The Role and Professional Duties of the Qualified Person
This intensive, interactive four-day 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 will help you to understand what the QP must do themselves and what can/must be participant to others, it will provide advice on how the QP should work in tandem with professionals in other departments, and will stress the non-technical “people” skills that are essential to being a good QP.
The role and duties of the QP are constantly changing and the revision of EU GMP Annex 16 introduces some significant new expectations. It is, therefore, essential that QPs keep up to date. This course covers these new challenges in detail to help you understand them and their impact.
Of paramount importance is the ability to focus on the broad issues of managing quality and to bring these issues together in a cohesive way when making decisions to certify medicinal products. Throughout the course you will have the opportunity to test your skills via interactive “release or reject” scenarios.
The course will also include a simulation of a typical UK QP assessment interview as conducted by the three professional bodies.
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 course is approved by the Royal Society of Chemistry as suitable for their members’ continuing professional development.
*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.
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.
Key Learning Objectives:
- To understand the QP’s legal and professional duties - A detailed review of Annex 16 - Import scenarios for products and APIs - Role of the IMP QP - Expectations for contract QPs
- To understand how to be an effective QP - What really gives a QP confidence to release batches - Risk-based decision making - Impact of human factors - Management of regulatory inspections - The non-technical ‘people’ skills that are essential to being a good QP; e.g. influencing, assertiveness and leadership
- To consider the role of the QP in complex manufacturing scenarios
- To know the routes to becoming a QP across the EU and the UK assessment procedure - Including a simulation of a UK QP viva
- To understand proposed and recently implemented EU, ICH and UK legislation and guidance
- To understand the QP Code of Practice
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
- 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.
Why choose NSF International, Pharmaceutical Services
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert pharmaceutical training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.
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