This course provides an essential overview and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience
Pharmaceutical packaging is a very specialised area with its own unique issues and challenges. This introductory course will provide delegates with a good basic grounding and appreciation of what is required for the packaging of pharmaceutical and healthcare products.
A regulatory overview will be given by an expert in the field to ensure that all participants are fully aware of the requirements. The programme will then address the choice of packaging and discuss compatibility, ICH testing, extractables, and leachables. There will be detailed coverage of the role of packaging in new product development, together with the main pharmaceutical packaging formats and materials available. Sessions on trade and transit requirements, environment, artwork, and more specific areas such as child-resistant closures and tamper-evident packaging will complete the course and ensure that all delegates leave with a comprehensive understanding of all key aspects of this topic.
Benefits of attending:
- Gain a useful insight into packaging component and material selection
- Learn key properties of various packaging materials/systems
- Appreciate pack testing and evaluation
- Better understand packaging component specifications
- Hear about printing processes and controls
- Acquire knowledge on artwork generation and control
- Ensure that you comply with the regulatory requirements
- Learn about transit packaging
- Consider trade/supply chain requirements
Programme day one
The role of packaging
Special aspects of pharmaceutical packaging
- Agencies, guidelines, and legislation
- Dossier requirements
- International Conference on Harmonisation (ICH)
- Common Technical Document (CTD)
- Summary of Product Characteristics (SmPC)
Regulatory overview (continued)
- Differences between submissions in the EU and USA
- Barcoding (briefly) - EAN, 2D - datamatrix, QR
- Counterfeiting and product security
- Drug Quality and Security Act
- Falsified Medicines Directive (FMD)
Choice of pharmaceutical packaging
- Compatibility and ICH testing
- Testing and evaluation
- Extractables and leachables
Programme day two
New product development (NPD) process and the role of packaging
Main pharmaceutical packaging formats and materials
- Primary - key properties - glass, plastics, metals, blisters, laminates, tubes, aerosols, closures
- Secondary - pharmaceutical labelling - labels, leaflets (PILs), cartons
- Manufacture, benefits, potential Issues, testing
Some special requirements for packaging
- Medical devices - (briefly) - Categories, CE marking requirements
- Child-resistant closures
- Tamper evidence
- Patient compliance
Mr Chris Penfold,
Experienced Freelance Packaging Development Specialist and Consultant ,
Design Cognition Ltd.
Chris Penfold is a self-motivated, achievement orientated, confidant and creative leader with a proven track record in general and technical management. He is a packaging professional with over 25 years of packaging development and NPD experience working on £million-brands in the OTC, healthcare and Rx pharma arenas for ‘blue-chip’ multinational companies such as Glaxo (GSK), CIBA (Novartis), Boots Healthcare and Reckitt Benckiser Healthcare.
He is an MBA graduate and Chartered Marketer with extensive cross-functional experience in a broad spectrum of related disciplines, including marketing, supply chain, QC and production. An ‘International Player’ with experience working in various European countries, Middle East, North America and extended business trips to the Far East. Underpinned by proven interpersonal skills, the ability to make things happen and experience gained from independent international consultancy projects and running his own business, Design Cognition Ltd.
Specialities and Competencies:
Chris’ technical competence and commercial foresight underpin his expertise in design strategy and management. He has many years of experience in New Product Development, management, and delivery and has pioneered outsourcing opportunities by developing processes, best practice and new ways of working to deliver top and bottom-line business benefits – predominantly in the healthcare industry. This has included benefits through his large and reliable network of Far Eastern products and tooling sourcing, development and supply partners.
Chris’ extensive knowledge of all packaging principles and processes includes: plastics and plastic conversion processes, glass, laminates, paper/board together with knowledge of printing technology, reprographics and origination principles. He has an in-depth knowledge of healthcare legislation, including working at the ‘cutting edge’ of Braille implementation.
Whether you are new to the industry, have a basic understanding of pharmaceutical packaging or are more familiar with the area but looking for a refresher, this course will provide you with valuable knowledge and insights from an expert who has worked in the field for more than 25 years.
Those who would benefit from attending include:
- Account managers
- Artwork producers
- Business developers
- Clinical trial suppliers
- Logistics personnel
- Packaging design/labelling personnel
- Project managers
- Quality assurance and control personnel
- Regulatory personnel
- Suppliers to the industry
- Technical writers
81 Jermyn Street