Design Control (QSR 21 CFR Part 820/ ISO 13485)
This course is specifically adapted for the European audience.
Why do you need design control/ defined development processes?
Are these invented by the regulatory authorities as a bureaucracy measure/ burden to punish development teams across the globe?
Discuss and explore the (real) root causes for the existence of development processes/ design control.
Medical device products with their development do own some or all of the following attributes:
high product design complexity
need for interfacing with humans efficiently when launched
containing safety relevant features
development requires an interdisciplinary team
teams are working together across the globe
The course content is directed to guide your team on a successful medical device product development:
structured development approaches
using "best practice" and compliant processes in a scalable manner
the development processes interact appropriately
and to gain respective regulatory approval in addition.
Make sure your design process is compliant so you can avoid costly deviations. The FDA has identified design control as a key area in its QSIT top-
Understand the reason for design and development processes and their role in the regulated medical device industry.
Learn about critical development processes and their interaction during in-
Explore the differences between US design control requirements/ perspective (21 CFR Part 820) and the European regulatory perspective (ISO 13485).
project phase and milestone model for product life cycle
design and development planning
design inputs and design outputs
integration of risk analysis
corrective and preventive actions (CAPA)
teams and process ownership
compliant records/ design history file (DHF)
working with vendors
Who Should Attend
All team members participating in an interdisciplinary medical device product development, responsible to built a robust compliant environment e.g. project management, system engineers; software, labeling, assay development, reagent/ instrument/ disposable manufacturing, service, quality assurance and regulatory affairs.