One of the biggest concerns facing patient care facility managers today is the recent increase in FDA activity taking place across the country. It is important for the entire profession to be aware of the FDA’s role as it relates to the O&P field and specifically how to prepare your business for compliance with FDA regulations. Failure to comply may result in penalties ranging from severe fines to product recall.
On February 24, the American Orthotic and Prosthetic Association (AOPA) will host a one day seminar, featuring outside experts, geared to address the needs of patient care facilities, manufacturers and distributors. The Seminar is designed to help attending individuals understand the role of the FDA within the O & P field, as well as the regulatory requirements that apply based on the operations the business is involved in.
Attendees will learn about key topics such as:
. What FDA regulations apply to your business . Tips and techniques to ensure your business complies with FDA requirements and is not subject to penalties . Good Manufacturing Practices: Keys to Compliance
. How to prepare in advance for an FDA inspection . What to do when an FDA investigator calls on your business . Medical Device Reporting . Custom prosthetics and orthotics: any exemption as “Custom Devices” under the FDA . New initiatives in the 510(k) process . FDA’s future Unique Device Identification rule
Don’t miss out on this opportunity to learn from FDA experts what you need to do to protect your business!
When: Friday, February 24, 8:30 AM to 5:00 PM
Where: Sheraton Inner Harbor Hotel, 300 South Charles Street, Baltimore, MD 21201. Online Registration is available at: https://aopa.wufoo.com/forms/2012-fda-compliance-workshop-baltimore/
Hotel reservations may be made by calling (410) 962-8300 or online at www.sheratoninnerharbor.com.
For more information contact AOPA Headquarters at [email protected], (571) 431-0876 or visit www.AOPAnet.org.
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American Orthotic and Prosthetic Association (AOPA)
330 John Carlyle Street, Suite 200 Alexandria, VA 22314
Phone: (571) 431-0876, Fax:(571) 431-0899
Email: [email protected]
www.AOPAnet.org
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In the words of Benjamin Franklin, “By failing to prepare, you are preparing to fail.”
