US FDA Pre-Submission process, IDE, 510(k), PMA and IVD

  • Speaker:Grace Powers
  • Date: 14th January 2019 10:00 AM PST | 01:00 PM EST
  • Duration:60Min
  • Product Code:GRC-90521

$155

29

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 Pre-Submission process.  This webinar will review when a Pre-submission may be appropriate for a company or product.  It will include a review of the guidance document.  The types of Pre-submissions will also be reviewed including those for IDE applications, study risk determinations, Pre-Sub for a 510(k), Pre-Sub for a PMA and Pre-Sub for an IVD.  The content needs for the various Pre-Sub types will also be explored.  Questions that are appropriate for FDA Pre-Submissions will be discussed in great detail including examples of good and not so good questions for FDA.  The e-copy required for Pre-Submissions will be reviewed as well as tips of the logistics of in person meetings at FDA.  Overall the webinar will include the all the background needed to submit a Pre-Submission. 

Learning Objectives:

  • Understand the USA FDA Pre-submission process
  • Understand the types of Pre-Subs
  • Understand the various types of FDA meetings
  • Understand the logistics of an in-person FDA meeting
  • Pre-Sub for a 510(k)
  • Pre-Sub for a PMA
  • Pre-Sub for an IVD
  • Areas Covered:
  • What is a Pre-Submission? 
  • When is a Pre-Submission appropriate for my company or product? 
  • What types of questions are right to ask for FDA Pre-Submissions
  • Complete Background and Preparation required to submit Pre-Submissions
  • How will I get my feedback?

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 Pre-submission 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

$155

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

$275

Recording: 6 Months Access to the Training which can be accessed from any location

$235

CD-DVD: Shipped within 2 working days

$335

USB - Shipped within 2 working days

$365

Live + Recording: Attend Live Meeting Online + Access the recording for 6 months

$285

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

$385

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

$405

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

$565

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

$865

Related Products

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.  USE COUPON “GRCTS10” TO AVAIL A 10% DISCOUNT Description: Excel Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulatio..

$235

Understanding the US FDA Drug Review and Approval Process

Understanding the US FDA Drug Review and Approval Process

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. Certification: GRCTS Completion CertificateWhy you must attend: The FDA’s Center for Drug Evaluation and Research (CDER) is responsible for reviewing and approving both prescription and nonprescription or over-the-counter (OTC) ..

$259

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

Complaint Handling and Medical Device Reporting

Complaint Handling and Medical Device Reporting

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: Complaint Handling and Medical Device Reporting are considered critical processes by the FDA in maintaining the public safety. Because they are so critical the FDA frequently inspects these areas in great detail. M..

$249

Preparing Compliant eCTD Submissions:  Are you prepared for upcoming FDA mandate on e-submissions?

Preparing Compliant eCTD Submissions: Are you prepared for upcoming FDA mandate on e-submissions?

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.Why You should Attend The Session:This webinar will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD.  Description:The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic p..

$279

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

Qualification of contract manufacturer organizations based on practical experience

Qualification of contract manufacturer organizations based on practical experience

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. Why should you attend:Regulatory agencies require that companies carefully select suppliers and contract manufacturers? The responsibility for product quality and safety remains with the company. It cannot be delegated to the CMODes..

$289

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

Preparation of FDA Submissions and Communicating with the FDA (INDs, NDAs, BLAs, ANDAs, PMAs, 510(k)s, IDEs, Post-Approval Supplements)

Preparation of FDA Submissions and Communicating with the FDA (INDs, NDAs, BLAs, ANDAs, PMAs, 510(k)s, IDEs, Post-Approval Supplements)

Background: Getting a drug, biologic or medical device approved by the FDA is one of the highest hurdles in the development process. This seminar covers current FDA regulatory compliance and the approval process with respect to developing and marketing drugs, biologics and medical devices. A focus will be placed on relevant aspects of FDA regulations and the practical aspects of bringing a medical product to market. The course will initially cover the general context for medical device regu..

$1269

Implementing the Best Practices for FDA Inspection Preparation and Management

Implementing the Best Practices for FDA Inspection Preparation and Management

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. CertificationsGRCTS Attendance CertificateDescription: This seminar will discuss guidelines to adequately implement the best practices for FDA inspection preparation and management compliant with the Good Manufacturing Practices ..

$259

Writing an Effective Standard Operating Procedure (SOPs)

Writing an Effective Standard Operating Procedure (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 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. Use coupon code "GRCTS10" to avail a 10% Discount on your purchaseCertification: GRCTS Attendance CertificateDescription: Standard Operating Procedures (SOPs) are required for companies that are regulated. However, there is ..

$269

Effective Training & Development in the Life Sciences

Effective Training & Development in the Life Sciences

This Training is available for On Site and Corporate TrainingCertification:GRCTS Completion CertificateAbout the topic: Training and documentation within the Life Sciences are inextricably linked together into an integrated system that combines “Best Practices,” regulatory compliance, principles of human performance, and adult learning to achieve the most favorable outcome of superior worker performance and the achievement of compliance excellence.Training is the process by which indivi..

$809

Healthcare Compliance Program Effectiveness: Auditing and Monitoring

Healthcare Compliance Program Effectiveness: Auditing and Monitoring

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.  Description:  This webinar will discuss the best practices of implementing auditing and monitoring as a part of your compliance program. The U.S. Department of Health and Human Services (HHS) Office of Inspector General..

$469

Mobile Medical Apps (is it regulated by FDA) & Cyber-Security

Mobile Medical Apps (is it regulated by FDA) & Cyber-Security

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 how to determine if your app is a medical device and if it will be subject to FDA requirements. The FDA approval process for a new app will be explained including FDA requirements for soft..

$459

Compliance Measures for Case Managers

Compliance Measures for Case Managers

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.  Certification: GRCTS Attendance Certificate Description:  This program will review the compliance issues that most greatly impact your practice such as the 2-midnight rule, the NOTICE Act, HINNs, the important messag..

$429