FDAnews Announces — The New Normal: 3D Printing and Digital Manufacturing Webinar, Aug. 16, 2016
Falls Church, VA (PRWEB) July 25, 2016 -- The New Normal — 3D Printing and Digital Manufacturing:
Making Sense of New FDA Guidance and Product Liability
**An FDAnews Webinar**
Aug. 16, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/3dprinting
The FDA recently issued its first guidance on additive manufacturing — 3D printing — covering, first, the designing and manufacturing of the devices and, second, the testing of the devices.
What can digital manufacturers expect going forward?
Join Mark Carlisle Levy — litigator and trial attorney at Eckert Seamons — for a 90-minute webinar on Aug. 16 where he will discuss what the FDA’s May 2016 Draft Guidance means to manufacturers.
After this webinar attendees will know:
• How the draft guidance addresses the design process and how to strategically plan the next venture in 3D printing.
• How to identify and document manufacturing tolerances to stay in compliance and to maintain records necessary for approval.
• How to address patient-matched designs that interface with existing medical imaging techniques, in a way that enhances, rather than disrupts current manufacturing processes.
• How to deal with a myriad of software issues involved in the conversion of device design into a printable format.
• What the guidance specifically says about material controls, documentation of starting materials, and additives that could be critical in achieving bottom line success.
• What the agency really is requesting in terms of post-processing issues and appropriate documentation.
• What to expect going forward in terms of 3D approval.
• How to address critical risk management and product liability issues.
Register today and gain an analytical understanding of the current 3D printing draft guidance.
Meet the Presenter:
Mark Carlisle Levy, Esq., Member, Eckert Seamons
Mark Levy has represented Fortune 500 companies in complex commercial litigation in state and federal forums across the country. He has spent most of his career defending pharmaceutical and medical device companies, defense contractors, transportation companies, and manufacturers of products in heavily-regulated industries in claims made by federal, state, and local law enforcement agencies.
Who Will Benefit:
• Quality Managers
• Quality Engineers
• Quality Auditors
• Regulatory Managers
• Design & Development Managers
• Design Engineers
• Production Managers
• Production Supervisors
• Manufacturing engineers
• Members of the transition team
Webinar Details:
The New Normal — 3D Printing and Digital Manufacturing:
Making Sense of New FDA Guidance and Product Liability
Aug. 16, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/3dprinting
Tuition:
$287 per site
Easy Ways to Register:
Online: http://www.fdanews.com/3dprinting
By phone: 888-838-5578 or 703-538-7600
About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
Michelle Butler, FDANEWS, http://www.fdanews.com, +1 (703) 538-7665, [email protected]
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