Course description
Pharmaceutical Quality Systems
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.
Upcoming start dates
Suitability - 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.
Outcome / Qualification etc.
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
Training Course Content
- 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
Course delivery details
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.
All of NSF's pharmaceutical training courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
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Reviews
Average rating 4.8
The course was well paced and included lots of teamworks to consolidate learning.
Absolutely fantastic course - interactive, excellent tutors, supportive and brilliant training material. Inspiring! Most of all it was enjoyable from start to finish! Thank you!
Expenses
Discounts
Multiple participant discounts available. Discounts also offered to NHS staff, regulators and charities.
Excellent presentation and interactions, great teamwork. Really encouraging discussions. The rotating flipcharts presentations/group work was really good and the afternoon discu...