nearly twenty years and in this time have trained several hundred pharmaceutical lead auditors, many of whom have gone onto IRCA registration. Our clients for this and internal auditing (self inspection) include many of the major pharmaceutical manufacturers, their suppliers and the UK medicines inspectors. We are currently providing IRCA Lead Auditor training to the majority of the current and new MHRA inspectors.

With associates in the UK, Australia and Singapore, we offer a comprehensive range of classroom and distance learning training in pharmaceutical GMP worldwide. We also have an e-learning portal.

The following are the courses available:

Pharmaceutical Internal Auditor Course

This two day course is designed to meet the primary requirements of Section 9 of the EU Pharmaceutical GMP Guide and Clause 8.2.2of ISO 9001: 2000. It is highly practical and when run in the client’s facilities we can include live auditing. With our focus on flexibility we can tailor this course to meet the specific needs of different companies and various groups of employees.

Pharmaceutical Packaging Courses (PS 9000 and PS 9004 based)

PS 9000 is a unique “standard” which develops the basic requirements for quality management system (QMS) in ISO 9001: 2000 into the GMP requirements required by the pharmaceutical industry for the manufacture of primary and secondary packaging, printed leaflets, labels and other components used for its products. PS 9004 is a practical, hands-on guide to implementing PS 9000. Both documents have been produced jointly by the pharmaceutical industry and their suppliers.

We can provide a variety of tailor made in house courses that are designed to familiarise staff and management to whatever level is needed.   Back to top

Pharmaceutical Excipients Training (PS 9100 based)

PS 9100 is also a unique standard developed by the pharmaceutical industry and major suppliers of non-active ingredients (excipients). Building from the base-line of  ISO 9001: 2000, it specifies graded levels of GMP for excipients depending upon what the substance will be used for. For example, high level GMP equivalent to that used in the manufacture of pharmaceutical products is specified for inactive ingredients which are used in eye drops, whereas foundation level GMP applies to greases for certain types of ointment. 

We can provide a variety of tailor made in house courses that are designed to familiarise staff and management to whatever level is needed.   Back to top

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