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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Register Now

Online using Credit card

$1,299.00

Seminar One Registration

October 10-11, 2019, Washington, DC
(Registrations till September 11, 2019 - $1299)
(Registrations after September 11, 2019 - $1499)




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

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 E. Bayshore Road Suite 260
Palo Alto, CA 94303
USA

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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

Courtyard Washington, DC/U.S. Capitol
1325 2nd Street NE,
Washington, DC 20002-3582, USA
Tel: +1-202-898-4000

October 10-11, 2019

How to Reach

General Driving Directions:

Driving Directions from Reagan National Airport – DCA: Hotel direction: 6.6 mile(s) SW
  • Take US-1 ramp right (north) toward I-395 N/Washington/I-66 West
  • Turn right onto US-1 North
  • Merge onto I-395 N toward Washington
  • Turn right onto New York Ave NW/US-50
  • Turn right onto Florida Ave NE
  • Turn right on 2nd Street NE.
Driving Directions from Washington Dulles International Airport – IAD: Hotel direction: 29 mile(s) W
  • Take Dulles Airport access road East toward Washington
  • Take exit VA 267 East
  • Exit onto I-495 toward Baltimore/Bethesda MD
  • Take exit #43 onto George Washington Memorial Parkway /Washington
  • Take ramp onto I-395 N toward Washington
  • Turn right on New York Ave NW
  • Turn right on Florida Ave
  • Turn right on 2nd street NE.
Driving Directions from Baltimore/Washington International Thurgood Marshall Airport – BWI: Hotel direction: 30 mile(s) N
  • Exit I-195 West
  • Exit #2B onto MD-295 South
  • Exit US - 50 West
  • Take a left on 1st Street NE
  • Take a left on N street NE
  • Drive around the bend.

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.

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We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.

Benefits of becoming a Sponsor/Exhibitor/Media Partner:

  • Logo on website, marketing email, branding materials & the registration booth
  • Exhibit Space
  • Free event pass
  • Speaking opportunity
  • Social media campaign

For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

Media Partner:

Media Partner


Pharmaceutical-Tech is essentially a B2B online business, technology media platform and global magazine that have under its wraps the largest global database of Pharmacy buyers and suppliers. We cover in-depth trends that shape industry dynamics and metamorphose global economics. Pharmaceutical tech has created a recognition that spans over a global audience, thereby revolutionizing how businesses transact.

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Local Attractions of Washington, DC

Take a Walking Tour

Take a Walking Tour of Old Town, Alexandria

Explore a quaint historic town just over the Potomac River from Washington, DC. The lively waterfront area has plenty of things to do. Visit colonial houses, public parks, churches, museums, a marina, unique shops, and restaurants.

Prudential Center

Walk, Bike, or Kayak Along the C & O Canal

The Washington DC region is lucky to have this wonderful historic park that offers a quick relief from hectic city life. Take the whole family for a walk and learn about the historic C & O Canal, explore the region's bike trails or spend a few hours kayaking and enjoying the breathtaking scenery.

Branch Brook Park

Take a Hike at Great Falls Park

Take a picnic and enjoy spectacular views of the Potomac River at this 800 acre park, located just 14 miles from Washington DC. Great Falls offers a variety of activities including hiking, kayaking, rock climbing, bicycling, and horseback riding.

Cathedral Basilica of the Sacred Heart

Take a Walk Through Georgetown

Georgetown is the capital’s historic waterfront that today is bustling with activity. The area is a shopper’s paradise and the streets are lined with restaurants of every nationality. Take a tour of historic sites, do some shopping and enjoy a meal at a local restaurant.

Newark Symphony Hall

Tour the Three Houses of Government

Explore the U.S. Capitol Building, the White House and the U.S. Supreme Court and you will gain a fuller understanding of the division of power within our democratic government. Plan ahead and note that some tours must be scheduled in advance through your Congressional Representative.

Military Park

See a Show or Concert at the Kennedy Center

Live theatrical productions at the John F. Kennedy Center for Performing Arts are entertainment at its finest. Purchase tickets in advance for performances ranging from musicals to concerts by the National Symphony or see a free show at the Millennium Stage.

Military Park

Explore Mount Vernon

With the recent addition of the new museum and education center, Mount Vernon is now a full day excursion. Explore the state of the art galleries and theaters, visit the 500-acre estate of George Washington and his family, tour the 14-room mansion that is beautifully restored and furnished with original objects dating back to the 1740's. Be sure to plan enough time to tour the outbuildings, including the kitchen, slave quarters, smokehouse, coach house and stables. The estate is located in Northern Virginia, just minutes from Washington, DC.

Military Park

Tour the National Monuments and Memorials

Our national monuments are truly spectacular. The best time to see them is at night when they are illuminated, less crowded and parking is easier. During daytime visits, take a tour bus. Listen to informative park ranger talks and you won’t have to negotiate congested city traffic.

Military Park

Visit the Smithsonian

Start at the Smithsonian Institution Building where you can pick up a map and information on all of the museums. These national treasures cover a wide range of subjects from art to space exploration. Plan to explore those you are most interested in, but don’t try to see everything at once. Be sure to save time to see an IMAX movie at the Natural History Museum or the National Air and Space Museum.

Military Park

Wolftrap Farm Park

Listen to all types of music at this national park dedicated to the performing arts. Outdoor concerts are featured in the summer and indoor performances are held the rest of the year. The park is located in Vienna, Virginia, just 20 minutes from Washington, DC.

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