Pharmaceutical Packaging - an introductory course

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Tutor : Chris Penfold
DateLocationFee 
17 & 18 June 2019
London
London£1,150
£1,035 + Vat
Book now for early bird price
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Before 26 April 2019
Book Now
Before 26 April 2019
2 & 3 December 2019
London
London£1,150
£1,035 + Vat
Book now for early bird price
Book Now
Before 28 October 2019
Book Now
Before 28 October 2019

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

Day 1

The Role of Packaging

Special Aspects of Pharmaceutical Packaging

Regulatory Overview

  • Agencies, Guidelines and Legislation
  • Dossier Requirements
  • International Conference on Harmonisation (ICH)
  • Common Technical Document (CTD)
  • Summary of Product Characteristics (SmPC)
  • Differences between Submissions in EU & USA
  • Emerging Legislation (inc. Issue Drivers & Technology Remedies) * Bar Coding (Briefly) - EAN, 2D - Datamatrix, QR * Counterfeiting & Product Security * Drug Quality & Security Act * Falsified Medicines Directive * Choice of Pharmaceutical Packaging
  • Compatibility & ICH Testing (All Zones)
  • Testing & Evaluation

Extractables & Leachables - Including a Case Study

Day 2

NPD Process & Role of Packaging

Main Pharmaceutical Packaging Formats & Materials

  • Primary - Key Properties & Cleanliness
  • Secondary - Pharmaceutical labelling " labels, leaflets (PILs), cartons
  • Manufacture, Benefits, Potential Issues, Testing & Printing

Trade / Transit Requirements

Specifications

Environment

Artwork Requirements

Some Special Requirements for Packaging

  • Medical Devices - Briefly:- Categories, CE Marking Requirements
  • Child Resistant Closures
  • Tamper-Evidence
  • Readability
  • Braille
  • Patient Compliance

Interactive Session


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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