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
  • “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 four-day pharmaceutical packaging training 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 a modern packaging facility and warehouse.

Reigster

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, pack security and design/control of 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 packaging department and then get inspected! Take back to your workplace ideas for improvement.

This course is also Royal Society of Chemistry approved as suitable for their members’ continuing professional development (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 control and impact on product stability
  • Pack design considerations to protect the patient including labelling, anti-counterfeiting, tamper evidence and serialization
  • Regulatory aspects of packaging
  • Supply chain management from supplier selection to CMOs, distributors, storage, transportation and the patient
  • Packaging operations and their risks and control
  • New changes and challenges to packaging
  • Packaging issues impacting QP and QA decisions

Course Outline

Packaging Components

  • Primary (contact) materials, their composition and properties
  • Choosing the most appropriate material for specific applications
  • Artwork management
  • Requirements for receipt, sampling and testing
  • Supplier considerations, audits, agreements and standards e.g. PS9000

Regulatory Aspects

  • Stability testing requirements
  • Labelling regulations
  • Marketing authorisation application requirements for packaging components

Pack Design

  • Good design practices to aid the manufacturer, distributor, retailer and patient
  • Reducing the risk of mix-up

The Packaging Process

  • Packaging operations – the GMP challenges
  • Facility design considerations
  • Packaging machinery – selection and qualification
  • Automatic security and detection systems
  • In-process controls
  • Line clearance
  • Including a visit to a modern packaging facility

The Route to the Patient

  • Fundamentals of good distribution practice
  • Controlled temperature storage and distribution
  • Wholesale dealing – including a visit to a wholesaler

Concerns for the QP

  • Counterfeits – anti-counterfeiting, tamper evidence and serialization
  • Controlling packaging processes

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.

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.

David Waddington 

David 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.

Catherine Kay 

Catherine has worked in QA and production operations management roles and is eligible to act as a QP. She was instrumental in the start-up of a new oral solid dose manufacturing and packaging facility in the UK.

All above tutors eligible to act as a QP.

Course Fees

Course cost (excluding VAT)  £2,870.00

DISCOUNTS AVAILABLE

Multiple delegate booking discounts available. Discounts also offered to NHS staff, regulators and charities – 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

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