QP role and professional duties

2 Day/s

CPD Hours: 14

Classroom, online, in-house

RSC approved

A Qualified Person (QP) must certify that each batch of medicinal product (for human or veterinary use) complies with its Marketing Authorisation or Clinical Trial Application, GMP and certain other requirements. Their conduct overall must comply with the Code of Practice for QPs.

This course provides a comprehensive overview of the requirements of the UK Study Guide and, by using interactive questions and scenarios, shows how the Qualified Person can comply with the legal and operational requirements of the role.

Classroom courses
Please note, the advertised venue may need to be changed, if the required number of delegates is not met. In this situation, the course will be converted to an Online Virtual course and all delegates notified accordingly. The decision regarding the venue will be made at least 4 weeks before the course is due to run.

RSC Logo Approved Training High Res (1)

The module is essential for all candidates who expect to take the QP Viva. It forms a valuable contribution to Continuing Professional Development for those QPs who qualified some years ago. Other managers and supervisors from within pharmaceutical manufacturing will benefit from attending this course as they will gain a thorough understanding of the relationship of the QP with their own role.

The course includes the following topics and reinforced using group exercises:

  • Day 1
    • Annex 16 - Knowledge check
    • Overview - role of QP
    • PQS & QP Oversight
    • MIA / MA / equivalent
    • Product Development
    • QP in Production
    • Batch Certification
    • Unexpected Deviations
  • Day 2
    • Storage and Distribution
    • Complaints and Recall
    • RSC Presentation - QP Application Process
    • Regulatory Inspections
    • Clinical Trials
    • Contract QP
    • Impact of Brexit

    By the end of the course you will learn and understand:

    • The legal responsibilities of a QP within the EU
    • The Code of Practice for the QP
    • An overview of the regulatory framework pharmaceuticals in the EU/EEA
    • The certification process for a medicinal product according to Annex 16 and other applicable guidelines
    • The QP and the Pharmaceutical Quality System
    • How to deal with typical product problem situations
    • The interpersonal skills associated with the role of the Qualified Person within the pharmaceutical industry
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Bring this course in-house

Special offer

Helping your training budget go further

We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

Meet the tutors

Neil Wayman

Neil is a Microbiologist with over 30 years experience in the pharmaceutical industry. Neil Treasurer of the Pharmaceutical Quality Group and actively involved in running the annual MHRA/PQG meeting. In 2012 he moved back to a role as QA Group manager, QP and RP on the license at AstraZeneca’s second largest manufacturing site at Macclesfield in Cheshire with primary responsible for the site QMS, internal and external inspections, licensing, issue management and recall. In 2018 he moved to AstraZeneca Corporate Quality as Global Quality Director primarily responsible as Global Business Process Owner for Complaints.

Rob Hughes

Rob Hughes has over 30 years in the pharmaceutical industry spanning various operational, project and senior strategic leadership positions in commercial manufacturing and development QA. Rob, a practising QP, has experience of the application of QA in many different areas including control laboratories, API, solids, creams and liquids manufacture, and third party audit and evaluation. Rob has many years experience of MHRA and FDA inspections.

RSC QP Registration Standards Specialist

David Moulding, Registration Standards Specialist at the Royal Society of Chemistry (RSC), will be delivering a presentation covering QP Eligibility and the Application Process.

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