FDA PMA (PreMarket Approval)

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

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.

Write a review

Please login or register to review

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

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

Validation and Control of Excel Spreadsheets in Regulated Environments (R)

Validation and Control of Excel Spreadsheets in Regulated Environments (R)

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..

$189

Root Cause Analysis and CAPA (+)

Root Cause Analysis and CAPA (+)

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 Description: Conducting an effective root cause analysis can be a daunting task. And without a good root cause analysis, your CAPA will not result in the desired improvement. This webi..

$169

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. ..

$169

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

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 e..

$189

2 Days - Data Integrity: compliance with 21 CFR Part 11, Annex 11, SaaS/Cloud, and EU GDPR

2 Days - Data Integrity: compliance with 21 CFR Part 11, Annex 11, SaaS/Cloud, and EU GDPR

  This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments. It details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, elec..

$1229

One Day Workshop -  Excel Spreadsheet Validation-Step by Step Guide to Data Integrity Compliance

One Day Workshop - Excel Spreadsheet Validation-Step by Step Guide to Data Integrity Compliance

In this one-day seminar you will learn how to configure Excel applications with the features required for 21 CFR Part 11 thereby helping you to avoid 483s. Using the risk based computer system validation approach you will validate your own Excel application. Use of the validation templates typically saves two thirds of the validation time and costs. This seminar will improve your Excel skills and create a set of validation documents that you can use for subsequent Excel application and other Com..

$745

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, succe..

$189

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..

$229

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 e..

$169

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 o..

$269