Course Overview

  • “The site visits were extremely useful when considering the impact of packaging designs, and the application of GMP at different stages throughout the supply chain.” Daniel Doran / Lofthouse of Fleetwood, UK
  • “Really benefited from the visits to the Pharmacy and Distributor – excellent learning opportunity.” Waqar Mirza / Pharmaserve (NW), UK
  • “Very well delivered course; group activities very good and useful.” Simon Knight / Benchmark Vaccines, UK
  • “It has made me very aware of the importance and complexities of packaging.” Kevin Groom / Napp Pharmaceuticals, UK

A highly interactive 5 day course designed to provide aspiring Qualified Persons and other pharmaceutical professionals with the knowledge and understanding they need to be able to manage, oversee, control or audit all aspects of packaging activities, from the control of printed packaging components through to secure storage and distribution of medicines to the point of dispensing. This very popular course includes visits to key parts of the distribution chain.

About This Course

Why is packaging still the greatest source of recalls?

As a QP you must understand your risks, vulnerabilities and obligations and keep current with changing legislation and requirements.

This interactive course covers all important aspects of the packing process, from selection of suitable components, pack design and packing processes to their associated GMP and PQS challenges. This course provides a detailed review of the supply chain from starting components to patient. Design your ideal packing department and then get inspected! Take back to your workplace ideas for improvement.

Led by highly experienced industry experts, QPs, current consultants together with support from academic staff from one of the UK’s top schools of pharmacy.

This course is also Royal Society of Chemistry approved as suitable for their members’ CPD.

Key Learning Objectives

On completion of this course delegates will know and understand:

  • The QP study guide expectations for packaging
  • Background to different packaging materials and their selection, uses and control
  • Pack design considerations to protect the patient
  • Supply chain management from industry to the patient
  • Regulatory aspects of packaging
  • Stability and packaging
  • Packaging operations and their risks and control
  • New changes and challenges to packaging
  • Packaging issues and QP, QA decisions
  • FMD serialization and implementation
     

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

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 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.
  • 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.

Find out why you should choose NSF for your QP training by visiting our qualified person training section

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

  • Samantha Clack - Samantha has worked in the pharma industry for over 20 years, over half of which she has been an active QP at licensed packing facilities. Also an experienced auditor, Samantha has audited packaging facilities worldwide.

  • Erika Notman - With over 25 years’ experience in the production and control of pharmaceuticals, latterly working within a CMO, Erika has taken decisions on selection, maintenance and de-selection of suppliers of packaging materials.

  • David WaddingtonDavid has broad experience in QA and manufacturing management working with a wide range of different dosage forms for global supply including solids, liquids, sterile products, food supplements and natural products.

  • Mike Halliday - Mike’s experience in the industry has covered manufacturing management and quality assurance. Mike has a particular focus on QP development and training and PQS lead auditor training.

All above tutors eligible to act as a QP.

  • James Johnson University of Strathclyde, Glasgow, UK

Course Fees

Course cost (excluding VAT)  £3,395.00

DISCOUNTS AVAILABLE

Multiple delegate booking discounts available. Discounts also offered to NHS staff, regulators,
charities and some self-funding individuals – contact us for details

Have a question or want to book a place? Contact QPpharma@nsf.org - you can also register online by clicking below.

Register