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Course No 16944Design Control for Drug - Device Combination Products
16-17 May 2019, Copenhagen, Denmark
Tel.: +49 (0)6221 / 84 44 0 E-Mail: email@example.com
If you have any questions, please contact us:
Mark A. Chipperfield, Corvus Device Limited, UK
Dr Jochen Heinz, Transcoject, Germany
Paolo Mazzoni, PTM Consulting, Italy
Lee Wood, medHF Switzerland
This Education Course provides a comprehensive overview of the regulatory requirements for the combination of medical devices with drug products (EU & US). Participants will learn and understand
Case Studies are an integral part of the course programme.
- the basics – distinctions between drugs, devices and ‘combination products’,
- the current applicable regulations, standards and guidelines
- the key elements of the Design Control, Risk Management and Human Factors Engineering processes,
- many of the relevant process interfaces (change management, vendor management, data handling),
- specific presentations in quality systems, vendor management, design verification and human factors design validation.
“Combination Product” is a term defined by the FDA to cover various combinations of drugs, biologics and medical devices. Since 2002, there has been an Office of Combination Products (OCP) at the FDA. Alongside several historical guidances and regulations, the FDA has issued the 21 CFR Part 4 regulation on the current Good Manufacturing Practice (cGMP) requirements applicable to Combination Products, effective on July 22, 2013. In January 2015 FDA published the draft-guidance “Current Good Manufacturing Practice Requirements for Combination Products” which also brings more clarification to this topic.
In the EU, there is currently no equivalent term to “Combination Product”, a product is either considered a Medical Device or a Medicinal Product. Classification of the product is based upon the Primary Mode of Action (PMOA) and the intended use. Regulation is based upon the Medical Device Directive or the Medicinal Product Directive - however there are some recent and ongoing initiatives for change; the Medical Device Regulation, ISO 13485:2016, ISO14971, IEC 62366, ISO 9001, PS 9000 which impact the development activities within the pharmaceutical industry in future.
As a consequence, drug manufacturers who extend their development and/or manufacturing operations into delivery (Medical) devices; or vice-versa; may not only need to follow traditional cGMP approaches, but may also have to fulfil additional requirements of Regulation, Directives, Normative Standards and guidances. They will likely have to develop or enhance their quality system to satisfy these additional requirements.
The existing 21CFR820 Quality Systems Requirements (1996) defines several requirements including the Design Control development model which needs to be applied both pre- and post-production to the device constituent part of the Drug-Device Combination Products.
Additionally, the recent increase in attention to Human Factors Engineering; or Usability Engineering; has led many manufacturers into difficulties as they aim to prove high levels of intuitive use, use safety and efficacy of the drug delivery system as a whole - for a Combination Product it is no longer just about the drug. Again, regulation, directives, guidance, standards and review expectations continue to evolve in this area.
For the established pharmaceutical industry it can be a challenge to adopt new vocabulary and approaches (e.g. Design Control, Design Input, Design Output, Design Verification, Design Review, Design Validation, Design Transfer, etc.) into their existing and traditional development processes.
This Course is designed for all scientists, engineers, managers and executives from Pharmaceutical and Biotech Development Units, including Device Development, Packaging Development, Quality Assurance, Regulatory Affairs, Marketing, and Project Management, who are involved in the development, industrialisation and control of drug-device combination products.
Device Development - Challenges and Considerations
- Requirements for Medical Devices and Drug Delivery Products (Single Integral Product, EU)
- Requirements for Drug – Device Combination Products, USA
- Design control requirements
Further Quality System Elements for Medical Device Development and Design Control Interfaces
- Integration of Medical Device development activities within Pharma
- Significant Challenges & Experiences
- Combination product stability & shelf-life
- Control Strategy
- Product Remediation
- Recommendations to facilitate proficient Combination Product development
What is a “Risk”
Regulatory background (Drugs, Medical Devices)
Risk Management as a design control element
Integration of Risk Management into the company
Tools (FMEA, FTA, HACCP)
- Document Management
- Change Management
- Deviation Management
Case Study I: Pre-Filled Syringes
- Design verification as a design control element
- Regulatory background
- PRS and URS
- Verification levels
- Test methods
- Protocols, reports and documentation
Introduction to Human Factors Engineering
Case Study II: Human Factors Validation
- Introduction to discipline of Human Factors
- The current state of the regulatory environment
- The requirements of Human Factors Engineering as an activity under design controls, IEC62366 and ANSI-HE75
Introduction and example of Human Factors
- Pre-requisites as part of design controls: Planning, Health Authority Submission, Ethics Approval, Key considerations for study design, GMP Quality considerations, Key trends in regulatory feedback
Case Study III: Inhaler Development
- Vendor qualification and audits
- Quality Agreements
Some considerations when developing inhalation combination products
Case Study IV: Autoinjector Development
Some considerations when utilising syringes in autoinjector combination products
Case Study V: Integrating Design Controls, Risk Management and Human Factors
Ensuring integrated key concepts during development and post-market activities