Pharmaceutical Packaging - QP Module

York
Monday, 15 January 2018
Pharmaceutical Packaging - QP Module
Monday, 15 January 2018 08:30 -
Friday, 19 January 2018 16:30 (GMT)

Hilton York Hotel
EU,HS,BIO,AS,GM,PM,QP,SC,Q8,CR
+44 (0)1904 648 111
1 Tower Street
York
YO1 9WD
United Kingdom

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Despite advances in technology, quality problems with packaging still continue to occur. Print origination and packaging processes continue to be a major reason for product recall! This module has been carefully designed to cover all important aspects of the packaging process, from selection of suitable components, pack design, packaging processes and their associated GMP challenges, through the supply chain to the patient. The course includes visits to a wholesaler and a pharmacy, with input from printed packaging component suppliers. The module aims to provide the necessary understanding of packaging materials and the packaging process to enable the Qualified Person to carry out his/her duties with knowledge and professionalism. Equally, the module will be of value to staff involved in Packaging Development, Packing Operations, QA and QC.

Course Outline


Packaging Components
  • Primary (contact) materials, their composition and properties
  • Choosing the most appropriate material for specific applications
  • Pre-treatment of components
  • Requirements for receipt and testing
  • Supplier considerations
Pack Design
  • Contact packaging components
  • Reducing the risk of mix-up
  • Industrial codes of practice, e.g. PS 9000
The Packaging Process
  • Packaging machinery – an overview
  • Packaging operations – the GMP challenges
  • Recalls – an overview
  • In-process controls
  • Automatic security and detection systems
Regulatory Aspects
  • Stability testing requirements
  • Labelling regulations
  • Marketing Authorisation Application requirements for packaging components
The Route to the Patient
  • Wholesale dealing – including a visit to a wholesaler
  • Retail pharmacy visit
Concerns for the QP
  • Counterfeits
  • Controlled temperature storage and distribution

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

Course Tutors

  • James Johnson, University of Strathclyde, Glasgow, UK
  • Mr Mike Halliday, NSF Pharma Biotech Executive Director
  • Dr Gary Rees
  • 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

    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 927 3679 85).

    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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