Design Control for Drug —Device Combination Products

Design Control for Drug —Device Combination Products

Barcelona, Spain

Course No 15313


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Mark A. Chipperfield
Corvus Device Limited, UK
Dr Jochen Heinz
Transcoject, Germany
Paolo Mazzoni
PTM Consulting, Italy
Maja Rybka
Quality Consultant, Germany
Lee Wood
F. Hoffmann-La Roche Ltd., 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

the definition of a Combination Product,
current status of guidelines and standards,
the elements of the Design Control process,
many of the relevant process interfaces (change management, vendor management, data handling),
Risk Management as an important tool for device and combination product development, and how to test and document Design Verification and Design Validation.

Case Studies are an integral part of the course programme.


“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 Directive, ISO 13485, ISO14971, 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. This model is extremely similar to the Product Realization section of ISO 13485. The Design Control process should follow the waterfall model as described in FDA’s Design Control Guidance for Medical Device Manufacturers.
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; 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 and standards 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.

It is the aim of this course to give an overview of the current requirements in Europe and in the US and to show how these requirements need to be translated in the development of drug – device combination products. You will hear from experienced presenters as they cover typical challenges and propose certain approaches to overcome these.

Target Group

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.


Regulatory Background
Requirements for Medical Devices and Drug Delivery Products (Single Integral Product, EU)
Requirements for Drug – Device Combination Products, USA
Design control requirements
Maja Rybka

Device Development - Challenges and Considerations
Integration of Medical Device development activities within large pharma
Significant Challenges
Recommendations to facilitate proficient Combination Product development
Mark A. Chipperfield

Further Quality System Elements for Medical Device Development and Design Control Interfaces
Document Management
Change Management
Deviation Management
Maja Rybka

Risk Management
What is a “Risk”
Regulatory background (Drugs, Medical Devices)
Risk Management as a design control element
Integration of Risk Management into the company
Paolo Mazzoni

Design Verification
Design verification as a design control element
Regulatory background
Verification levels
Test methods
Protocols, reports and documentation
Dr Jochen Heinz

Case Study I: Pre-Filled Syringes
Dr Jochen Heinz

Introduction to Human Factors Engineering
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
Lee Wood

Case Study II: Human Factors Validation
Introduction and example of Human Factors
Validation. Including:
Pre-requisites as part of design controls
Planning, Health Authority Submission, Ethics
Key considerations for study design
GMP Quality considerations
Key trends in regulatory feedback
Lee Wood

External Development
Vendor qualification and audits
Quality Agreements
Maja Rybka

Case Study III: Inhaler Development
Mark A .Chipperfield

Case Study IV: Autoinjector Development
Mark A. Chipperfield

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