ComplianceOnline

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 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.

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

FDA conducts inspections based on well established procedures. You can lower your anxiety level when you can predict what they will do during an inspection, what products they cover and how they will document your problems. Any type of regulated firm should the ground rules of an inspection to keep it under control. You should be able to see the hand writing on the wall if it looks bad and prepare accordingly. You should understand what is at stake based on the progress of an inspection. How you respond to an investigator, to the inspection in general and to the FDA can seal your fate to an unhappy ending if you don’t know what to do, how to do it and how fast you need to do it. Questions are encouraged. What did you want to know about FDA, but were always afraid to ask? What are the big mistakes firms make? Here the firsthand accounts of an ex-FDA investigator.

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

Topic Background:

FDA inspections can have a big impact on a firm’s budget, public image, customers, employees and stockholders. No one wants the bad news that the FDA investigator puts on a written list of observations, aka the “483.” Your 483 is like a report card that your teacher shows to everyone else in the class. What an investigator finds pulls together many different legal, administrative and technical factors that end up showing you and the public where you stand with the FDA. Inspections cover a wide range of products and an equally broad range of establishments, so preparing for and understanding an inspection takes work that is specific to your firm.

FDA inspections are assigned for many different reasons. Safety (risk to health) plays a major role in how FDA selects firms for inspections. Firms can estimate their likely risk status in terms of FDA’s regulatory interest. Once a firm is selected for inspection, how the inspection is conducted becomes a make-or-break situation. Inspections are designed to find problems. They are inherently uncomfortable for the people who host the investigator during the inspection. Predicting what an investigator will do during an inspection becomes helpful in how you manage a difficult situation to avoid a potentially disastrous and costly result.

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Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • 9:00 – 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
  • Lunch 12:00 – 1:00 p.m.
  • 1:00 – 2:30 p.m.
    • Inspection strategy and technique (cont.)
  • Break 2:30 p.m. – 2:45
  • 2:45 – 4:30p.m.
    • Inspection strategy and technique
    • War rooms
Day 02(8:30 AM - 4:30 PM)
  • 9:00 – 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
  • Lunch 12:00 – 1:00 p.m.
  • 1:00 – 2:30 p.m.
    • Recall actions and procedures
    • The field District Office
    • The Center(s)
    • The recalling firm
    • Notifying the public
  • Break 2:30 – 2:45 p.m.
  • 2:45 – 3:00 p.m.
    • Follow up inspections
    • Corrective and Preventive Actions
  • 3:00 – 4:30 p.m.
    • Foreign inspections
    • Import Alert
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.

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$1,499.00

Seminar One Registration

April 2-3, 2020, Chicago, IL
(Registrations till November 20, 2019 - $1499)
(Registrations after November 20, 2019 - $1699)




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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.

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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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Offers:

  • Early bird seats are limited and based on first-come, first-serve.
  • Multiple offers cannot be combined.
  • Location:

    Chicago, IL
    (Venue to be announced shortly)

    April 2-3, 2020

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    Local Attractions of Chicago, IL

    Windy

    Windy

    One of the more breathtaking scenes on the lake is this tall ship approaching the docks at Navy Pier. The 148-foot four-masted schooner (and its new sister ship, the Windy II ) sets sail for 90-minute cruises two to five times a day, both day and evening. (Because the boats are sometimes booked by groups, the schedule changes each week; call first to confirm sailing times). The boats are at the whims of the wind, so every cruise charts a different course. Passengers are welcome to help raise and trim the sails and occasionally take turns at the ship's helm (with the captain standing close by). The boats are not accessible for people with disabilities.

    Adler Planetarium and Astronomy Museum

    Adler Planetarium and Astronomy Museum

    The building may be historic (it was the first planetarium in the Western Hemisphere), but some of the attractions here will captivate the most jaded video-game addict.
    Your first stop should be the modern Sky Pavilion, where the don't-miss experience is the StarRider Theater. Settle down under the massive dome, and you'll take a half-hour interactive virtual-reality trip through the Milky Way and into deep space, featuring a computer-generated 3-D-graphics projection system and controls in the armrest of each seat. Six high-resolution video projectors form a seamless image above your head -- you'll feel as if you're literally floating in space. If you're looking for more entertainment, the Sky Theater shows movies with an astronomical bent; recent shows have included Secrets of Saturn and Mars Now!

    Arlington International Racecourse

    Arlington International Racecourse

    With its gleaming-white, palatial, six-story grandstand and lush gardens, this racecourse is one of the most beautiful showcases for thoroughbred horse racing in the world. Its storied history stretches back to 1927, and such equine stars as Citation, Secretariat, and Cigar have graced the track. The annual Arlington Million (the sport's first million-dollar race, held in mid-Aug) attracts top jockeys, trainers, and horses and is part of the World Series Racing Championship, which includes the Breeders Cup races. Arlington's race days are thrilling to behold, with all of racing's time-honored pageantry on display -- from the bugler in traditional dress to the parade of jockeys.

    Art Institute of Chicago

    Art Institute of Chicago

    You can't -- and shouldn't -- miss the Art Institute. (You really have no excuse, since it's conveniently located right on Michigan Ave. in the heart of downtown.) No matter what medium or century interests you, the Art Institute has something in its collection to fit the bill. Japanese ukiyo-e prints, ancient Egyptian bronzes, Greek vases, 19th-century British photography, masterpieces by most of the greatest names in 20th-century sculpture, and modern American textiles are just some of the works on display, but for a general overview of the museum's collection, take the free "Highlights of the Art Institute" tour Saturday and Sunday.

    Auditorium Building and Theatre

    Auditorium Building and Theatre

    A truly grand theater with historic-landmark status, the Auditorium gives visitors a taste of late-19th-century Chicago opulence. Because it's still a working theater -- not a museum -- it's not always open to the public during the day; to make sure you'll get in, schedule a guided tour, which are offered on Mondays at 10am and noon.
    Designed and built in 1889 by Louis Sullivan and Dankmar Adler, the 4,000-seat Auditorium was a wonder of the world: the heaviest (110,000 tons) and most massive modern edifice on earth, the most fireproof building ever constructed, and the tallest building in Chicago. It was also the first large-scale building to be lit by electricity, and its theater was the first in the country to install air-conditioning. Originally the home of the Chicago Opera Company, Sullivan and Adler's masterpiece is defined by powerful arches lit by thousands of bulbs and features Sullivan's trademark ornamentation -- in this case, elaborate golden stenciling and gold plaster medallions. It's equally renowned for otherworldly acoustics and unobstructed sightlines.

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