Combination Products: Understand and Implement the Requirements
Friday, June 14, 2013 – 11:00 am –1:00 pm Eastern
The goals of this webinar are to:
- Explain and summarize the regulatory requirements for combination products
- Describe the broad range of products considered combination products
- Identify gaps in the existing quality system to meet 21 CFR 4 requirements
- Apply the FDA “streamlined approach” to the existing approach in your company
- Bridge the gap between requirements coming from 21 CFR 210 & 211 versus a 21 CFR 820 based quality system
Speakers
- Anna Lundén, Founder and Training Manager, Key2Compliance AB, Lidingoe, Sweden
- Philippe Joly, Founder, e@sy GMP, Arlington, MA
Who Should Attend?
This program is designed for medical device professionals who are responsible for design and/or engineering, quality systems compliance, risk assessment, assurance, or management for manufacturers that are developing or manufacturing combination products.
Webinar Fees
WEBINAR - Invite your staff and co-workers to listen in for one low price!
- $315 per registration (AAMI Member)
- $415 per registration (Non-member)
Please note: Your registration entitles you to one telephone connection and one computer connection at one physical location. You also have permission to make copies of the written materials for anyone else at your location who might be listening to the program with you. Any transmission, retransmission, or republishing of the audio or web portion of this program is strictly prohibited. International registrants may incur additional phone charges
WEBINAR CD - Includes pdf of handout materials and webinar recording on CD. Please note that the CD will be available three weeks after the program.
- $295 for webinar registrants
- $395 for non-registrants
- domestic and international shipping rates apply
CANCELLATION: Written requests for cancellation may be made to AAMI’s Customer Service Center until May 31, 2013. Registrants will receive a full refund, minus a $50 cancellation fee. No refunds will be provided after May 31, 2013.
Four Ways to Register
- Online - Register Online!
- Phone - +1-800-373-3174 or +1-240-646-7031 to order with a credit card.
- Fax - Select and download the registration form and fax to +1-240-396-5781.
- Mail - Select and download the registration form and mail with payment to:
AAMI Webinar Registration
PO Box 0211
Annapolis Junction, MD 20701-0211
All registrations must be prepaid and in U.S. dollars.
Questions?
All registration questions, please contact AAMI's Customer Service Center at +1-800-373-3174. For content or format questions, please contact Emilee Hughes at +1-703-253-8278.