| Documentation/Configuration
Management Certificate
Program Overview
Documentation and
Configuration Management has become an increasingly critical
function within Medical Device companies. Documentation and
Configuration Management crosses all department boundaries as
companies are required to be compliant with FDA requirements
and legislation. Configuration Management requires strategic
planning and maintenance to ensure that a company’s documentation
system is efficient for daily operations as well as effective
for potential retrieval and recall.
This certificate program prepares students to work in positions
involved with documentation or configuration management within
the medical device and products industry. Graduates will work
in developing and managing documentation and configuration systems
within companies. Classes include specific biomedical technology
coursework in storing, managing and retrieving medical device
documentation.
Documentation/Configuration Management Certificate
Required Courses
| |
Design & Manufacturing in the Medical Device Industry |
3 |
| |
Introduction to Medical Device Regulations/Ethics |
3 |
| |
Introduction to Documentation/Configuration Management |
3 |
| |
Introduction to Database Management for the Medical
Device Industry |
3 |
| |
Technical Writing for Regulated Industries |
3 |
| |
|
|
| TOTAL
CERTIFICATE HOURS |
15 |
Course Descriptions
Design and Manufacturing in the Medical Device
Industry
This course provides
an introduction to the design and manufacturing of medical devices
with special focus on the unique design manufacturing challenges
that are necessary to achieve World Class Manufacturing (WCM)
excellence. The course describes the fundamental systems used
in the design, development, and manufacturing of medical devices
and how these relate to industry regulations. Specific topics
include: material and process selection considerations, aseptic
processes, clean-room techniques,, sterilization processes,
clinical testing, lot traceability, introduction to automation
and control systems, testing and instrumentation lab and manufacturing
controls.
Introduction to Medical Device Regulations
and Ethics
This course provides an understanding of the basics into the
Food and Drug Administration (FDA) regulation and compliance
with an overview of how the various activities and positions
within a medical device company are affected by regulations
using the FDA as the primary focus. Topics include the applicable
laws and regulations enforced by the FDA, an introduction to
international standards, the regulations controlling medical
device design and development, the medical device approval process,
laboratory and clinical studies, the introduction to the Quality
System Regulations (QSRs), and the FDA inspection process.
Introduction to Documentation/Configuration
Management
This course is targeted to individuals and/or teams interested
in establishing and managing documentation and related systems
in medical device manufacturing. The curriculum introduces students
to the fundamentals of governmental requirements that impact
medical device documentation, the benefits and elements of a
documented configuration management system, and the details
to establish related systems, policies, procedures and tools.
Database Management for the Medical Device
Industry
This course introduces students to the opportunities and challenges
offered by Database Management in the Medical Device industry.
Database management is a complex field with responsibilities
for organizing data from many sources, assuring data integrity,
and helping to design systems and software to run on those systems.
This course covers relational databases, programming languages,
life cycles, validation, compliance, security, backup and archive,
ethics and privacy, regulations and regulators. Coursework includes
database model comparisons, vendor demonstrations, setting up
your own company’s validation procedures, security model, and
code of ethics.
Technical Writing for Regulated Industries
This course provides instruction in the rhetorical principles
and strategies of technical writing as they apply to documentation
in regulated industries. The course emphasizes technical writing
for documents used in regulatory-compliant electronic or hybrid
systems. |
