Course description
The Role and Professional Duties of the Qualified Person
This intensive, interactive pharmaceutical training course is designed to provide aspiring QPs and other pharmaceutical quality professionals with the knowledge and understanding they need of the legal duties of the QP and, more importantly, how the QP must work with others to ensure that those duties and responsibilities are performed in the best interests of the company, the patient and society.
This course also helps you to understand what the QP must do themselves and what can/must be delegated to others. We provide advice on how the QP should work in tandem with professionals in other departments and stress the non-technical people skills that are essential to be a good QP.
When certifying medicinal products, it is of paramount importance that a QP has the ability to look at the broad issues of managing quality and to approach these issues in a cohesive way when making decisions to release or reject. Throughout the course youll have the opportunity to test your skills via interactive release or reject scenarios.
This course is approved by the Royal Society of Chemistry as suitable for their members continuing professional development.
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 course, delegates will know and understand:
- The QPs legal and professional duties in detail
- How the QP must work with others to ensure that those duties and responsibilities are performed in the best interests of the company, the patient and society
- What the QP must do themselves and what can/should be delegated to others
- How the QP should work in tandem with professionals in other departments
- The non-technical people skills essential to be a good QP
Training Course Content
Detailed QP Legal and Professional Duties
- Including a detailed review of Annex 16
- Import scenarios
Product Certification/Release Criteria
- The risk-based decision making process
- To certify or not to certify?
- Minimizing human error
Role of the QP in Complex Manufacturing Scenarios
- Release or reject?
Routes to Becoming a QP across the EU and the UK Assessment Procedure
- Education and training of QPs
- Simulation of a typical UK QP assessment interview procedure
Links with Other Stakeholders
- The regulatory authorities and the inspectors
- Preparing for regulatory authority inspections
How to be an Effective QP
- Influencing skills and assertiveness
- Leadership
- Conflict management and coaching
- QP Code of Practice
Implications for the QP
- Current Challenges Facing the QP
- Proposed and recently implemented legislation and guidance
We provide an optional post-course assessment.
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
Customer Outreach Award
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Our Customer Outreach Award is presented to trusted providers who are excellent at responding to enquiries, making your search quicker, more efficient and easier, too.
Reviews
Average rating 5
I learnt a lot more from the leadership elements than I expected, thanks! All elements of the course were excellent.
Really great trainers. I learnt a lot about behaviours - including my own. I now feel motivated to make a difference.
Expenses
Discounts
Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.
Really useful course. Brought everything together. Leading with influence session very interesting. Many Useful tools to use moving forward.