Dates - 5th July 2012, 18th October 2012
Price - £580 + VAT
The revision of Chapter 1 [Quality Management] and Chapter 2 [Personnel] of Part I of the EU Guide to GMP to bring it in line with ICH Q10 will mean an increasing regulatory focus on senior management responsibility for quality within an organisation.
This stimulating workshop is designed to make delegates think about where such responsibilities lie within their own organisation, and poses the important question of the ‘Cost of Quality’ versus the ‘Cost of Non-Compliance’.
Starting with a brief consideration of the key elements of the proposed revisions to the GMPs, the course moves through a series of case study scenarios and the consequent implications. Potentially business critical situations are explored to identify root causes and effective remedial and preventive actions.
Suitability
This workshop is a must for anyone with responsibility for ensuring GMP compliance within their organisation including those at senior management level.
Learning Outcomes
By the end of the workshop you will:
• Understand the potential impact and cost to of non-compliance
• Have learnt how root cause analysis identifies the level of responsibility to take action to ensure compliance
• Appreciate the importance of ownership to ensure compliance
• Realise the benefits of effecting a ‘Quality Culture’
To book a training course, please download the booking form,
complete and email to bookings@rssl.com