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.

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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
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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.

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Online using Credit card

$1,599.00

Seminar One Registration

February 9-10, 2017, San Jose, CA
(Registrations till December 20, 2016 - $1599)
(Registrations till January 20, 2017 - $1699)
(Registrations after January 20, 2017 - $1899)

$2,199.00

Seminar One Registration (With 2 Nights Stay)

February 9-10, 2017, San Jose, CA

$7,299.00
$9,594.00 (23%)*

Save $2,295.00

Special Group Discount Register for Six attendees

February 9-10, 2017, San Jose, CA
*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 days.


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

Other Registration Option

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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:

San Jose, CA
(Venue to be announced shortly)

February 9-10, 2017

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If you wish to partner with us for this event please contact us: partner@complianceonline.com or call us: +1-888-717-2436.

Sponsors
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  • 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

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Campbell Historical Museum

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The Campbell Historical Museum and Ainsley House may have been procured from the city of San Jose by Campbell, but this adorable English Tudor is still the perfect visiting stop for anyone in the county looking for a plush little getaway from modern times. The iconic English Tudor is elegantly restored and filled with many of the Ainsley's original furnishings (the couple built the house in 1925 to resemble the cottages of their native Britain). Bring a folding chair and a picnic basket for a series of free outdoor concerts every Thursday evening. Just because the setting is classic doesn't mean you can't engage in some modern fun.

Campo di Bocce

Campo di Bocce

Just outside of the San Jose city limits, Campo di Bocce is a unique venue that remains a favorite San Jose attraction. With a full restaurant offering delicious Italian cuisine, a bar doling out everything from sodas to cocktails, and several bocce courts where everyone from family to friends to co-workers can try their hand at bocce ball and engage in light competition or just a fun and casual game.

Children's Discovery Museum

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Imagine driving a luxury or exotic car without the pressures and expenses of ownership and maintenance. Club Sportiva is the most established luxury car time-share in the nation, with memberships that put drivers behind the wheel of the world's finest cars a few days each month. Members also enjoy benefits like social events, dinners, road rallies and other exclusive VIP services. Limited-production Ferraris and Lamborghinis and electric Tesla Roadsters are available now.

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Electric Indoor Kart Racing

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