CLIA Waiver applications declined significantly after FDA’s CLIA Waiver guidance was published on January 30, 2008. Between 2008 and 2012, FDA reviewed 34 applications for CLIA Waiver and approved 14, sometimes taking years to issue a denial. The cost of performing CLIA Waiver studies, combined with the lengthy review times and likelihood of failure, discouraged companies from bringing new innovations to this critical public health sector.
As a result of MDUFA III, passed by Congress in 2012, FDA began accepting and reviewing Dual 510(k) and CLIA Waiver by Applications, and more companies are taking advantage of this new Dual Pathway, which promises shorter review time and higher success rates. Additionally, the 21st Century Cures Act Directs FDA to revise the section on Accuracy in the CLIA Waiver Guidance by the end of 2017. How will these changes impact CLIA Waiver Application outcomes?
You will leave this one and one-half day workshop knowing how to submit either a CLIA Waiver Application or a Dual 510(k) Waiver Application that conforms to FDA’s CLIA Waiver guidance. You will learn how to design risk-based “flex” studies, and develop cost-saving product development and clinical study strategies. We will review FDA’s CLIA categorization criteria and examine ways to incorporate “simple” and “negligible chance of erroneous results” into product design. You will understand how CLIA Waiver requirements have evolved, how the FDA determines performance requirements for CLIA Waiver, what to expect during their review and how to maximize your chances for a successful CLIA Waiver application. Finally, you will gain insights on what to expect from the anticipated new, revised CLIA Waiver guidance.
Learning Objectives:
Upon completing this course participants should be confident in their ability to:
- Understand and follow FDA’s 2008 CLIA Waiver Guidance
- Prepare an effective Pre-Submission for a CLIA Waiver of Dual 510(k) Waiver
- Use the CLIA test complexity scoring criteria
- Integrate human factors into device design
- Design and execute “Flex” studies based on risk analysis
- Design and execute CLIA Waiver or Dual Path clinical studies
- Design and execute studies to evaluate performance at clinical decision points
- Perform and present statistical analysis of data, including ATE and LER
- Develop compliant labeling for CLIA Waived products
- Prepare a CLIA Waiver or a Dual 510(k) Waiver Application
- Avoid costly mistakes
- Maximize the chances for a successful CLIA Waiver application
Who will Benefit:
This course is designed for people who are planning to undertake CLIA Waived product development, and people who will be involved in the supporting studies and submission of applications for CLIA Waiver to FDA. The course will address all levels of interest, from executive to technical and clerical. Personnel who will benefit from attending this course include:
- Executives and Senior managers
- R&D
- Design engineers
- Regulatory professionals
- Project managers
- Risk management professionals
- Clinical research professionals
- 08.30 AM - 09.00 AM: Registration
- 09.00 AM: Session Start
- History of CLIA Waiver Regulations
- Using CLIA Complexity Categorization Score Card
- FDA’s 2008 CLIA Waiver Guidance
- 2 Tiers of Insignificant Risk of Erroneous Results
- Integrating human factors into device design
- Designing risk and flex studies
- Fail-safe and error alert
- Designing Accuracy Studies
- Quantitative tests
- Selecting comparator method
- Site and operator selection
- Finding ATE and LER Zones
- Qualitative tests
- Selecting comparator method
- Site and operator selection
- Near Cutoff Studies
- Quantitative tests
- FDA’s Dual 510(k) Waiver by Application
- Importance of the Pre-Submission Program
- Case Studies
- Labeling requirements
- Hands-on: Preparing graphs with ATE and LER in Microsoft® Excel®
- Questions and wrap-up
Glenn Neuman
Director of Scientific Affairs at New World Regulatory Solutions, Inc.
Glenn Neuman is a seasoned Regulatory Affairs professional with an R&D background. Mr. Neuman has over 20 years’ experience with CLIA Waivers, and presented at CLIAC meetings and at FDA’s watershed CLIA Waiver public workshop in August of 2000. He has been intimately involved with the CLIA Waiver process throughout its evolution to the present day. He has served as the Director of Scientific Affairs for New World Regulatory Solutions, Inc. (NWRS) since 2004. NWRS is an independent consulting firm that works with start-up to global 500 companies in the areas of device design and human factors, risk management, clinical studies, regulatory submissions to FDA and quality system regulations.
Prior to joining NWRS in 2004, he was Director of R&D and then Director of Regulatory, Quality and Technical Affairs at Wampole Laboratories during its ownership by Carter Wallace and Inverness Medical Innovations (now Alere), respectively. He holds a Master’s degree in biochemistry from the University of Maine.
Register Now
Online using Credit card
Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at [email protected]
Other Registration Option
- Download the Order Form
- Fill this form with attendee details & payment details
- Fax it to +1-650-362-2367, or
- Email it to [email protected]
Payment Mode
ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA
Register / Pay by Wire Transfer
Please contact us at +1-888-717-2436 to get details of wire transfer option.Terms & Conditions to Register for the Seminar/Conference/Event
Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]
Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).
Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.
Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.
Offers:
- Logo on name cards
- Logo placement on the podium
- Logo on the lanyards for all speakers
- Exclusive stall at the entrance
- A full page brochure advert
- Moving banner ad on the website
- Logo on promotional email campaign
- Logo on name cards
- A half page brochure advert
- Exclusive stall at the entrance
- A quarter page brochure advert
- Moving banner ad on the website
- Logo on name cards
- Logo placement on the podium
- Logo on the lanyards for all speakers
- Exclusive stall at the entrance
- A full page brochure advert
- Moving banner ad on the website
- Logo on promotional email campaign
- Logo on name cards
- A half page brochure advert
- Exclusive stall at the entrance
- A quarter page brochure advert
If you wish to partner with us for this event please contact us: [email protected] or call us: +1-888-717-2436.
- Logo on name cards
- Logo placement on the podium
- Logo on the lanyards for all speakers
- Exclusive stall at the entrance
- A full page brochure advert
- Logo on promotional email campaign
- Logo on name cards
- A half page brochure advert
- Exclusive stall at the entrance
- A quarter page brochure advert
- Moving banner ad on the website
- Logo on name cards
- Logo placement on the podium
- Logo on the lanyards for all speakers
- Exclusive stall at the entrance
- A full page brochure advert
- Moving banner ad on the website
- Logo on promotional email campaign
- Logo on name cards
- A half page brochure advert
- Exclusive stall at the entrance
- A quarter page brochure advert
- Moving banner ad on the website
If you wish to sponsor this event please contact Cruise Webster: [email protected] or call us: (207) 576-4173
Local Attractions of Chicago, IL
Windy
One of the more breathtaking scenes on the lake is this tall ship approaching the docks at Navy Pier. The 148-foot four-masted schooner (and its new sister ship, the Windy II ) sets sail for 90-minute cruises two to five times a day, both day and evening. (Because the boats are sometimes booked by groups, the schedule changes each week; call first to confirm sailing times). The boats are at the whims of the wind, so every cruise charts a different course. Passengers are welcome to help raise and trim the sails and occasionally take turns at the ship's helm (with the captain standing close by). The boats are not accessible for people with disabilities.
Adler Planetarium and Astronomy Museum
The building may be historic (it was the first planetarium in the Western Hemisphere), but some of the attractions here will captivate the most jaded video-game addict.
Your first stop should be the modern Sky Pavilion, where the don't-miss experience is the StarRider Theater. Settle down under the massive dome, and you'll take a half-hour interactive virtual-reality trip through the Milky Way and into deep space, featuring a computer-generated 3-D-graphics projection system and controls in the armrest of each seat. Six high-resolution video projectors form a seamless image above your head -- you'll feel as if you're literally floating in space. If you're looking for more entertainment, the Sky Theater shows movies with an astronomical bent; recent shows have included Secrets of Saturn and Mars Now!
Arlington International Racecourse
With its gleaming-white, palatial, six-story grandstand and lush gardens, this racecourse is one of the most beautiful showcases for thoroughbred horse racing in the world. Its storied history stretches back to 1927, and such equine stars as Citation, Secretariat, and Cigar have graced the track. The annual Arlington Million (the sport's first million-dollar race, held in mid-Aug) attracts top jockeys, trainers, and horses and is part of the World Series Racing Championship, which includes the Breeders Cup races. Arlington's race days are thrilling to behold, with all of racing's time-honored pageantry on display -- from the bugler in traditional dress to the parade of jockeys.
Art Institute of Chicago
You can't -- and shouldn't -- miss the Art Institute. (You really have no excuse, since it's conveniently located right on Michigan Ave. in the heart of downtown.) No matter what medium or century interests you, the Art Institute has something in its collection to fit the bill. Japanese ukiyo-e prints, ancient Egyptian bronzes, Greek vases, 19th-century British photography, masterpieces by most of the greatest names in 20th-century sculpture, and modern American textiles are just some of the works on display, but for a general overview of the museum's collection, take the free "Highlights of the Art Institute" tour Saturday and Sunday.
Auditorium Building and Theatre
A truly grand theater with historic-landmark status, the Auditorium gives visitors a taste of late-19th-century Chicago opulence. Because it's still a working theater -- not a museum -- it's not always open to the public during the day; to make sure you'll get in, schedule a guided tour, which are offered on Mondays at 10am and noon.
Designed and built in 1889 by Louis Sullivan and Dankmar Adler, the 4,000-seat Auditorium was a wonder of the world: the heaviest (110,000 tons) and most massive modern edifice on earth, the most fireproof building ever constructed, and the tallest building in Chicago. It was also the first large-scale building to be lit by electricity, and its theater was the first in the country to install air-conditioning. Originally the home of the Chicago Opera Company, Sullivan and Adler's masterpiece is defined by powerful arches lit by thousands of bulbs and features Sullivan's trademark ornamentation -- in this case, elaborate golden stenciling and gold plaster medallions. It's equally renowned for otherworldly acoustics and unobstructed sightlines.
