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CPD Hours: 14
Classroom, online, in-house
It is very important for pharmaceutical companies to plan carefully for all Good Manufacturing Practice (GMP) inspections, as a successful outcome is required for continued operations. Careful management of the entire inspection process will also help ensure a successful outcome. It is of fundamental importance to ensure the best possible outcome possible so this course will focus on those practical aspects from preparation through to follow-up after the inspection. It will focus on UK MHRA inspections, but also cover US Pre Approval Inspections. It will cover announced, unannounced and for cause inspections.
This is a highly practical course covering management of GMP inspections from initial preparation, to hosting the actual inspection and follow up from the inspection. It is suitable for any company or NHS site with a site authorisation associated with any activities involved in the manufacture of medicinal products.
By the end of this course you will have gained:
We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.
Sue has worked in the industry for over 38 years, principally in quality and technical roles. She has a wealth of experience having held European Director & VP level positions at companies such as Eisai and Shire. For the last 11 years, Sue has been an independent consultant providing services across all major dosage forms and more recently ATMPs.
Auditing to pharmaceutical standards
The course covers the EU GMP Parts I, II and III; PS 9000; ISO 17025; ISO 15378 and ISO 13485. Several elements of ISO 9001 (Quality Management Systems) are explored in detail.