3 Hours Virtual Seminar: Learning Design Controls Through Review of FDA 483 Observations

Mercedes Massana

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Meeting design control requirements is essential to the success of any medical device company. For those that need a primer on where to focus their efforts, the best way to learn about design controls is from the mistakes that other companies have made which resulted in cited FDA 483 observations. By learning what not to do, these same mistakes can avoided. Breaking down FDA 483 observations yields a trove of information as to what is important to FDA and what medical device manufacturers are doing wrong.

Course Objective

  • Understand the FDA expectation for each element of design controls.
  • Understand the most likely causes of FDA 483 observations for each element of design control.
  • Breaking down actual FDA 483 and determine key activities to avoid similar observations.
  • Know what you can do to prepare for a Design Control audit.
  • How lack of Design Controls can lead to observations in other QSR areas.

Course Outline

  • Design and Development Planning
  • Design Inputs
  • Design Outputs
  • Design Reviews
  • Design Verification
  • Design Validation
  • Design Transfer
  • Risk Management
  • The language of an FDA 483 Observation

Target Audience

  • Quality System auditors
  • Engineering managers and personnel
  • Regulatory Affairs
  • Product development engineers
  • Systems engineers
  • Quality Engineers

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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Mercedes Massana,

Mercedes Massana, is the founder and CEO of MDM Engineering Consultants, a consulting firm that provides engineering and quality consulting services in the medical device, biotechnology, and pharmaceutical industries. Mercedes has over twenty-five years of experience in the Medical Device industry. Extensive experience in developing processes within the constraints of FDA/lSO Quality Systems. She has been responsible for establishing processes and leading groups of engineering in the following disciplines: Risk Management, Requirements Management, Verification and Validation, Process Improvements, Project Management, Software Systems Validation, Process Validation. Mercedes is an ASQ certified Biomedical Auditor (CBA), Software Quality Engineer (CSQE), Quality Manager (CQMa) and Quality Auditor (CQA). Mercedes is well versed in FDA and ISO regulations.

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