ComplianceOnline

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

Instructor: Mukesh Kumar
Product ID: 703621
  • Duration: 60 Min

recorded version

$229.00
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Recorded Link and Ref. material will be available in My CO Section

Training CD

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Read Frequently Asked Questions

The webinar will discuss the current available regulatory pathways to develop FDA-regulated 3D printed products and also predictions on what to expect in the near future. 3D printing in personalized treatments will be discussed and attendees will be provided practical tips for pursuing approval with the FDA.

Why Should You Attend:

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.

Despite the wide-spread use and development of 3D printing technology, there is no clear direction from FDA regarding the approval of products manufactured using this technology. There are some precedent regulatory paradigms available to understand what FDA may consider when regulating 3D printed products.

This webinar 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 also be discussed.

Areas Covered in the Webinar:

  • 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:

  • 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
  • 3D printing technology developers

Instructor Profile:

Dr. Mukesh Kumar, is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the regulatory affairs and quality assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about more than 100 clinical trials in more than 40 countries, has made hundreds of US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU, Taiwan, Korea, China, Canada, countries in South America, Australia, and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe, North and South Americas and Asia.

Dr. Kumar has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well-known expert in global regulatory affairs and has been an invited speaker in several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

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