Planning for a Successful Submission
When releasing a new product, it is critical to the financial and competitive success of your company to know how to complete a submission with minimal or no delay. Knowing what type of submission to prepare and how to properly present it will contribute to a successful partnership with FDA. This webinar CD describes the submission process and provides information critical to completing submissions quickly and cost effectively. It also provides an understanding of the common pitfalls and delays — and preventive measures you can take to avoid them.
This two-hour webinar CD gives you an opportunity to hear directly from industry and FDA as well as listen to questions and answers given during the live broadcast.
SPEAKERS
- Annette Hillring, President, Hillring & Associates, Inc.
- Sousan S. Altaie, Ph.D., Scientific Policy Advisor, Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, U.S. Food and Drug Administration (FDA)
- Miriam C. Provost, Ph.D., Deputy Director, Office of Device Evaluation, Center for Devices and Radiological Health, U.S.Food and Drug Administration (FDA)
PROGRAM-AT-A-GLANCE
- Provides an overview of the different types of submissions - PMAs, 510(k)s, and IDEs
- Offers tips on the submission process – strategies for filing and how to avoid delays
- Advises how to communicate with FDA before and during the review process
- Explains the review process and related correspondence
- Discusses what’s new in compliance guidance documents
- Presents an in-depth tutorial on Turbo 510(k)s
WEBINAR CD
- Includes handout material and CD.
- $245 for webinar registrants/$345 for non-registrants
- Please note: domestic and international shipping rates apply.
THREE WAYS TO ORDER
- Phone – 1-877-249-8226 / 240-646-7031 to order with 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:
Submissions Webinar CD Package
AAMI Publications
PO Box 0211
Annapolis Junction, MD 20701-0211
QUESTIONS?
For questions about ordering the CD, please contact AAMI’s Publications at 1-877-249-8226 / 240-646-7031.