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Medical Device Recall - FDA Authority, Policy and Best Practices to Avoid / Manage: 2-day In-person Seminar

By:
Casper E. Uldriks, Ex- FDA Expert & Former Associate Center Director of CDRH
Coming soon.. Please contact customer care for new schedule

Course Description:

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 recall management knowledge you gain will sharpen how you determine the health and legal risks associated with your recall and what you can do to avoid future recalls. You will understand the critical performance targets to accomplish an effective recall and learn how missteps in the recall process become counterproductive and expensive. 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 an enforcement action. You will learn that your approach to an enforcement action plays a major role in mitigating the firm’s business consequences due to a recall. 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 likelihood or significance of a recall with proper planning.

Learn practical tips from your course instructor Mr. Casper (Cap) Uldriks who brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, senior manager in the Office of Compliance and as an Associate Center Director in the Center for Devices and Radiological Health. Many of his engagements focus on advertising and promotion, recalls, corrections and removals and enforcement. His comments are candid and of practical value. He understands how the FDA thinks, operates and where it is headed. He developed enforcement actions, participated in the implementation of new statutory requirements, managed device regulatory programs and was recognized as the agency’s expert in a number of statutory provisions and regulations.


Learning Objectives:

  • Understand FDA’s recall authority and policy
  • Learn the mandatory requirements for device recalls
  • Learn how to interact with FDA
  • See how to develop health risk determinations
  • Learn critical recall strategy components
  • Identify options for FDA enforcement action


Who will Benefit:

Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling.

  • Quality & Regulatory Professionals
  • Manufacturing & Design Engineers
  • Marketing Product Managers
  • Documentation
  • Complaint handling personnel
  • Clinical affairs
  • Product and development
  • Site managers, and consultants
  • Contract manufacturing organization
  • Contract research organization
  • Senior and executive management
  • Contractors and subcontractors



Course Outline:

Day One: 8:00 AM - 4:30 PM     Day Two: 8:30 AM - 4:30 PM

Day 1 / Morning

FDA’s Regulatory Authority

  • “Correction and Removal”
  • Regulations
  • Voluntary
    • Part 7
  • Mandatory
    • Part 806
    • 21 U.S.C. 360 h (e)
    • Part 810
  • Criteria
    • Violation of the law
    • Risk to Health
    • Exemptions

Day 1 / afternoon

Recalls and risk to health

  • Health Hazard Evaluation
    • FDA’s internal evaluation
    • Vulnerable subpopulations
    • Scoring
    • Participants
    • Industry HHE equivalent
  • Recall risk based classification
    • Class I
    • Class II
    • Class III
  • Device classification (class)
    • Confusion with a recall “class”
    • Statutory basis
    • Differences in purpose
  • Device mandatory reporting regulations
    • Medical Device Reports – Part 803
    • Corrections and Removals – Part 806
    • Medical Device Tracking – Part 821

   

Day 2 / Morning

Understanding FDA’s approach to recalls

  • Recall programs
    • Understanding FDA’s program and implementation
    • FDA’s Regulatory Procedures Manual – Chapter 7
    • FDA’s Investigations Operation Manual – Chapter 7
    • Preparation for FDA oversight
    • Recall notification to FDA’s District Office
    • Recall notification to the public
  • Root cause identification
  • Correction and Prevent Action (CAPA)
  • FDA inspectional follow up
  • Recall Exemptions
    • Withdrawal
    • Product Recovery
    • Improvement

Day 2 / afternoon

  • Recall expansion or termination
  • Total product life cycle
  • FDA premarket guidance
  • Enforcement
  • FDA administrative and legal remedies




Meet Your Instructor

Casper (Cap) Uldriks
An ex- FDA expert and former Associate Center Director of CDRH

Casper (Cap) Uldriks brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, senior manager in the Office of Compliance and as an Associate Center Director in the Center for Devices and Radiological Health. He developed enforcement actions, participated in the implementation of new statutory requirements, managed device regulatory programs and was recognized as the agency’s expert in a number of statutory provisions and regulations. Starting in 1995, he trained the FDA’s investigators on the FDA’s legal authority and CDRH’s regulatory requirements and procedures. He continues to teach the FDA’s employees to this day. He is recognized and sought out as an exceptional and energetic speaker. Many of his engagements focus on advertising and promotion, recalls, corrections and removals and enforcement. His comments are candid and of practical value. He understands how the FDA thinks, operates and where it is headed.

Cap also served in the FDA’s Office of Legislative Affairs for 5 years as the FDA’s congressional liaison for its medical device program. As a federal “Legislative Fellow” he worked for one year in a congressional subcommittee for the Energy and Commerce Committee where he drafted proposed FDA legislation for the regulation of human tissue. He managed and wrote testimony for the Commissioner for several congressional oversight hearings concerning FDA’s device program.

Cap now works almost exclusively on medical device issues at Olsson, Frank, and Weeda (OFW Law) in Washington, D.C. He counsels clients on wide range of topics, including: FDA inspections; import operations; advertising and promotion; corrective and preventive actions; medical device reporting and corporate reorganization to improve conformance to the FDA’s requirements.




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Venue

Location 1:

Special Offer for the attendees of this seminar:

Rooms available at only $119 per night.

Call at 1-952-835-7800 and give the reference "ComplianceOnline Group" to book your rooms at discounted rates at DoubleTree Bloomington - Minneapolis South Hotel.

Hotel rooms are limited and based on availability.




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How to Reach

Highlights

  • Just ten minutes from Minneapolis/St. Paul International Airport (MSP) and the Mall of America
  • Ideal destination for vacationing visitors and corporate travelers

General Directions

From North

  • Take interstate 35W south to highway 62 west
  • Take highway 100 south to Industrial Boulevard and the hotel is located on the right.

From South

  • Take 35W north to interstate 494 west
  • Then to highway 100 north
  • Exit at Industrial Boulevard
  • Take west to Normandale Boulevard
  • Turn south and the hotel will be located to your right.

From East

  • From the airport, take I-494 west
  • Exit at highway 100 north
  • Exit at Industrial Boulevard
  • Take west to Normandale Boulevard
  • Turn south and the hotel will be located to your right.

From West

  • Take I-494 south to Highway 100 North
  • Exit at Industrial Boulevard
  • Take west to Normandale Boulevard
  • Turn south and the hotel will be located to your right.

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




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