The Role and Professional Duties of the Qualified Person - QP Module 12

York
Monday, 21 July 2014
The Role and Professional Duties of the Qualified Person - QP Module 12
Monday, 21 July 2014 08:30 -
Thursday, 24 July 2014 17:00 (GMT)

Hilton York Hotel
EU,HS,BIO,PL,QP,CR,Q12
+44 (0)1904 648 111
1 Tower Street
York
YO1 9WD
United Kingdom

Map and Directions

    



The principal objective of this pharmaceutical training course is to emphasise how the QP should conduct themselves in discharging their legal duties.

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, therefore, delegates will have the opportunity to test their skills via interactive ‘release or reject’ scenarios.

The role and duties of the QP are constantly being added to and it is essential that QPs keep up-to-date with these new expectations. This pharmaceutical training course covers these new challenges in detail to help you understand them and their impact.

The course will also include a simulation of a typical UK QP interview as conducted by the three professional bodies.

Course outline


The detailed legal and professional duties of the QP

  • What can and cannot be delegated to others
The QP Code of Practice
  • Implications for the QP
Current challenges facing the QP
  • Proposed and recently implemented
EU legislation and its implications

The role of the QP in complex manufacturing scenarios
  • Annex 16 and beyond!
How to be an effective QP
  • Influencing skills
  • Assertiveness
  • Leadership
  • Conflict management
  • Coaching
The course also includes the vital non-technical skills that a QP needs in order to be able to fulfil their responsibilities.

Links with other functional groups
  • The regulatory authorities and the inspectors
Product certification/release criteria
  • The decision making process
  • To certify or not to certify?
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
The future of the QP role

Discussion and Working Groups


A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.

Additionally, discussion periods, provide delegates with an opportunity to obtain answers to their specific questions and concerns.

Course Tutors

  • Mr Peter Gough
  • Mrs Erika Notman

Why This Training Will Benefit YOU

The Aspiring Qualified Person
  • This series of 12 modules held over a 21 month period has been carefully designed to meet the requirements for theoretical training detailed in the latest UK Qualified Person Study Guide and EC Directives 2001/82/EC and 2001/83/EC.
  • All our training courses provide practical, face-to-face tuition in sufficient depth to prepare you fully for the challenges that lie ahead.
  • 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.
  • Increasingly, companies are using these modules as part of a modular technical and professional development plan for their staff.
  • Additionally, many industry professionals attend the courses as part of their Continuing Professional Development.
  • This course is designed to lead to Postgraduate Certificate, Diploma and MSc qualifications depending on modules taken and work commitment by students. For further details, please contact Stella Pearson-Smith, our QP Course Administrator at QPpharma@nsf.org for more information

The start and finish times given are approximate, please contact our office for further information.

 

Contact Details

Payment Instructions

  • Payment Methods

    By Bank Transfer — We are happy to accept payment directly into our bank account so long as:
    • the full amount of the invoice is received net of all local and UK bank charges within 30 days from date of invoice
    • the payment timescale quoted at the bottom of our invoices is strictly adhered to
    • a remittance slip giving clear details of our invoice number is received at this office to coincide with the payment being credited to our bank account

    Our bank details will be sent with the invoice.

    By Cheque — Payment should be made by sterling cheque drawn on a UK bank and payable to NSF Health Sciences Ltd. Please ensure that the full invoiced amount, net of all local and UK bank charges, is received within 30 days from date of invoice. 

    Please note that, in both cases, if any bank charges are deducted prior to receipt, this amount will be re-invoiced to yourselves.

    By Credit or Debit Card — Using Regonline Secure Payment facility.

    Payments — A VAT invoice (if applicable) will be provided (VAT Reg No. GB 927 3679 85). Settlement must be received at least 10 working days prior to the course start date. Cancellations within 25 working days of the course start date are subject to charges (see Cancellations section below). If a Purchase Order number is necessary to effect settlement of our invoice, please provide.

    Cancellations — Written cancellations with a full refund will be accepted up to 25 working days before the start date of the course. A fee of 50% will be payable for cancellations received between 10 and 25 working days before the start of the course. Full course fees will be charged for cancellations received within 10 working days of the course start date. Delegate substitutions may be made at any time up to the start of the course. Refunds will be made within 30 days of receiving the written cancellation by the same method that payment was made.

    Late Payment Clause

    We understand and will exercise our statutory right to claim interest at 2.5% above the prevailing Bank of England base rate under the Late Payment of Commercial Debts (Interest) Act 1998 if we are not paid according to our agreed credit terms.

    The programme and other information contained on this website are correct at the time of publishing and are published in good faith. We reserve the right to make any changes which may become necessary.


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