Approved training courses
This course covers the essential elements of an effective, compliant and modern Pharmaceutical Quality System (PQS). You will learn how to implement, monitor and manage a quality system that meets the needs of all major international regulatory agencies.
Attend this course if you want to:
• Learn how to do more with less
• Simplify your PQS to improve speed and flexibility
Pharmaceutical quality systems training is for anyone who monitors all or part of a PQS. In addition to providing invaluable oversight to senior leaders, this course meets the requirements of Annex 16 and other key EudraLex chapters and annexes.
If you choose our virtual learning option, training will be delivered via a combination of an instructor-led virtual classroom and self-paced learning online. Full details will be sent to you following registration.
Key Learning Objectives
On completion of this pharmaceutical quality systems training course delegates will know and understand:
• What is a PQS and what is in a PQS
• Industry norms and best practices
• QP decisions
• How the PQS is applied throughout the lifecycle of a medicinal product
• How to demonstrate to inspectors and management that the PQS is effective
• The impact of culture on the PQS
Course Outline
• Principles and expectations of the PQS
• Product lifecycle
• PQS elements
• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q8, 9, 10 and the PQS
• Senior management and the PQS
• People – selection and development
• Documentation – data integrity
• Change management
• Supply chain management and Good Distribution Practice (GDP)
• Facilities, equipment and services management
• Validation
• QP relationships and release scenarios
• Deviation management
• Audits and self-inspections
• Complaints and recalls
• Product quality reviews (PQRs) and management reviews
• Continuous improvement and quality metrics
Who Should Attend
The Aspiring Qualified Person
• Our PQS training is generally considered as the best available and our QPs are held in high regard in the industry.
• As well as being accepted in the UK, our training courses are well known and accepted by several EU countries, including Ireland, the Netherlands, Austria, Hungary and Malta.
• You are more likely to become a QP with us than with any other training provider.
The Pharmaceutical Technical Professional
• Not all the people attending these courses intend to become QPs. Many use the training to develop as technical managers in other areas of pharmaceutical manufacture and control.
• Many industry professionals from a range of disciplines attend the courses as part of their continuing professional development. Taken with some of our other QP modules, this course is designed to lead to postgraduate certificate, diploma and MSc qualifications.
For any queries regarding entry requirements for both QP training and/or postgraduate qualifications please contact QPpharma@nsf.org
Additional infoNSF delivers instructor-led QP courses with blended training methods, in a mix of virtual and in-person courses. Please visit www.nsf.org/training for current dates. If you cannot see your delivery method of choice, please contact QPpharma@nsf.org
Class/lab
York
4 days
£3360.00 GBP (plus VAT)
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Use the options below to search through the growing list of chemical sciences training courses that have been approved by the Royal Society of Chemistry.
Courses are approved for CPD purposes only; approval does not imply they will fulfill any regulatory requirements.
