WebRTC Solutions Industry News

TMCNet:  Global Quality Systems--An Integrated Approach To Improving Medical Product Safety; Public Workshop

[February 13, 2013]

Global Quality Systems--An Integrated Approach To Improving Medical Product Safety; Public Workshop

Feb 13, 2013 (FIND, Inc. via COMTEX) -- SUMMARY: The Food and Drug Administration (FDA) Cincinnati District Office, in cosponsorship with the Association of Food and Drug Officials (AFDO), is announcing a public workshop entitled "Global Quality Systems--An Integrated Approach to Improving Medical Product Safety." This 2-day public workshop is intended to provide information about FDA drug and device regulation to the regulated industry.

DATES: The public workshop will be held on June 10 and 11, 2013, from 8 a.m. to 5 p.m.

ADDRESSES: The public workshop will be held at the Louisville Marriott Downtown, 280 West Jefferson St., Louisville, KY, 502-627-5045 or toll-free 800-533-0127; http://www.marriottlouisville.com/.

Attendees are responsible for their own accommodations. To make reservations at the Louisville Marriott Downtown, at the reduced conference rate, contact the Louisville Marriott Downtown before May 2, 2013, and cite meeting code "AFDO Conference." FOR FURTHER INFORMATION CONTACT: Krystal Reed, Association of Food and Drug Officials, 2550 Kingston Rd., suite 311, York, PA 17402, 717-757-2888, FAX: 717-650-3650, email: kreed@afdo.org.

SUPPLEMENTARY INFORMATION: Registration: You are encouraged to register by May 14, 2013. The AFDO registration fees cover the cost of facilities, materials, and breaks. Seats are limited; therefore, please submit your registration as soon as possible. Course space will be filled in order of receipt of registration. Those accepted into the course will receive confirmation. Registration will close after the course is filled. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop beginning at 7:30 a.m. The cost of registration is as follows: Cost of Registration Member $450.00 Non-Member $550.00 To be added to registration fee for registration postmarked after $100.00 May 14, 2013 If you need special accommodations due to a disability, please contact Krystal Reed (see FOR FURTHER INFORMATION CONTACT) at least 21 days in advance of the workshop.

Registration instructions: To register, please complete and submit an AFDO Conference Registration Form, along with a check or money order payable to "AFDO." Please mail your completed registration form and payment to: AFDO, 2550 Kingston Rd., suite 311, York, PA 17402. To register online, please visit http://www.afdo.org/conference. (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register .) The registrar will also accept payment through Visa and MasterCard credit cards. For more information on the public workshop, or for questions about registration, please contact AFDO at 717-757-2888, FAX: 717-650-3650, or email: afdo@afdo.org The public workshop helps fulfill the Department of Health and Human Services' and FDA's important mission to protect the public health. The workshop will provide FDA-regulated drug and device entities with information on a number of topics concerning FDA requirements related to the production and marketing of drugs and/or devices. Topics for discussion include the following: . Future of Combination Product Regulation.

. Unique Device Identifier Progress.

. Health Canada Update.

. The Safety of our Drugs and Devices--the Complex Reality.

. Nanotechnology.

. Drug and Medical Device Trends.

. Case for Quality (Center for Devices and Radiological Health) Presented by Steve Silverman.

. Working Luncheon Interactive Session--Lessons Learned From the Mistakes of Others.

. Complaint Handling--It's Not Just About Compliance--It's an Effective Business Driver.

. FDA's Cosmetic Regulatory Agenda.

. Challenges With Implementation of U.S.P. 35 on a Global Basis.

. Pilot Program for Abbreviated Drug Inspections.

FDA has made education of the drug and device manufacturing community a high priority to help ensure the quality of FDA-regulated drugs and devices. The workshop helps to achieve objectives set forth in section 406 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) (21 U.S.C. 393), which includes working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. The workshop also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), as outreach activities by Government Agencies to small businesses.

Dated: February 8, 2013.

Leslie Kux, Assistant Commissioner for Policy.

[FR Doc. 2013-03323 Filed 2-12-13; 8:45 am] BILLING CODE 4160-01-P Vol. 78, No. 030 [Docket No. FDA-2013-N-0001] Notices

[ Back To WebRTC Solutions's Homepage ]

FOLLOW US

Featured Podcasts

Oracle in Enterprise Communications

Most in the industry have heard of the acquisition of Acme Packet by Oracle. What you may not know is that Oracle has a number of telecommunications products including a UC suite, WebRTC Session Controller, and Operations monitoring tools. Oracle is pursuing both the enterprise and service provider.

Featured Whitepapers

WebRTC Security Concerns

This whitepaper covers two of the most relevant topics in communications industry today: WebRTC and security. We will introduce the problem of security in WebRTC including those traditional VoIP attacks that are going to be present in WebRTC services. Later we will mention ad-hoc WebRTC attacks and protection mechanisms, to close with an overview of identity management solutions.

Migrating Real Time Communications Services to the Web

In the Internet age, businesses that own fixed and mobile communication networks, including traditional Communications Service Providers (CSPs) of all kinds, are being challenged with some tough questions: How do we stay relevant to our customers?

Delivering Enterprise-Class Communications with WebRTC

WebRTC is an emerging industry standard for enabling Web browsers with real-time communications capabilities. It enables enterprises to enhance Web sites, empower BYOD users, and improve video collaboration and on-line meetings, to name but a few examples.

WebRTC Report Extract Reprint

This document examines the growing important of WebRTC, both generally and for telecom service providers. It considers the expanding range of use-cases, the multiple layers of interoperability likely to be desired by telcos, and some implications in terms of network integration and mobility.

WEBRTC SOLUTIONS PAPERS, SLIDES, COLLATERAL

Robust Enterprise Grade WebRTC Systems and Services


The emerging WebRTC standard has become one of the industry's hottest topics – and with good reason. Being able to "communications enable the web" has Communications Service Providers as well as Enterprises busily making plans for deployment. But, as these plans unfold, reality is starting to intrude on those plans. Our expectations of telephony services are much higher than web browsing. We expect the phone to connect instantly, operate with minimal disruption, and work seamless across any network, anywhere, at any time. There is also an understanding that phone service is inherently secure. With WebRTC, the expectation is for these applications to behave in the same manner.

This session looks at the user experience and expectations of a WebRTC Enterprise service. It will also cover how a WebRTC enterprise handles security, reliability, and interoperability within browsers and networks.

ORACLE COMMUNICATIONS WEBRTC SESSION CONTROLLER

The Oracle Communications WebRTC Session Controller enables communications service providers (CSPs) and enterprises to offer WebRTC services – from virtually any device, across virtually any network – with carrier-grade reliability and security.

Sales Presentation: Oracle Communications WebRTC Session Controller

Agenda:
- WebRTC Market and Opportunities
- WebRTC Challenges
- Oracle Communication WebRTC Session   Controller
- Summary

ORACLE COMMUNICATIONS WEBRTC SESSION CONTROLLER SOLUTION

Communication Service Provider (CSP) voice service revenues continue to face pressure due to shifts in communication preferences and competition from non-traditional service providers. Voice communications are now often embedded into applications outside the domain of traditional telephony voice usage. CSPs have been challenged to effectively leverage and monetize new web-oriented communications technologies.