In this intensive, highly interactive four-day course you will learn the essential elements of an effective, compliant, modern pharmaceutical quality system and how to implement, monitor and manage a system to meet the needs of all the major international regulatory agencies. Learn how to simplify systems and add value to your company, not just cost!
A vast majority of adverse inspection findings relate to Pharmaceutical Quality Systems (PQS), this highly interactive course will help you decide if your PQS is effective, fit for purpose and working well, or if not, what to do about it!
The quality of your products depends on the quality of your people and the effectiveness of the PQS. Properly functioning, your PQS should be your business management system and should drive continuous improvement and cost saving.
As QPs and quality professionals, you can’t certify or release products and stay in business unless your PQS is in control.
Attend this course if you want to:
It is essential training for anyone who monitors part or all of the PQS and provides invaluable oversight for senior leaders. This course meets the requirements of Annex 16 and other key EudraLex chapters and annexes.
This course is also ÂÜÀòÉç approved as suitable for their members’ CPD.
Key Learning Objectives
On completion of this course delegates will know and understand:
Course Outline
Who Should Attend
The Aspiring Qualified Person
Our training is generally considered as the best available and our QPs are held in high regard within the industry.
As well as being accepted in the UK, our training courses are well known and accepted by several other 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 within 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.
Find out why you should choose NSF for your QP training by visiting our qualified person training section.
A vast majority of adverse inspection findings relate to Pharmaceutical Quality Systems (PQS), this highly interactive course will help you decide if your PQS is effective, fit for purpose and working well, or if not, what to do about it!
The quality of your products depends on the quality of your people and the effectiveness of the PQS. Properly functioning, your PQS should be your business management system and should drive continuous improvement and cost saving.
As QPs and quality professionals, you can’t certify or release products and stay in business unless your PQS is in control.
Attend this course if you want to:
- Learn how to do more with less
- Simplify your PQS to improve speed and flexibility
- Get your questions answered
It is essential training for anyone who monitors part or all of the PQS and provides invaluable oversight for senior leaders. This course meets the requirements of Annex 16 and other key EudraLex chapters and annexes.
This course is also ÂÜÀòÉç approved as suitable for their members’ CPD.
Key Learning Objectives
On completion of this 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
- 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 GDP
- Facilities, equipment and services management
- Validation
- QP relationships and release scenarios
- Deviation management
- Audits and self-inspections
- Complaints and recalls
- PQR, management reviews
- Continuous improvement and quality metrics
Who Should Attend
The Aspiring Qualified Person
Our training is generally considered as the best available and our QPs are held in high regard within the industry.
As well as being accepted in the UK, our training courses are well known and accepted by several other 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 within 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.
Find out why you should choose NSF for your QP training by visiting our qualified person training section.
