ComplianceOnline

FDA's recall authority and program launches you into a project of crisis management. You will learn how to establish a roadmap for conducting recalls. The knowledge you gain will sharpen your recall management decisions and strategy. You will learn how to use the FDA's health risk criteria so you can develop effective recall procedures. One critical aspect of recalls involves the identification of the root cause of the recall and how you could or should prevent that problem from happening again. Your corrective and preventive action program (CAPA) and quality assurance functions require a rigorous approach to prevent a chronic history of recalls. Reiterative recalls lead the FDA to the conclusion that, "You don't get it."

Your compliance competency becomes a regulatory issue for the FDA if your recall is deemed ineffective. The seminar will cover critical performance targets for conducting an effective recall. You will learn how missteps in the recall process become an expensive problem in terms of money and a sloppy corporate image.

You will take away practical knowledge on how to work with FDA staff during a recall, and how you can prepare for inspectional follow up or a regulatory action, and in some cases a legal action. You will learn that your approach to recalls plays a major role in mitigating direct and indirect damage to your firm's business. A firm with a history of chronic recalls needs to learn how to get out of that downward spiral. Likewise, for established and new firms you will learn how you can reduce the negative impact of a recall with the use of proper planning.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

  • Understand FDA's recall authority and policy
  • Learn how to manage recalls under FDA oversight
  • Learn how to interact with FDA
  • See how to develop health risk determinations
  • Learn critical recall strategy components
  • Manage possible FDA enforcement actions

Who will Benefit:

  • Recall managers
  • Quality assurance managers
  • Regulatory affairs directors
  • Risk and product liability managers
  • Manufacturers’ sales and marketing managers
  • Own label distributors

Companies and departments:

  • Manufacturers
  • Own Label Distributors
  • Importers
  • Healthcare institutions
  • Nursing homes
  • Medical practice groups

Topic Background:

The products regulated by the FDA can cause serious adverse health consequences or death. The FDA's recall program is designed to make sure firms' recalls can mitigate such problems, even when the adverse consequence seems remote. The FDA's recall program has remained relatively the same over several years. How the FDA and industry manage recalls and learn from their mistakes continues to evolve. In some ways recalls have become more efficient through the benefit of technology. In other ways the reason for recalls remains substantially the same. The FDA's recall procedures and regulatory management of any risk to health are still sufficient to determine whether a recall is effective and whether manufacturers learn from their mistakes.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Day 1 - Morning
  • FDA’s Regulatory Authority
    • Recall Regulations
      • Voluntary recall: 21 Code of Federal Regulations (C.F.R.) Part 7
      • Mandatory recall actions
        • 21 C.F.R. Part 810
        • 21 C.F.R. Part 806
    • Recall Classification
      • Violation of the law
  • Break (10:30 a.m. – 10:45 a.m.)
      • Risk to Health
      • Precedents
      • Exemptions
        • Stock Recovery
        • Product Withdrawal
        • Product Improvement
  • Lunch (12:00 p.m. to 1:00 p.m.)
  • Day 1 / Afternoon
  • Recalls and risk to health
    • Risk to health categories
      • Death
      • Serious injury / serious illness
      • Non-reversible / reversible
      • May cause, if it were to recur
      • Remote possibility
  • Break (2:30 p.m. – 2:45 p.m.)
    • Health Hazard Evaluation for Recall Classification
      • FDA’s internal evaluation
      • Vulnerable subpopulations
      • Scoring
      • Participants
      • Industry HHE equivalent
      • FDA’s recall database
Day 02(8:30 AM - 4:30 PM)
  • Day 2 - Morning
  • FDA’s Recall Procedures
    • Understanding FDA’s program and implementation
    • FDA’s agency-wide recall procedures
    • The FDA’s investigator’s job
    • Preparing a recall strategy
  • Break (10:30 a.m. – 10:45 a.m.)
    • Preparing for FDA oversight
    • Recall notification to FDA’s District Office
    • Recall notification to the public
  • Lunch (12:00 p.m. to 1:00 p.m.)
  • Day 2 / Afternoon
    • Root cause identification
    • Correction and Prevent Action (CAPA)
  • Break (2:30 p.m. – 2:45 p.m.)
    • FDA inspectional follow up
    • Enforcement: FDA administrative and legal remedies
    • End
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Casper (Cap) Uldriks

Casper (Cap) Uldriks
Former Associate Center Director of FDA's CDRH

Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card

$999.00

Seminar One Registration

August 3-4, 2017, Salt Lake City, UT
(Registrations till June 30, 2017 - $999)
(Registrations till July 25, 2017 - $1299)
(Registrations after July 25, 2017 - $1499)

$1,499.00

Seminar One Registration (With 2 Nights Stay)

August 3-4, 2017, Salt Lake City, UT

$4,599.00
$5,994.00 (23%)*

Save $1,395.00

Special Group Discount Register for Six attendees

August 3-4, 2017, Salt Lake City, UT
*Hurry! This option is limited and based on availability.
Great Savings with Group Ticket!!! Only 3 left




Early bird seats are limited and based on first-come, first-serve.

The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both the days.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 200
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us 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 @ customercare@complianceonline.com

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.

Online using Credit card

$999.00

Seminar One Registration

October 19-20, 2017, Boston, MA
(Registrations till June 30, 2017 - $999)
(Registrations till July 25, 2017 - $1299)
(Registrations after July 25, 2017 - $1499)

$1,499.00

Seminar One Registration (With 2 Nights Stay)

October 19-20, 2017, Boston, MA

$4,599.00
$5,994.00 (23%)*

Save $1,395.00

Special Group Discount Register for Six attendees

October 19-20, 2017, Boston, MA
*Hurry! This option is limited and based on availability.
Great Savings with Group Ticket!!! Only 3 left




Early bird seats are limited and based on first-come, first-serve.

The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both the days.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 200
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us 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 @ customercare@complianceonline.com

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.

Location 1:

Salt Lake City, UT
(Venue to be announced shortly)

August 3-4, 2017

Location 2:

Boston, MA
(Venue to be announced shortly)

October 19-20, 2017

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Media Partners
Platinum Partner
  • 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
Gold Partner
  • 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
Silver Partner
  • 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
Bronze Partner
  • 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: partner@complianceonline.com or call us: +1-888-717-2436.

Sponsors
Platinum Partner
  • 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
Gold Partner
  • 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
Silver Partner
  • 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
Bronze Partner
  • 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: cwebster@complianceonline.com or call us: (207) 576-4173

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Local Attractions of Salt Lake City, UT

Temple Square and Related Sites

Temple Square and Related Sites

Temple Square is Salt Lake City's most popular attraction. With its grand six-spired temple, two visitor's centers, lovely flower gardens and fountains - and nearby sites related to the Church of Jesus Christ of Latter-Day Saints. Area attractions include the Assembly Hall, Tabernacle, Museum of Church History and Art, Family Search Center, Beehive House, Lion House, Brigham Young Historic Park, LDS Conference Center and Joseph Smith Memorial Building. Temple Square offers hundreds of free movies, dramatic programs and music events every year.

The Gateway

The Gateway

The Gateway on the west side of downtown Salt Lake is the city's best outdoor shopping center.

City Creek Center

City Creek Center

It's designed to be a walkable shopper's paradise, with six acres of green space, the namesake creek, two 18-foot waterfalls, and a massive retractable roof.

Capitol Hill

Capitol Hill

The Utah State Capitol, at 300 N. State St., sits atop a hill overlooking the Salt Lake Valley. The building was constructed in 1912-1916 and renovated in 2004-2008.

Hogle Zoo

Hogle Zoo

Utah's Hogle Zoo dates from 1931 and is located at the mouth of Emigration Canyon at 2600 E. Sunnyside Avenue. The Zoo is one of the most visited attractions in Utah and the top paid-for tourist attraction in Salt Lake City. It covers 42 acres and includes more than 800 animals.

This is the Place Heritage Park

This is the Place Heritage Park

This is the Place Heritage Park includes a restored pioneer village with live demonstrations of pioneer life and a restored Brigham Young farmhouse.

Local Attractions of Boston, MA

Boston Public Garden

Boston Public Garden

This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.

Boston Public Library

Boston Public Library

The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessible by taking the Green Line to Copley station (or also near to Orange Line Back Bay stop).

Fenway Park

Fenway Park

Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.

Museum of Fine Arts

Museum of Fine Arts

Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyptian collections and early American art.

Museum of Science

Museum of Science

The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space travel to wildlife to physics to human biology to an in-depth look at Boston's "Big Dig" project.

North End

North End

This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights.

Old North Church

Old North Church

The signal from the steeple of Boston's oldest church triggered the War for Independence that led to the birth of America. On that fateful night in 1775, the two lanterns in the steeple told Paul Revere that the British were approaching by boat, not on foot.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

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