Pharmaceutical Quality Systems - QP Module

York
Monday, 12 March 2018
Pharmaceutical Quality Systems - QP Module
Monday, 12 March 2018 08:30 -
Friday, 16 March 2018 16:30 (GMT)

York Marriott Hotel
EU,HS,BIO,AS,GM,PL,QP,QM,Q9,CR
+44 (0) 1904 701 000
Tadcaster Road
York
YO24 1QQ
United Kingdom

Map and Directions

          
We all know that the quality of your products depends on the quality of your people and the effectiveness of your Quality Management System (QMS). In fact, as Qualified Persons (QPs) and quality professionals, you can’t release product and stay in business unless your QMS is ‘in control’. This is easier said than done. Supply chains are more complex than ever before and you are being asked to do more with less, and faster! It is not surprising that failures in QMS are a key reason for severe regulatory action in Europe and the USA.

This course will provide you with answers to some really tough questions.

What You Will Learn

  • How to meet the ever increasing demands of global regulatory agencies, both now and in the future
  • How to succeed when others have failed and implement ICH Q10 (Pharmaceutical Quality Systems) successfully throughout the product lifecycle
  • Contractors and third parties – how to manage quality across your supply chain, no matter how complex
  • How to simplify every aspect of your QMS to reduce bureaucracy and improve speed and flexibility
  • How the best in class manage quality to improve their competitive edge and improve regulatory compliance

Course Outline

  • Understanding regulatory trends and requirements (EU and FDA)
  • ICH Q8, 9 and 10: how to implement and maintain across the product lifecycle
  • How to manage quality at suppliers and third parties and maintain ‘quality oversight’
  • The essential elements of an effective and simple documentation system
  • Validation: the ‘modern paradigm’
  • Deviation reporting systems that drive continuous improvement
  • Simple and effective change management (yes, it is possible!)
  • Complaints and recall procedures that work
  • Technical agreements: management of third parties
  • Good distribution practices and cold chain management
  • Audit and self-inspection: designing and implementing sensitive and reliable programmes
  • The role of senior management and the ‘quality professional’
  • Risk management and risk-based decision making

Discussion and working in 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, including a course tutor panel session, provide delegates with an opportunity to obtain answers to their specific question and concerns.

Course Tutors

  • Mr Martin Lush
  • Mrs Liz Allanson
  • Dr David Selby

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

    Please note that for customers outside Europe we can only accept credit card payments, we do not accept purchase orders.

    By Bank Transfer 
    — We are happy to accept payment directly into our bank account so long as:

    • a purchase order number is provided (if required my your company)
    • the full amount of the invoice is received net of all local and UK bank charges at least 10 working days prior to the course start date
    • 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:

    Account No.: 50144499 – Sort Code: 60-16-30

    IBAN: GB38NWBK60163050144499

    SWIFT: NWBKGB2L


    By Credit or Debit Card — Using Regonline Secure Payment facility. The total purchase price (including VAT if applicable) and service charge will be displayed prior to confirming the order.

    VAT Invoice — A VAT invoice (if applicable) will be provided (VAT Reg No. GB 663 2419 39).

    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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