Pharmaceutical Packaging - an introductory course

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Tutor : Chris Penfold
DateLocationFee 
25 June 2018
London
London£620
£558 + Vat
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Before 25 May 2018
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Before 25 May 2018

Overview

Pharmaceutical Packaging is a very specialised area with its own unique issues and problems. This one day course will provide delegates with a good basic grounding and appreciation of what is required for the packaging of pharmaceutical and healthcare products. Whether you know nothing, have a basic understanding or are familiar with the area, this course will provide you with the useful knowledge and insights from an expert who has worked in the industry for over 25 years.

What the course covers

  • Packaging component and material selection
  • Key properties of various packaging materials/systems
  • Pack testing and evaluation
  • Packaging component specifications
  • Printing processes and controls
  • Artwork generation and control
  • Regulatory requirements eg MA packaging requirements, Braille, 2D Data Matrix barcodes, Child resistance, Tamper Evidence, Readability and others
  • Transit packaging
  • Trade/Supply Chain requirements

Who Should Attend?

  • Account Managers
  • Artwork Producers
  • Auditors
  • Business Developers
  • Clinical Trial Suppliers
  • Logistics Personnel
  • Packaging Design/Labelling Personnel
  • Project Managers
  • Purchasers
  • Quality Assurance and Control Personnel
  • Regulatory Personnel
  • Suppliers to the industry
  • Technical Writers

Course Programme

New Product Development (NPD) and role of packaging

  • Definition of packaging in a pharmaceutical context
  • Packaging in the pharmaceutical NPD process
  • Main packaging formats and materials - Quick overview
  • Key product requirements & characteristics
  • Consumer
  • Shelf life
  • Regulatory considerations
  • Marketing expectations

Key properties of various packaging materials/systems

  • Primary packaging
  •         - Glass, plastics, metal - bottles, closures, blisters, manufacture,           benefits, potential issues & testing

            - Laminates, tubes, aerosols " manufacture, benefits, potential issues &           testing
  • Secondary packaging
  •         -  Pharmaceutical labelling - labels, leaflets (PILs), cartons

  • Tertiary /Trade/ Transit Packaging
  •          - Top-line overview - corrugated & retail packaging

             - Materials, printing & supply chain issues

  • Main barriers and benefits of various packaging materials
  • Key drivers for the pack performance
  • Supply chain implications on the packs
  • Specifications
  • Environment
  • Considerations of risk

    Pack testing and evaluation

  • Proving Compatibility and ICH testing
  • Extractables and leachables
  • Extraction, migration & sorption studies
  • Artwork generation and control
  • Establishing processes suitable to your business needs:
  •          - Wording, Templates, Creation, Workflow, Version control and authorisation

    Regulatory & GMP Requirements
  • Key packaging data for the MA/Dossier
  • Common Technical Document
  • Summary of Product Characteristics (SmPC)
  • Emerging Pharmaceutical Legislation
  • DQSA " Drug Quality & Security Act
  • Falsified Medicines Directive
  • Other Markets
  • Some special requirements for packaging
  • Medical Devices - Briefly:- Categories,
  • CE Marking Requirements
  • Child Resistant Closures
  • Tamper-Evidence
  • Braille
  • Readability
  • Patient Compliance
  • Bar Coding
  • Security & combating counterfeiting
  • Emerging requirements (e.g. 2D Data Matrix barcodes and serialisation)
  • Trade/supply chain requirements
  • Understanding the various markets and their particular requirements
  • Understanding trade requirements - e.g. Barcodes, Tamper Evidence etc.

  • What people said about Pharmaceutical Packaging - an introductory course

    "Lots of actual packaging to look at, really good"

    "Good overview of packaging, fitting all aspects together"


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