九州影院

Key Learning Objectives

On completion of this course, delegates will know and understand:

• The QP鈥檚 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

Course Outline

Detailed QP Legal and Professional Duties

• 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

Product Certification/Release Criteria

• 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

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 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 in 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

Prerequisites

For any queries regarding entry requirements for both QP training and/or postgraduate qualifications please

Additional information

NSF delivers instructor-led QP courses with blended training methods, in a mix of virtual and in-person courses. . If you cannot see your delivery method of choice, .