Post Market Topics for Medical Devices

Once a medical device is commercialized, FDA requirements mandate that a company must perform Post Market Surveillance (PMS) to ensure public safety and efficacy.

This course will provide a detailed training on a variety of Post Market Topics and will introduce professionals to the many typical situations they may be responsible for during the weeks, months and years after commercialization of a product. Learning will be done by studying regulations, investigating the history of other companies (particularly failures), and sharing experiences within the class.

Topics Include:

* Complaint Management
* Failure Investigations
* Recalls
* Internal Audits
* Inspection Management Marketing Material

Practical Skill Development:

* How to manage complaints
* How to decide between a recall or enhancement
* Do’s and Don’ts during an FDA inspection
* Tools used to improve internal audits
* Best Practices for Marketing Materials
* Tools to protect company from off-label promotion

Course Number: BIOL-40326
Credit: 3.00 unit(s)
Related Certificate Programs: Regulatory Affairs for Medical Devices

+ Expand All

9/25/2023 - 12/4/2023

$725

Online

Closed

• SECTION ID:

  176197

• CLASS TYPE:

  Online Asynchronous.
  
  This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
  You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.

• INSTRUCTOR:

  Maroofian, Ray

• TEXTBOOKS:

  No information available at this time.

• POLICIES:

  No refunds after: 10/2/2023.
  

• NOTE:

• DATE & LOCATION:

  9/25/2023 - 12/4/2023
  extensioncanvas.ucsd.edu
  You will have access to your course materials on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.