FDA PMA (PreMarket Approval)

  • Speaker:Grace Powers
  • Duration:60Min
  • Product Code:GRC-NR22

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  • Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you don’t receive an email within 6 days. Please email our support@grcts.com

Recorded Session - How it works

  • Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
  • Please click on the link to access the Recording and type in the password provided in the email.
  • Presentation and other handouts will be emailed to you in a pdf format.

Training CD - How it works

  • Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.

(For more information about our products contact +1- 248-233-2049)

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the Recording of the Training for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. 

Certifications: GRCTS Attendance Certificate

Topic description: 

This webinar will discuss all aspects of the US FDA PMA(Premarket approval) process.  This webinar will review what types of products require a PMA.  It will include a review of the types of PMAs- traditional and modular.  Also, the content of a PMA will be discussed.  The webinar will include an overview of the post-market submission requirements for PMAs such as 30-day notices, supplements, real time reviews, etc.  This webinar will provide an overview of the entire PMA process. 

Learning Objectives:

  • Understand the USA FDA PMA process
  • Understand the types of PMA submissions
  • Understand the types of Post-Market PMA submissions
  • Understand the various types of FDA meetings
  • Understand the logistics of an in-person FDA meeting
  • PMA Annual Reports
  • PMA 30-day change notices
  • PMA Real Time Review
  • PMA Supplements

Areas we will be discussing: 

  • What is a PMA? 
  • When is a PMA required for my product? 
  • What information is required in a PMA? 
  • Once my PMA is approved what types of product changes require additional approval? 

Audience: 

Anyone from small or large companies looking to submit a Pre-Submission

  • Inventors
  • Innovators
  • CEOs
  • CMOs
  • VPs
  • Compliance Officers
  • Regulatory Affairs - all levels
  • Clinical Affairs - all levels
  • Quality Assurance - all levels
  • Quality Engineering - all levels 
  • Medical Scientists
  • R&D - all levels
  • Consultants
  • Contractors/Subcontractors
  • Anyone interested in the FDA PMA process

Instructor: 

Grace Powers is an independent regulatory affairs consultant. She founded Powers Regulatory Consulting in 2015 to help clients with regulatory strategies and submissions. Her clients have included universities, investors, start-ups and mid-size medical device companies. She has fifteen years of industry experience in medical devices including research and development. She has previously worked at Brookhaven Medical, Bard Medical, CardioMEMS and Novoste, all in the Atlanta area.

She has leadership experience with managing regulatory affairs responsibilities related to all pre- and post- marketing regulatory activities and submissions. Her RA submission experience includes 510(k), Pre-Submissions, IDE, PMA, EU Technical Files and Design Dossiers. She has also managed an International RA team which including Canadian licensing, TGA, Japan, China, Russia, Latin America and other country submissions. Grace holds an BE in Biomedical Engineering from Vanderbilt University, an MS in Biomedical Engineering from UCLA and an MBA from Georgia Tech. She is RAC US, RAC Europe, and RAC Global certified.

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Available Options

Recording: Unlimited Viewing Access for 6 Months

$429

CD-DVD: Shipped within 2 working days

$479

USB - Shipped within 2 working days

$489

5 Member Group: 5 people can Attend the Live Online Meeting from any location globally

$899

10 Member Group: 10 people can Attend the Live Online Meeting from any location globally

$1,659

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