Design Control for Medical Devices
Meeting FDA’s 21 CFR 820.30 Rules for Quality Design and Manufacturing

 

2 day course (8:30 a.m. - 5:30 p.m.)

 

 Get Your Training Direct from Former FDA Device Officials

 Learn straight from the source – former FDA inspectors, rulemakers, and trainers
 from the global consulting team of EduQuest.

 

      -  March 18-19, 2010, Las Vegas, NV

      -  September 21-22, 2010, Wilmington, DE

 

 Design control is required for all medical devices sold in the U.S., EU, Japan, and several

 Other countries.  In addition, there’s relentless pressure from both FDA and Congress to

 improve device design control and manufacturing.

 By registering for this two-day Design Control course, you will:
 

  • Learn how FDA expects you to develop, implement, and manage design control
  • Focus on overcoming one of the biggest obstacles that confounds device
    companies – accurate and consistent transfer of product design to actual
    manufacturing operations
  • Discover how FDA’s design control rules relate to product standards
    established in ISO 9001:2000 and ISO 13485

 Your EduQuest instructors are former FDA investigators, including the founding editor

 and co-author of the FDA’s “bible” for inspectors, the Investigations Operation Manual (IOM),

 as well as experts from the regulated community.

 

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 Course Content:

·         Why does FDA Require Design Controls?

o    FDA’s major areas of concern

o    CRDH’s cradle-to-grave vision: The Total Product Life Cycle

o    Design control as part of the Quality System Regulation (QSR)

o    FDA’s definition of key design terminology

 

·         FDA Guidance for Design Control

o    Defining a “substantially equivalent” production unit

o    Understanding difference between a deviation vs. nonconformance

o    Understanding difference between project design vs. product design

o    How international standards relate to FDA’s expectations

 

·         Design and Development Planning – 21 CFR 820.30 (b)

o    Implementing top-level design control procedures

o    Elements of the General Development Plan (GDP)

o    Best practices in design planning

 

·         Design Review – 21 CFR 820.30 (e)

o    Types of review

o    Proven design review methods

  

·         Design Input – 21 CFR 820.30 (c)

o    Understanding inputs vs. outputs

o    Typical input documents

o    Using FDA recognized standards and guidance

o    Importance of Human Factor considerations

o    Good and bad examples of requirements

 

·         Design Output – 21 CFR 820.30 (d)

o    Process control outputs

o    Other final output documents

o    Conducting design output review

 

·         Design Verification – 21 CFR 820.30 (f)

o    Verification documents

o    Understanding difference between verification vs. validation

o    Elements of a test protocol

o    What FDA looks for in test reports

o    What if the design fails V&V?

 

·         Design Validation – 21 CFR 820.30 (g)

o    How FDA defines validation

o    Key validation documents and methods

o    Conducting design validation review

 

·         Design Change – 21 CFR 820.30 (i)

o    Developing a change control policy

o    Role of planned, temporary changes

o    Identifying all areas impacted by change

o    Conducting re-verification and re-validation

 

·         Design Transfer to Manufacturing – 21 CFR 820.30 (h)

o    Integrating manufacturing considerations into design

o    Key design transfer documents

o    Developing a manufacturing/transfer plan

o    Proven design transfer methods

 

·         Lessons learned in Design Transfer

o    Documentation reminders

o    Impacts on tooling and components

o    Conducting design transfer review

o    Importance of process control review

 

·         Design History File (DHF’s) – 21 CFR 820.30 (j)

o    FDA requirements for design history

o    Responsibilities of team leaders

o    Relationship between the DHF and the Device Master Record (DMR)

o    Creating a traceable DHF index

o    Practical suggestions maintaining compliance

 

 To Register or Get More Details:

 Email Cece Bland, Director of Training and Information Services,

 at Info@EduQuest.net or call +1 (301) 874-6031. Tuition is $1980.

 

 

                         Three-Day Device Compliance Learning Package:

                              Save by Attending Back-to-Back Courses

 

 Immediately before this Design Control course, EduQuest will offer at each location a

 one-day course on QSR Fundamentals: Complying with FDA’s Medical Device 21

 CFR 820 Quality Systems Regulation.

 

 Save $175 when you attend both courses.  The combined tuition is just $2795, including

 three full days of hands-on-training, all course materials, lunch, refreshments, and the

 opportunity to learn and interact with some of the top FDA compliance experts in the nation.

 

 

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