Document Control and Records Management For Medical Devices—Available In-House
This 2 ½ day program provides participants with the skills and tools needed for quality improvement and compliance within their organization as related to the handling of documents and records. Course content utilizes real life scenarios with a variety of situations and case studies for analysis toward practical resolutions. Discussions with participants from other medical device companies and instructors will allow attendees to benchmark their documentation processes and practices within their quality management systems (QMS). The focus of this course is on how documents and records are controlled, the objective evidence required for compliance, and the linkages between documents and records to the various processes and activities within a QMS. Upon completion of this course, participants will be able to use documents and records as tools to facilitate compliance with the FDA’s Quality System regulation and ANSI/AAMI/ISO 13485:2003 as well as make decisions using the appropriate documentation and objective evidence.
Program At-A-Glance |
DAY ONE - 8:00 AM - 5:00 PM |
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DAY TWO- 8:00 AM - 5:00 PM |
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DAY THREE - 8:00 AM - 12:00 PM |
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Objectives
- Ability to use documentation as a tool to facilitate compliance with the Quality System regulation and the ANSI/AAMI/ISO 13485:2003 standard
- Implementation of your quality management system using classic systems architecture to establish appropriate links between core processes
- Ability to make decisions and use documentation and objective evidence for implementing change
Format
Course content utilizes real life scenarios with a variety of situations for examples and case studies. Discussions with participants from other medical device companies and instructors will allow attendees to benchmark their documentation systems.
Who Should Attend
This course is for professionals that have responsibility for making decisions related to the use of documents and records in the areas of change control, quality assurance, design, manufacturing, purchasing, regulatory affairs, FDA inspections, and ISO audits. AAMI recommends this course for those who have medical device experience and a working knowledge of the Quality System regulation and ANSI/AAMI/ISO 13485:2003(R)2009 standard.
In-house Only
To bring this program in-house, please contact Linnea Bowman at lbowman@aami.org or call +1 703-253-8283.
Faculty
Course faculty are drawn from an experienced group of quality system professionals. All course faculty have completed an instructor training program to ensure consistency and quality from session to session. The mix of industry leaders, consultants, and FDA personnel helps to ensure a balanced presentation of the design control requirements and paths to compliance.