Understanding US FDA UDI in the Healthcare Industry on 13 May 2016
US FDA has established a unique device identification system to effectively identify medical devices through their distribution and use. The label of most medical devices will include a unique device identifier (UDI) in both human and machine-readable form.
GS1 is one of the FDA-accredited issuing agency that operates a system for assignment of UDIs according to the rule. GS1 Singapore will support our healthcare industry to meet with the FDA's Unique Device Identification (UDI) rule for enhanced patient safety.
Find out how GS1 Standards can comply with US FDA requirements and what manufacturers and brand owners need to do to meet the requirements and timeline.
Key Objectives
- Find out how GS1 Standards can comply with US FDA requirements
- Understand how to meet US FDA requirements and timeline
- Understand different labelling, types of direct part marking and verification procedures
Who should attend?
- Medical Device manufacturers/ brand owners (Individuals in – Quality Assurance/ Quality Control/ Regulatory Compliance)
- Medical device distributors/suppliers
- Hospital, professional associations and institutions
| Time |
Programme Details
|
1.30pm – 2.00pm
|
Registration |
2.00pm – 2.10pm
|
Opening Speech |
GS1 Singapore Limited |
2.10pm – 3.00pm
|
How GS1 Standards Can Comply with US FDA Requirements and Timeline |
GS1 Singapore Limited |
3.00pm – 3.30pm
|
Understanding Print Techniques and Verification for Labels & Direct Part Marking |
Zincode Technologies Pte Ltd |
3.30pm – 4.00pm
|
Sharing of Success Stories |
Zincode Technologies Pte Ltd |
4.00pm – 4.30pm
|
Track and Trace AuthenticateIT Solutions |
AuthenticateIT Singapore Pte Ltd (AIT) |
4.30pm – 5.00pm
|
Networking Session, Free Verification and Demonstration |
Registration
Complete the registration form below; an email confirmation will be sent to your organisation.
All fees are inclusive of 7% GST.
Payment Options:
a. Cheque - Made payable to
'GS1 Singapore Limited'
Address:
2985 Jalan Bukit Merah Singapore 159457
b. Credit Card (
Download Credit Card Authorisation Form)
For any enquiries, please contact us at: 6826 3077 or
contact@gs1.org.sg
Cancellation and Substitutes:
1. We regret there will be no refunds for cancellations, no-shows and non-attendance, replacement of participant is permitted and notice of change in participant’s must be given in writing, not less than 5 business days before the course commencement date.
2. A confirmation note will be sent one week prior to event via email. All registrations will be taken as confirmed and will be billed accordingly (including no-shows) unless otherwise notified.
3. When a seminar is cancelled, fail to commence or fail to complete under unforeseen circumstances, participant is allowed to defer the intake at no cost or withdraw from the course; under such situation, a full refund of the advance payment will be given.
4. GS1 Singapore reserves the right, at our sole discretion, to change, modify or otherwise alter these terms and conditions at any time. Such modifications shall become effective immediately upon the posting thereof.