LINKS

• QS Training Home
• Corrective and Preventive Action
• Design Control
• Documents and Records
• EO Sterilization
• Human Factors
• Industrial Sterilization
• Process Validation
• Purchasing Controls
• Quality System
• Radiation Sterilization
• Risk Management
• Software Validation
• Statistical Methods
• In-House Training
• Webinars
• Quality System Publications
• Registration

QUICK LINKS

• AAMI Calendar
• Save with Membership —
  US Individual: $205
  Non US Individual: $265

Document Control and Records Management for Medical Devices

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
	Process Architecture Responsibility and Authority
	DAY TWO- 8:00 AM - 5:00 PM
	Electronic Records / Part 11 Document Control and Records Management Production and Process Controls
	DAY THREE - 8:00 AM - 12:00 PM
	Post-Market Controls Change Control and Risk

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.

Dates & Hotels

DATE LOCATION PHONE & RATES April 13-15 , 2010 The Ritz-Carlton, New Orleans 921 Canal Street New Orleans, LA 70112 Website 800-826-897 / 504-524-1331 $199 single / double reservation ID: AAMI rate through March 9, 2010 October 25-27, 2010 The Phoenician 6000 East Camelback Road Scottsdale, AZ 85251 Website 800-888-8234 / 480-941-8200 $199 single / double reservation ID: AAMI rate through September 27, 2010 NOTE: Reservation requests should be made as soon as possible, but no later than the "rate through" date listed above. Rooms are assigned on a first-come, first-served basis and may sell out prior to the deadline.

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.

Fees and Registration
Fees include participant notebook of course materials and case studies; relevant standards and technical information reports; pertinent FDA documents and additional references; and continental breakfast, lunch, and refreshments. Click here to go to registration.

REGISTRATION TYPE 2010 FEES AAMI Corporate & Institutional Member $1685 AAMI Individual Member $1785 Nonmember $2085 Government Employee $585

RETURN TO TOP