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
  • Recall procedures (What FDA expects from you.)
    • FDA Field Office Management
    • FDA Center(s) Management
    • The firm’s job
  • 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.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
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

March 23-24, 2017, Chicago, IL
(Registrations till January 10, 2017 - $1499)
(Registrations till February 5, 2017 - $1599)
(Registrations till March 5, 2017 - $1699)
(Registrations after March 5, 2017 - $1899)

$2,099.00

Seminar One Registration (With 2 Nights Stay)

March 23-24, 2017, Chicago, IL

$6,799.00
$8,994.00 (24%)*

Save $2,195.00

Special Group Discount Register for Six attendees

March 23-24, 2017, Chicago, IL
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Early bird seats are limited and based on first-come, first-serve.

Your registration fee includes the workshop, all course materials and lunch.


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

Other Registration Option

By order form / PO#

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Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 200
Palo Alto, CA 94303
USA

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Please contact us to get details of wire transfer option.

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.

Online using Credit card

$1,499.00

Seminar One Registration

June 15-16, 2017, San Diego, CA
(Registrations till January 10, 2017 - $1499)
(Registrations till February 5, 2017 - $1599)
(Registrations till March 5, 2017 - $1699)
(Registrations after March 5, 2017 - $1899)




Early bird seats are limited and based on first-come, first-serve.

Your registration fee includes the workshop, all course materials and lunch.


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 East Bayshore Road Suite 200
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us to get details of wire transfer option.

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 1:

Chicago, IL
(Venue to be announced shortly)

March 23-24, 2017

Location 2:

San Diego, CA
(Venue to be announced shortly)

June 15-16, 2017

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Media Partners
Platinum Partner
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  • 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
Gold Partner
  • Logo on promotional email campaign
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Silver Partner
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  • 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

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

Sponsors
Platinum 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
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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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.

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.

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.

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.

Local Attractions of San Diego, CA

San Diego Cabrillo National Monument

San Diego Cabrillo National Monument

Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line.

Sea Creatures at Birch Aquarium

Sea Creatures at Birch Aquarium

Birch Aquarium is north of San Diego in La Jolla. It's not as big as some of the other aquariums in California or as flashy as the big sea-themed park down the road, but instead just right, filled with interesting exhibits and home to leafy sea dragons like the one above, creatures so improbably they look more like something from a children's book than from the ocean.

Legoland

Legoland

Legoland theme park takes its inspiration from Lego toys, those cute little bricks that snap together to build all kinds of fun things. It's one of several Legolands worldwide.

San Diego Zoo Safari Park

San Diego Zoo Safari Park

The San Diego Zoo's sister park offers a different kind of animal experience. Its name (Safari Park) is the clue and it indeed offers a more safari-like experience. Lots of large animals live in the same big, open areas here - predators kept away from prey, but otherwise much as they would in their natural habitat.

Coronado Island

Coronado Island

Coronado isn't really an island but a peninsula - a fact that doesn't get in the way of the name most people use for it. Whatever you call it, it's on a slender strip of land between the San Diego Bay and the Pacific Ocean, barely a few blocks wide. What it lacks in size it makes up for in fun, with a beach that's been named among the best in the country, a classic hotel and a compact, lively little downtown. Coronado's laid-back temperament makes a nice break from the busier parts of San Diego across the water.

Balboa Park

Balboa Park

Originally built for temporary use during the 1915-16 Panama-California Exposition in San Diego, Balboa Park boasts buildings beautiful enough to be considered attractions in themselves, especially if you're a photographer. They're surrounded by trees, lawns and fountains, but that's only the beginning.

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