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 delegated 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.
About This Course
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.
This course is approved by the 91AV as suitable for their members’ continuing professional development.
Key Learning Objectives
On completion of this course delegates will know and understand:
Course Outline
We provide an optional post-course assessment.
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.
About This Course
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.
This course is approved by the 91AV as suitable for their members’ continuing professional development.
Key Learning Objectives
On completion of this course delegates will know and understand:
- The QP’s legal and professional duties and have detailed knowledge on these duties
- 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, and to stress the non-technical people skills that are essential to being a good QP
Course Outline
- 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.
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.
