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

  • Speaker:Dr. David Lim
  • Date: 27th September 2018 10:00 AM PST | 01:00 PM EST
  • Duration:90Min
  • Product Code:GRC-90402

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 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 market for medical devices including in Vitro diagnostic medical devices (IVDs).  The 510(k) premarket submission is made to US FDA to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device(s) (predicate device) as described in 21 CFR 807.92(a)(3).  In other words, firms must demonstrate that a proposed product is substantially equivalent to another, a legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA). Over time, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process.

To expedite the process of bringing a product to market through the 510(k) program, it is imperative that the medical device manufacturers understand how to expedite the FDA review process leading to a prompt clearance in view of recent trends and customized strategy for a successful clearance. This presentation is intended to demonstrate how to improve submission quality, which will subsequently prevent avoidable delays and reduce review times.

Areas we will be Covering: 

  • Statute(s) and Regulations
  • Definitions
  • Medical Device Classification
  • 510(k) Process
  • Selecting Predicate Device(s)
  • De Novo Process – Practical Advice
  • How To Demonstrate Substantial Equivalence
  • 510(K) Contents And Format
  • Addressing Technical And Regulatory Requirements.
  • 510(k) Submission Quality For A Product-Be Aware.
  • Responding to FDA’s Request Of Additional Information.
  • Resolving Different Opinions Between The Submitter And FDA Reviewer(S).
  • Avoiding Common Mistakes with Awareness
  • 510(k) Trends
  • 510(k) Preparation: Dos and Don’ts for Best Practices
  • Speaker’s PASS-IT Recommendations

This webinar will be valuable for anyone in the FDA-regulated industry including, but not limited to, medical device, drugs, biologic and in Vitro diagnostic devices. It is particularly useful for those who are engaged in the design and development of medical devices, combinations products (e.g., drug and devices, biologic and devices), and in Vitro diagnostic devices including companion medical products. This webinar is a must for those who are directly or indirectly involved in handling 510(k) regulatory submissions to the FDA.

Who will benefit:

  • Personnel involved in regulatory affairs (associates, specialists, managers, and directors).
  • Personnel involved in clinical affairs (associates, specialists, coordinators, managers and directors)
  • Personnel involved in quality assurance, quality control and quality systems (associates, specialists, engineers, managers, and directors)
  • Personnel involved in research and development (associates, scientists, managers, and directors)
  • Site managers, and consultants
  • Other interested stakeholders (upper management personnel)  

Instructor Profile:

Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor.  As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings.  Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspection observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. 

Available Options

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

$189

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

$279

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

$259

CD-DVD: Shipped within 2 working days

$359

USB - Shipped within 2 working days

$389

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

$289

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

$389

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

$409

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

$539

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

$839

Related Products

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

Implementing a (UDI) Unique Device Identification System

Implementing a (UDI) Unique Device Identification System

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 discuss the regulatory and compliance requirements to implement a system for Unique Device Identification (UDI) including final rules, compliance dates and requirements. The speaker will walk you thro..

$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

How to Prepare Yourself for FDA's on-going Part 11 Inspection Program

How to Prepare Yourself for FDA's on-going Part 11 Inspection Program

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:FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integr..

$279

Validation of Analytical Methods according to the New FDA Guidance

Validation of Analytical Methods according to the New FDA Guidance

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. Certifications: GRCTS Attendance CertificateDescription:FDA has released a new comprehensive guidance for validation of analytical methods. The guidance follows the modern integrated life cycle approach with related new requirements for using quality-by-design components, risk assessment, design..

$269

Comparing GLP with GMP

Comparing GLP with GMP

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:Good Laboratory and Good Manufacturing practices are regulations that are applied during different lifecycle phases of drugs and drug substances. Both regulations have some common requirements but there are also signific..

$269

Quality System Structure and Development for Medical Device Companies

Quality System Structure and Development for Medical Device Companies

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 help you to develop a Quality Management System (QMS) for Medical Device Companies.  A well-structured QMS meets the requirements of the Quality System Regulations and is both effective and efficie..

$249

Understanding the new Revision of USP 1058: Analytical Instrument Qualification

Understanding the new Revision of USP 1058: Analytical Instrument Qualification

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:  The first version of USP <1058> has been released in 2008. Since then it has evolved to the global standard for analytical instrument qualification. In August 2017 a new revision has been released with many n..

$269

What Pharmaceutical Industry Should do to Adequately Implement a Quality Risk Management System

What Pharmaceutical Industry Should do to Adequately Implement a Quality Risk Management System

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 CertificateDescription:This presentation is intended to help you get familiar with best practices for quality risk management (QRM) applicable for pharmaceutical industry (drugs, biosimilars, and b..

$259

How to Best Use Regulatory Pathways: ANDA and 505(b)(2)

How to Best Use Regulatory Pathways: ANDA and 505(b)(2)

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.Description: The United States Food and Drug Administration (FDA) approves news drugs and generic drugs under distinct regulatory pathways covered under Section 505 of the Federal Food, Drug and Cosmetic Act (FDCA or the Act). In this conference, the regulatory pathways, 505(b)2 for NDAs..

$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

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

Auditing Quality Suppliers and Vendors

Auditing Quality Suppliers and Vendors

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:The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking..

$269

Medical Device Design: Dos and Don'ts - Special Considerations

Medical Device Design: Dos and Don'ts - Special Considerations

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:Medical device manufacturers are required to establish and maintain FDA-compliant quality management systems, where appropriate and applicable, including a design control subsystem.  This presentation is intend..

$3269

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

What Medical Device Industry Should Do to Adequately Implement a Quality Risk Management System?

What Medical Device Industry Should Do to Adequately Implement a Quality Risk Management System?

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 presentation is intended to help you get familiar with best practices for quality risk management (QRM) applicable for medical device industry.This seminar is further intended to discuss how quality risk management ..

$4749

Classify Medical Devices In Both The EU (Applying The New EU Regulation) And The US

Classify Medical Devices In Both The EU (Applying The New EU Regulation) And The US

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:The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types ..

$269

Regulations for Advertising Cannabis in the USA,

Regulations for Advertising Cannabis in the USA,

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 Certification of CompletionDescription: Although Cannabis use is illegal at the federal level and although there are only nine states where sale and possession of cannabis is legal for both medical and recreation..

$249

Medical Device Recalls – A Complete Prevention Strategy

Medical Device Recalls – A Complete Prevention Strategy

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. Topic Description:In a recent study, the FDA has reported a 95% increase in medical device recalls over a nine year period ending in 2017 attributable to a variety of reasons.  Whatever the reason, medical device recalls are ex..

$259

Moving from the GMPs to the Pharmaceutical Quality System

Moving from the GMPs to the Pharmaceutical Quality System

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 Certificate.Topic Background:Since the turn of the century, the FDA has been promoting the idea of a Pharmaceutical Quality System.  This is supported by an FDA Guidance Document: Guidance ..

$2649

Preventing Human Error in the Life Sciences

Preventing Human Error in the Life Sciences

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 CertificateBackground:       This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human ..

$269

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

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

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 CertificateTopic 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 compan..

$259

Mitigate Fiscal Risks in Clinical Trials: Coverage Analysis, Budgeting and Billing Compliance.

Mitigate Fiscal Risks in Clinical Trials: Coverage Analysis, Budgeting and Billing Compliance.

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. Background:      This webinar is an integrative learning experience, combining a comprehensive review of the good clinical practice core principles and projec..

$259

Medical Device Risk Analysis in the Design Process

Medical Device Risk Analysis in the Design 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 Attendance CertificateBackground:Medical Devices by their very nature must be safe for human use and must meet the requirements for which they have been designed.  The process which identifies the risks ..

$2659