SME’s Quality Processes & Regulatory Considerations for Metal AM seminar will take place at the Sheraton Suites Philadelphia Airport on Tuesday, October 23. Both medical and aerospace manufacturing operate in highly regulated environments. Their use of metal additive manufacturing creates a need to understand how existing regulations, standards, and specifications can be applied. This program brings together those who have worked through the process to share the best information available to help you verify, validate, and meet regulatory requirements. The program will include:
- Quality systems
- Process validation
- Design controls
- Regulatory agencies perspectives
- Standards for metal additive manufacturing
- Roundtable discussions
- And more!
- Gain insight into FDA’s view of 3D Printing as applied to medical devices and FAA’s perspective for aerospace
- Obtain an overview of the types of applications already in use
- Understand how quality, controls, validation and verification can be accomplished
- Learn the latest available information on regulatory processes specific to additive manufacturing
- Meet and discuss processes with others facing similar challenges.
- Have your specific questions answered and problems solved by industry experts.
- Network with participants during a reception at the end of the day.
- Co-located with Metal Additive Manufacturing Developments, October 24
8:30 AM – 8:45 AM
Introduction / Background
Lauralyn McDaniel, SME
8:45 AM – 9:35 AM
FOUNDATION: Quality System, Design Control, Validation and Verification (with practical applications examples)
Kim Torluemke & Ryan Kircher; 3D Systems
9:35 AM – 10:05 AM
Dan Fritzinger, DePuy Synthes
10:05 AM – 10:20 AM
10:20 AM – 10:50 AM
FDA’s Perspective on 3D Printing for Medical Devices
Matthew DiPrima, FDA
10:50 AM – 11:20 AM
FAA’s Perspective on Additive Manufacturing for Aerospace
11:20 AM – 11:50 AM
Process Validation (with practical applications examples)
Dan Fritzinger, DePuy Synthese
11:50 AM – 12:50 PM
12:50 PM – 1:20 PM
Global Regulation Strategies for Medical Additive Manufacturing
Beatrice Ogembo, American preclinical Services
1:20 PM – 1:50 PM
Global Regulation Strategies for AM Aerospace
1:50 PM – 2:10 PM
2:10 PM – 2:40 PM
Standards for Metal AM – Current State, Work Items, and Gaps
Lauralyn McDaniel, SME
2:40 PM – 4:15 PM
Round Table Discussions – Diving into the details!
4:15 PM – 4:30 PM
Wrap-Up & Questions/Answers
4:30 PM – 6:30 PM
Networking Reception with Tabletop Displays
Interested in having a tabletop display? Complete form here and additional information will be sent to you.
Sheraton Suites Philadelphia Airport
4101B Island Avenue
Philadelphia, PA 19153
SME has negotiated a discounted rate for attendees of this seminar. Book your hotel room here.
Group Rate: $149
Cutoff Date: October 8, 2018
Group Name: SME Metal Additive Mfg
*Complimentary WiFi in guest rooms
*$8 per day parking
*Complimentary shuttle to/from Philadelphia International Airport
Attend BOTH this program and Metal Additive Manufacturing Developments and save 20% – SME Members and Non-Members Only.
|Pricing||SME Members||Non-Members||Academia Government/Military*|
(15% discount as shown below)
Member / Non-Member
(50% discount as shown below)
Member / Non-Member
|One Seminar||$595||$695||$505.75 / $590.75||$297.50 / $347.50|
|Two Seminars||$476 (each)||$556 (each)||$505.75 / $590.75 (each)||$297.50 / $347.50 (each)|
*Academic, Military & Government Pricing: To qualify for the reduced rate you must submit a letter on appropriate military/government letterhead signed by your Commanding Officer or supervisor to the SME Registrar. Educators may submit either a letter on university letterhead signed by the dean or registrar confirming status or a class schedule inclusive of the institution/year/instructor.
**Full-Time Students: To qualify for student rates, submit a letter on university letterhead signed by the dean or registrar confirming full-time student status or provide a copy of your student I.D. to the SME Registrar.
Interested in sponsoring or speaking at the event? Contact Lauralyn McDaniel, at 800.733.3976 ext. 3108 or firstname.lastname@example.org.