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  • Managing Domestic and Foreign FDA Inspections and the COVID-19 Impact
2-Day Virtual Seminar by Ex-FDA Official

Managing Domestic and Foreign FDA Inspections and the COVID-19 Impact

BY: Casper E. Uldriks, Former Associate Center Director of FDA's CDRH

Virtual Training Through WebEx
Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.

Simu Live
(On-demand Streaming - Virtual Training Through WebEx)
  • Course Description
  • Agenda
  • Speaker
  • Price/Register

FDA inspects many different kinds of firms. If the FDA regulates your product, they can show up at your lobby and say, “I am here to conduct an inspection.” What do you do? What have you done to prepare for an inspection? How do you deal with the investigator, including their personality? The scary part is having to explain the error of your ways to the FDA and above all, managing an administrative action, e.g., Warning Letter or Import Alert, or a legal action, e.g., civil money penalties, seizure, injunction or prosecution. This course will help you with what you need to know and what you should do to survive an FDA inspection with the least possible pain.

Seminar Instructor Casper Uldriks is an "Ex-FDA Official" who has spent 32 years in FDA. He currently trains FDA personnel and 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.

He understands how FDA thinks, operates and where it is headed.

The course will cover the factors used by the FDA to schedule inspections. You will learn how to predict what an FDA investigator will do and what they will cover in the inspection. There should be no surprises if you have prepared properly. Firms need to understand the details about inspectional techniques to avoid making new problems for yourself during the inspection. You can save yourself a lot of corporate misery if you know what to do before, during and after an inspection.

Learning Objectives:
  • FDA legal authority to inspect
    • Over products
    • Over firm’s
      • Scientific/clinical studies
      • Premarket requirements
      • Postmarket requirements
  • FDA’s annual inspection work plan
  • Inspection Procedures
    • FDA inspection Manuals
    • FDA Training
    • Documenting violations
    • Refusals
    • Human factors
  • Recall procedures (What FDA expects from you.)
    • FDA Field Office Management
    • FDA Center(s) Management
    • The firm’s job
  • Inspectional observations (Form FDA-483)
  • Responding to a 483
  • Responding to a Warning Letter
  • FDA enforcement actions
  • Follow up inspections
  • Foreign Inspections
Who will Benefit:

When you interact with the FDA, you need to look at yourself through FDA’s eyes. You can understand the purpose of an inspection, what the investigator will do and what it means for you. Once you learn how to read the signals you are better equipped to mitigate regulatory damage and, best of all, take the drama and mystique out of an inspection. The information in the course gives you rational and comprehensive approach so you do not feel like a deer staring at the headlights. If you know what the investigator is doing and you understand your job, your receptionist will not need a panic button.

  • Regulatory Affairs Directors
  • Quality Assurance Managers
  • Quality Control Managers
  • Manufacturing Directors and Managers
  • Product Risk Managers
  • Venture Capitalists
Day 01(8:30 AM - 2:30 PM PDT)
  • 8:30 – 10:30 a.m.
    • FDA Legal Authority
    • FDA inspection plans and risk
    • Preparing for an inspection
  • Break 10:30 – 10:45 a.m.
  • 10:45 – 12:00 p.m.
    • FDA Inspection Procedures
    • FDA staff guidance
    • FDA staff training
  • Break 12:00 – 12:15 p.m.
  • 12:15 – 1:30 p.m.
    • Inspection strategy and technique (cont.)
  • 1:30 – 2:30p.m.
    • Inspection strategy and technique
    • War rooms
Day 02(8:30 AM - 2:30 PM PDT)
  • 8:30 – 10:30 a.m.
    • Documenting violations
    • Collecting “samples”
    • Responding to inspectional observation (The “483”)
  • Break 10:30 – 10:45 a.m.
  • 10:45 – 12:00 p.m.
    • Responding to a Warning Letter
    • Legal enforcement actions
  • Break 12:00 – 12:15 p.m.
  • 12:15 – 1:30 p.m.
    • Recall actions and procedures
    • The field District Office
    • The Center(s)
    • The recalling firm
    • Notifying the public
  • 1:30 – 2:30 p.m.
    • Follow up inspections
    • Corrective and Preventive Actions
    • Foreign inspections
    • Import Alert
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 Now

Location
Simu Live
(On-demand Streaming)

Online using Credit card

$1,299.00

(One Dial-in One Attendee)

(After registration, we will video stream the training
on your convenient dates)

$6,999.00

Group-Max. 10 Attendees

(After registration, we will video stream the training
on your convenient dates)


For discounts on multiple registrations, contact customer care at +1-888-771-6965.

Other Registration Options

By order form / PO#

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To pay by check please contact customercare@fdatrainingalert.com

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Register / Pay by Wire TransferPlease contact us at +1-888-771-6965 to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event »

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 @ +1-888-771-6965 or email us @ customercare@fdatrainingalert.com

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Payment is required before 2 days of 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 from 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 FDATrainingAlert event and a credit note will be issued.

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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.

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