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This intensive, interactive 4 day 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 Royal Society of Chemistry as suitable for their members’ continuing professional development.
Key Learning Objectives
- Provides aspiring QPs and other pharmaceutical quality professionals with the knowledge and understanding they need of the QP’s legal duties
- Demonstrates 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
- Will help you to understand what the QP must do themselves and what can/must be delegated to others, 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
Detailed QP Legal and Professional Duties
- Including a detailed review of the revised Annex 16
- Import scenarios
QP Code of Practice
- Implications for the QP
Current Challenges Facing the QP
- Proposed and recently implemented legislation and guidance
Product Certification/Release Criteria
- The risk-based decision making process
- To certify or not to certify?
EU Legislation and its Implications
Role of the QP in Complex Manufacturing Scenarios
- Annex 16 and beyond!
How to be an Effective QP
- Influencing skills and assertiveness
- Conflict management and coaching
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
Minimizing Human Error
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.
Course tutors will be:
- Peter Gough - Peter has over 40 years’ pharmaceutical industry experience, with over 20 years as a practicing QP, and is a former chair of the Royal Society of Chemistry’s QP Assessor panel.
- John McCool - John is a currently active QP who qualified in 2008 and has since worked for a range of companies from small virtual, academic institutions to large multinational companies.
- Erika Notman - An experienced QP, Erika is a former chair of the Royal Society of Biology’s QP Assessor panel.
- The Legal Duties of the Qualified Person
- Batch Certification by the QP – Annex 16
- What Gives a QP Confidence?
- Risk-Based Decision Making for the QP
- The QP Application Process
- My Journey through the QP Viva
- Education and Training of QPs
- The Relationship Between the QP and Regulatory Authorities
- EU and UK Legislation and Guidelines: An Update
- Human Error
- Leading with Influence
- The QP: What it is like in Real Life
- The Role of the IMP QP
- The Qualified Person: Code of Practice
- The QP as a Change Agent
- Keeping Up-to-Date
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