FDA PMA (PreMarket Approval)

  • Speaker:Grace Powers
  • Date: 18th March 2019 10:00 AM PST | 01:00 PM EST
  • Duration:60Min
  • Product Code:GRC-90543

$89

24

DAYS
Left to Register

Live Session - How it works

  • Username and Password will be sent to you within 24 hours prior to the webinar.
  • Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
  • Login to the session by clicking on “Join the Meeting” in the login instructions and then dial the number to connect to the meeting audio or use your Computer to connect to audio. Please use the name and the email address you used at the time of registration to join the meeting.
  • Get answer to your queries through interactive Q&A sessions. The Q and A sessions are at the end of the meeting. The expert will complete his/ her presentation and then the phone lines will be open for the audience to discuss your questions.
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve our Training programs.
  • 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.

Available Options

Live Meeting Access Single: Attend the Live Meeting Online from any location

$89

2 Single Live Access: 2 people can attend the meeting Live from any location

$129

Recording: Unlimited Viewing Access for 6 Months

$179

CD-DVD: Shipped within 2 working days

$279

USB - Shipped within 2 working days

$289

Live + Recording: Attend Live & Unlimited Viewing Access to Recording for 6 months

$229

Live + CD: Attend Live Meeting Online + Get the training CD shipped for free

$329

Live + USB - Attend Live online + Get the training USB shipped for free

$339

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

$389

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

$649

Related Products

Creation of DHFs, DMRs, and DHRs utilizing the principles of Lean Documents and Lean Configuration

Creation of DHFs, DMRs, and DHRs utilizing the principles of Lean Documents and Lean Configuration

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar 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. Certification: GRCTS Completion Certificate Abbreivations:  DHF - Design History File DMR - Device Master Record DHR - Device History Record Why should you attend: Medical Device managers, engi..

$229

510(K) Submission - A Comprehensive and an Updated Overview

510(K) Submission - A Comprehensive and an Updated Overview

If you are unable to attend the Live meeting then you can opt in for the Live Recording instead. You can access the recording of the webinar for 6 months. Contact our support for any clarifications.  Certifications: GRCTS Attendance Certificate Why should you attend: The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) prescribes the premarket notification requirements. The premarket notification [510(k)] is the most common pathway to mark..

$245

Writing and Enforcing Effective SOPs

Writing and Enforcing Effective SOPs

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar 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.Description: Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another stor..

$269

Validation and Control of Excel Spreadsheets in Regulated Environments

Validation and Control of Excel Spreadsheets in Regulated Environments

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar 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.  Description: Excel Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 2..

$269

U.S. Cosmetic Regulations and New Legislation

U.S. Cosmetic Regulations and New Legislation

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. You can access the recording of the webinar for 6 months. Contact our support for any clarifications.Certification: GRCTS Attendance CertificateDescription: This webinar will cover laws and regulations for successful marketing and compliance of cosmetics in the U.S. It will help clarify what claims and product labeling are appropriate for cosmetics to market them successfully and avoid regulatory ..

$259

Essentials of Validation – IQ, OQ and PQ Protocols

Essentials of Validation – IQ, OQ and PQ Protocols

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar 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 Description: Validation is an important element of the Quality System Regulations and ISO13485.   This course will cover the requirements the essentials of validation. ..

$229

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar 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 -Background:Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful proje..

$259

How to Conduct a Human Factors/ Usability Validation

How to Conduct a Human Factors/ Usability Validation

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar 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.Description:This webinar will explain the procedure described in ISO 62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation. For example, success crite..

$259

21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

The price for the recording is a discounted figure since the recording has a bit of static. The audio of the expert is loud and clear. However, due to static within the meeting. We are obligated to offer the recording at a discounted price. Please contact our support@grcts.com or click on chat below if you have any questions. Why should you attend:If you are constantly struggling to create, manage, and maintain all of the information found in controlled documents, all of which are often red..

$269

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar 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.Background:Test method validation is an often-confusing requirement for medical devices.  A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect.   For example, ..

$269