3D Printing for Manufacturing Regulated Products: FDA’s Current Acceptance and Future Projections

Date: February 7, 2025
Duration: 60 Minutes
Time: 12 PM EST

3D printing offers the promise of easy and convenient custom manufacture of a variety of products. There have been several developments in the use of this technology to manufacture medical devices and even attempts to manufacture biologics and drugs. However, there is no clear direction from FDA regarding the approvability of products manufactured using 3D printing technology. There are some precedent regulatory paradigms available to understand what FDA may consider when regulating 3D printed products. This seminar will discuss practical strategic considerations when developing 3D printing technology for FDA-regulated products in the current regulatory environment and some tips on what to expect in the near and far future. Attendees will get an overview of applicable regulations and case studies to emphasize practical challenges and potential solutions for developing medical devices, biologics and drugs using this technology. GMP and QSR considerations for medical devices, biologics and drugs manufactured using 3D printing technology will be discussed.

Why should you attend:
The seminar will discuss the current available regulatory pathways to developing FDA-regulated 3D printed products and predictions on what to expect in the near future. Developers of 3D printing technology will benefit from the discussion on current available regulatory pathways for such products and what to expect in the future. 3D printing in personalized treatments will be discussed and attendees will be provided practical tips for pursuing approval with the FDA.

Areas Covered in the Session:

3D printing technology for medical products
Pros and cons of 3D printing technology for medical products
GMP and QSR considerations for 3D printing
Non-clinical and clinical testing requirements for 3D printing technologies
3D printing and personalized treatments
Recent trends in FDA involvement in 3D printed products
Recent discussions about 3D printing and FDA-regulated products

Who will benefit:
The following individuals or disciplines will benefit from attending this Webinar:

Research and development personnel involved in 3D printed products
GMP and QSR personnel
Regulatory affairs personnel
Senior executives of pharmaceutical and device firms planning 3D printed products
Vice presidents, Directors and Managers
People investing in 3D printing companies

Speaker: Mukesh Kumar

PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.

Webinar Fee

Single Registration

$199

Group Registration (5 Persons)

$699

Group Registration (10 Persons)

$1199

Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.

Terms & Conditions to register for the Webinar

Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com

Payment

We accept credit card, debit card, and PayPal.

Cancellations & Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.

Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.

In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.