ComplianceOnline

Learning Design Controls through review of FDA 483 Observations

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

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Sep-2016

Training CD / USB Drive

$349.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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