Learning Design Controls through review of FDA 483 Observations

Instructor: Mercedes Massana
Product ID: 704805
Training Level: Intermediate
  • Duration: 75 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

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Read Frequently Asked Questions

This webinar will provide participants with key knowledge of medical device design controls by analyzing FDA 483 observations and learning what the agency is looking for with respect to each design control element.

Why Should You Attend:

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 and been cited FDA 483 observations for, so that these same mistakes can avoided. Breaking down FDA 483 observations yields a trove of information as to what is important to FDA that medical device manufacturers are not doing correctly.

Areas Covered in the Webinar:

  • Design and Development Planning
  • Design Inputs
  • Design Output
  • Design Reviews
  • Design Verification
  • Design Validation
  • Design Transfer
  • Risk Management

Who Will Benefit:

The following professionals from medical device start-ups and small to medium size device companies will benefit from this training:

  • Quality Assurance Engineers
  • Developers
  • Systems Engineers
  • Quality Auditors
  • Engineering Managers
  • Documentation specialists
  • Manufacturing Engineers

Instructor Profile:

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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