Leading Practice on Compliance Series: Designing the 'Right' Device
The fifth webinar in the Leading Practice series focuses on bringing design inputs down to earth, and communicating them easily for the designer to facilitate creating the device intended use, performance, safety, and reliability characteristics. The outcome will be better design inputs which eventually results in a better device design (21 CFR Part 820.30(c)).
This webinar and its corresponding guidance document will examine how best to ensure the design input process is effective and compliant with the Quality System regulation.
| WHO SHOULD PURCHASE |
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| Instruction is targeted to quality managers, quality auditors, regulatory/compliance professionals, design and development team members, and executive management. |
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| QUESTIONS? | |
For questions about ordering the CD, please contact AAMI publications at 1-877-249-8226 or 240-646-7031. |
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PROGRAM OBJECTIVES
Over the course of one hour, the program will address the FDA Warning Letter citations associated with design input:
- Step 1 – Establishing the Process Requirements
- Step 2 – Establishing the Design Requirements (Design Inputs)
- Step 3 – Verifying the Design Requirements (Design Inputs)
- Step 4 – Maintaining the Design Requirements (Design Inputs)
SPEAKER
- Michael Hoffman, Principal, Hoffman Regulatory and Quality Consulting
WEBINAR CD
- Time: one hour
- Includes pdf of handout materials and webinar recording on CD.
- $50 for webinar registrants
- $75 for non-registrants
- domestic and international shipping rates apply
WAYS TO PURCHASE
- Online - Buy online.
- Phone - 1-877-249-8226 or 240-646-7031 to order with a credit card.
- Fax - Select and download the order form and fax to 240-396-5781.
- Mail - Select and download the order form and mail with payment to:
AAMI Webinar CD
Leading Practice on Compliance Series: Designing the 'Right' Device
PO Box 0211
Annapolis Junction, MD 20701-0211