Pharmaceutical Quality Systems Training
About This Course
Do more than just reduce costs. Learn how to simplify systems and add value to your company. In this intensive, highly interactive course you learn the essential elements of an effective, compliant and modern pharmaceutical quality system (PQS). We show you how to implement, monitor and manage a quality system that meets the needs of all major international regulatory agencies.
As QPs and quality professionals, you cannot certify or release products and stay in business unless your PQS is under control. A vast majority of adverse inspection findings relate to the PQS. Our course helps you decide if yours is effective, fit for purpose and working well or if not, you will learn what to do.
The quality of your products depends on the quality of your people and the effectiveness of the PQS. A properly functioning PQS should be a business management system that drives continuous improvement and cost savings.
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.
This course is offered either virtually, or in-person in York, UK. 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.
This pharmaceutical quality systems course is Royal Society of Chemistry approved as suitable for its members’ continuing professional development.
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
Course Tutors
Course tutors will be selected from the following:
- Catherine Kay
- Samantha Clack
- Vicky Baulch
- Pete Gough
- Rachel Carmichael
Discounts
Multi-delegate discounts available. Discounts also offered to NHS staff and charities.
Qualified Person Training With NSF
Watch the video
Deviation and CAPA Management
Quality Risk Management
Equipment Qualification and Process Validation
Additional Recommended Courses
Analysis and Testing
This highly focused, intensive four-and-a-half-day course, taught by leading scientists and former Quality Control Managers, is designed to provide the aspiring Qualified Person or pharmaceutical quality professional with the knowledge and understanding they need to be able to perform their duties with skill and competence when interacting with the Quality Control laboratories.
We will explain to you the strengths and limitations of analysis and specific analytical methods, we will advise you on how to apply the principles of quality management and GMP to the testing environment in a pragmatic, effective way, and we will advise you of the very latest “hot topics” with the regulators and how to ensure that your laboratories are in compliance.
This virtual blended training course will be delivered via a combination of an instructor-led virtual classroom and self-paced learning online. This will require an element of learning to be completed prior to the virtual classroom, as well as afterwards and this will be managed through our online Learning Management System. Full details, including timings for the instructor-led virtual classrooms, will be emailed following registration.
Tutors: To be confirmed
Price: £3555 excluding VAT (where applicable)
Course registrations will close 5 working days before the start of the course.
You can view our booking terms and conditions from here.
Multiple Delegate Discounts are available for delegates from the same company attending the same course.
The first delegate must pay full price. The second delegate will receive a 20% discount. The third and any subsequent delegates will receive a 50% discount. Charities, NHS staff are entitled to a 50% discount. (Proof will be required).
Medicinal Chemistry and Therapeutics
Originally designed for the QP, this training course is essential knowledge for qualified persons and all those working with pharmaceuticals. Demystify reference material from Patient Information Leaflets to Data Sheets. This intensive course will provide an understanding and break through the terminology.
Tutors: To be confirmed
Price: £3780 excluding VAT (where applicable)
Course registrations will close 5 working days before the start of the course.
You can view our booking terms and conditions from here.
Multiple Delegate Discounts are available for delegates from the same company attending the same course.
The first delegate must pay full price. The second delegate will receive a 20% discount. The third and any subsequent delegates will receive a 50% discount. Charities, NHS staff are entitled to a 50% discount. (Proof will be required).
Pharmaceutical Law and Administration
This highly interactive four-and-a-half-day course is designed to provide the aspiring Qualified Person and pharmaceutical quality professional with the knowledge and understanding of international pharmaceutical legislation so that they can carry out their duties with skill and authority. We will describe the laws, regulations and guidance that dictate how we must work on a daily basis, we will explain why these laws exist and how they come into being, we will describe the roles and responsibilities of the major international regulatory agencies and we will emphasise the key role that QP and pharmaceutical professionals must play to ensure compliance with international legislation in the interest of patient safety.
Tutors: To be confirmed
Price: £3780 excluding VAT (where applicable)
Course registrations will close 5 working days before the start of the course.
You can view our booking terms and conditions from here.
Multiple Delegate Discounts are available for delegates from the same company attending the same course.
The first delegate must pay full price. The second delegate will receive a 20% discount. The third and any subsequent delegates will receive a 50% discount. Charities, NHS staff are entitled to a 50% discount. (Proof will be required).