ComplianceOnline

This interactive one and a half day course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief, who has more than 36 years’ experience with the FDA will provide the participants tools to minimize risk of regulatory enforcement actions.

During the seminar, Ms. Hoffman will explain proper handling of complaints reportable or non-reportable, product complaint handling and documentation, how and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall. She will also discuss how to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real life experiences of FDA.

New to Course will be creating Standard Operating Systems for Post-Market Quality Systems.

Medical Device Reporting (MDR) and recall compliance are critical to the continue survival of all device manufacturers. The FDA is continuing their efforts to issue numerous FDA Warning Letters and serious enforcement actions, including criminal & civil penalties levied on companies that failed to properly report events and take proper corrective and removal actions. The number of device companies having their recall classified as a Class 1 (most severe) recall has surged in the past three years. Additionally, product liability and financial risks are staggering when companies fail to properly report and take action when required. This course will provide an understanding of MDR & recall compliance and the interrelationship of Complaint Handling, CAPA, and Risk Management processes. It will be beneficial to all device manufacturers and is recommended for any individuals or teams that are involved in medical device reporting (MDR) and correction & removal processes, including recalls.

Learning Objectives:

  • Understand how to comply with complicated Compliant Handling, MDR and Recall requirements.
  • Firms MDR reporting and FDA's handling of reports.
  • Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA.
  • Minimize your risk of regulatory enforcement actions.
  • Assist with the creation and maintenance of effective procedures for handling complaints, reportable events and recalls.
  • Understand the relationship and interaction with other quality system elements as they relate to complaints and reportable events.
  • Walk-through of case examples.
  • Step-By-Step guide to designing Standard Operating Systems for communicating process for firm’s success.
  • Discussion of FDA’s New Guidance’s on Risk and how it interacts with Recalls
Seminar instructor Ms. Rita Hoffman is the former FDA CDRH Recall Branch Chief and has more than 36 years of FDA experience across the device, drug and veterinary industries.

Who Will Benefit:

This course will benefit anyone in the medical device industry that handles functions involving product complaints, recalls, medical device reporting.

  • Regulatory Affairs
  • QA/QC
  • Project Managers
  • Regulatory Professional
  • Risk Managers
  • Complaint Handling Teams
  • CAPA Teams
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
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 5:00 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Introduction to class (20 min)
  • Complaint Handling and FDA Expectations (70 min)
    • What is a complaint?
    • Firms Responsibilities and Definitions
    • Complaint Forms
    • FDA Expectations for written procedures on complaint files
  • Medical Device Reporting Procedures (MDR) (60 min)
    • Understand the MDR regulation 21CFR 803
    • Definitions 21 CFR 803.3
    • MDR Procedures 21 CFR 803.17
    • Types of MDR reports
    • MDR reporting by firm, agents and exemptions
  • MDR FDA Perspective (30 min)
    • CDRH Mandatory vs. Voluntary Reporting
    • What happens to an MDR report submitted to FDA
    • Manufacturer and User Facility Device Experience (MAUDE)
    • Medical Products Safety Network (MedSun)
  • User Error Malfunction
    • Identifying a Malfunction
    • Malfunction --To report or not to report
    • Serious injury triggers
    • Person Qualified Makes Medical Judgment
  • Recalls: Definitions and Legal Authority (45 min)
    • What is a recall?
    • Legal Authority (Chapter 7, 21CFR 806)
    • Voluntary vs. Mandatory recalls
    • Definitions – Corrections, Removals
    • Reporting requirements for non-recall field actions
    • Classification system – Classifying a Recall?
      • What is different about Class 1 recall
  • Being Recall Ready –Proactive Steps to Avoid Crisis (45 min)
    • Internal Decision Making
    • Early warning signs
    • Assembling “The Team” – Assigning decision making authority
    • Examples of Close-calls
    • Guidelines and best practices for having contingency plan in place
  • Evaluating Risk and Health Hazard Evaluation (HHE) (60 min)
    • Analyzing adverse event and product quality reports
    • Identifying trends, Data and factors to consider
    • Assessing need to conduct HHE
    • HHE Procedures
    • Human Factors Issues
    • Opening a CAPA to Determine Root Cause
Day 02(8:30 AM - 12:00 PM)
  • Developing effective Strategies and Communicating with FDA (80 min)
    • Elements of a good Recall Strategy
    • What does the FDA expect strategy to contain?
    • Effective Notification Letter to minimize consequences
    • Knowing when to contact FDA District
    • Discussing Recall Strategy with FDA – Seeking input and support of your strategy to avoid common pitfalls
    • Issuance of Press Release and communication with customers
  • Silent Recalls vs. Product Enhancements (20 min)
    • Device changing environment
    • Product improvement (Repair or Modification)
    • Decision 803 or 806
  • Product Retrieval Issues, Effectiveness Checks and Status Reports (50 min)
    • Receiving and accounting for returned products
    • Supply chain challenges – distribution, wholesale, repackaging
    • Global recall market
    • Designing an efficient Effectiveness Checks
    • Coordination and Discussion with FDA
    • Evaluating recall effectiveness Data
    • Developing and formatting status reports
  • Termination of a Recall (15 min)
    • Who, how and when does termination happen
    • Exporting a Recalled Product
    • Communication between firm and District Office
    • Requesting formal closeout by FDA
  • Mock Recall and Wrap-up (35 min)
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Rita Hoffman

Rita Hoffman, RAC,
Managing Partner Regs & Recall Strategies, LLC and Former FDA CDRH Recall Branch Chief

Rita Hoffman, RAC. Managing Partner Regs & Recall Strategies, LLC .Ms. Hoffman has more than 36 years of FDA experience across the device, drug and veterinary industries. She has an intimate understanding of FDA regulatory and compliance issues from the perspective of both FDA and regulated industry. As an FDA compliance consultant, she provides clients with regulatory insight, advises on critical compliance deficiencies, performs compliance and new product audits, provides insight and guidance on recall strategies to the medical device industry, and advises on jurisdiction determinations for combination products.

Ms. Hoffman retired from the FDA in January 2011 as the Recall Branch Chief for the Center for Devices and Radiological Health (CDRH), where she was responsible for oversight and review for all medical device recalls. Ms. Hoffman held several positions including the Center for Drug Evaluation and Research (CDER) Jurisdiction Review Officer (providing guidance on drug/device product designation, combination products and co-packaging), Acting Associate Ombudsman, Small Business Liaison, and was a Policy Analyst for eight years in the Office of the Commissioner. She served as co-chair of RAPS’ Baltimore/Washington Metropolitan Area Chapter for 2-terms, and in 2008 was presented with the Special Recognition Award by RAPS.

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

Register Now

Online using Credit card

$1,599.00

Seminar One Registration

February 2-3, 2017, Tampa, FL
(Registrations till December 20, 2016 - $1599)
(Registrations till January 20, 2017 - $1699)
(Registrations after January 20, 2017 - $1899)

$2,199.00

Seminar One Registration (With 2 Nights Stay)

February 2-3, 2017, Tampa, FL

$7,299.00
$9,594.00 (23%)*

Save $2,295.00

Special Group Discount Register for Six attendees

February 2-3, 2017, Tampa, FL
*Hurry! This option is limited and based on availability.
Great Saving with Group Ticket!!! Only 3 left




The registration fee includes: the workshop; all related course materials; morning tea/coffee on both the days, lunch and afternoon tea/coffee on day one.


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 $150 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 ($150) 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

$1,599.00

Seminar One Registration

May 4-5, 2017, Pittsburgh, PA
(Registrations till December 20, 2016 - $1599)
(Registrations till January 20, 2017 - $1699)
(Registrations after January 20, 2017 - $1899)




The registration fee includes: the workshop; all related course materials; morning tea/coffee on both the days, lunch and afternoon tea/coffee on day one.


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 $150 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 ($150) 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:

Tampa, FL
(Venue to be announced shortly)

February 2-3, 2017

Location 2:

Pittsburgh, PA
(Venue to be announced shortly)

May 4-5, 2017

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Media Partners
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
  • Moving banner ad on the website
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

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

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

Local Attractions of Tampa, FL

Museum of Science

Museum of Science & Industry (MOSI)

More than 450 activities await you at this non-profit facility dedicated to promoting a better understanding of science and technology. The Saunders Planetarium shows you the stars. Step inside the Gulf Coast Hurricane exhibit for a blast of tropical nightmare. At the IMAX Dome Theatre, the world is bigger than life, filled with odd sights and sounds on a huge screen. Souvenirs ranging from totes and T-shirts to puzzles and posters are available at the Science Store. For refreshment, the MOSI Café offers pizzas, salads and sandwiches. In late February, the BARF (Bay Area Renaissance Festival) takes place here.

Salvador Dali Museum

Salvador Dali Museum

Housing the largest collection of Salvador Dali works in the world, the museum offers a regularly changing exhibit of the legendary surrealist artist's melting-watch canvases and a wide variety of his sculpture and fiber objects that are, at the very least, intriguing. One memorable creation toasts the cocktail party; it is a vest covered with full glasses of creme de menthe. Daily tours seek to explain this complex man and his equally complex art. In the museum store you can select a memento of your surreal experience. Do check the website or call for timings.

Tampa Museum of Art

Tampa Museum of Art

Established in 1979, this museum houses more than 4,500 objects in its permanent collection and exhibits the largest collection of Greek and Roman antiquities in the Southeast. The Center Gallery displays themed exhibitions from the permanent collection. For a look at 19th and 20th century sculpture set against the backdrop of the Hillsborough River, visit the Terrace Gallery. Stroll through the Outdoor Courtyard featuring contemporary sculptures, fountains and bronze work. For gifts, books, children's items or home accessories, stop by the museum store.

Craftsman House

Craftsman House

Craftsman House is a gallery that showcases contemporary art works. The lush green lawns and beautiful garden welcome visitors in to this creative space. Owned and managed by Stephanie Schorr, it is a gallery-cum-working studio. Here, you will see umpteen art works displayed; jewelry, glass designs and much more work of local and national artists make for its splendid collection. It also has an on-site café serving delicious short eats and variety of beverages including beer and wines. Apart from the art works, Craftsman House also has a pottery studio that features colorful mugs, pots, vases and other wares that will adorn your living room. The innovative designs and art pieces are truly worth a look; so go ahead and visit the Craftsman House soon.

Adventure Island

Adventure Island

Located right across the street from Busch Gardens Tampa Bay, Adventure Island’s 30 acres of water-drenched fun in the sun features the ultimate combination of high-speed thrills and tropical, tranquil surroundings for guests of all ages. Within a soothing Key West atmosphere await slides, corkscrews, water falls, a wave pool, children’s water playground and other family attractions.

Local Attractions of Pittsburgh, PA

The Andy Warhol Museum

The Andy Warhol Museum

The Andy Warhol Museum is located on the North Shore of Pittsburgh, Pennsylvania. It is the largest museum in the country dedicated to a single artist. The museum holds an extensive permanent collection of art and archives from the Pittsburgh-born pop art icon Andy Warhol. The museum is located in an 88,000-square-foot facility on seven floors. Containing 17 galleries, the museum features 900 paintings, close to 2,000 works on paper, over 1,000 published unique prints, 77 sculptures, 4,000 photographs, and over 4,350 Warhol films and videotaped works.

National Aviary

National Aviary

The National Aviary, located in Pittsburgh, is the only independent indoor nonprofit aviary in the United States. It is also the country's largest aviary, and the only accorded honorary "National" status by the United States Congress.
The aviary is home to over 600 animals representing about 200 species, and is a member of the Association of Zoos and Aquariums (AZA). The National Aviary has daily interactive experiences for visitors. Some of these include Penguin Point, a new exhibit featuring 11 African penguins and underwater viewing; Penguin Connection, a private encounter with an African penguin (for an additional fee); Little Peepers, a program for preschoolers; and the bird-feeding adventure Lories & Friends. These programs are joined by various trainer talks, bird presentations, feedings, and encounters that help to create an immersive experience for visitors.

PNC Park

PNC Park

PNC Park is a baseball park located on the North Shore of Pittsburgh. It is the fifth home of the Pittsburgh Pirates, the city's Major League Baseball (MLB) franchise. It opened during the 2001 MLB season, after the controlled implosion of the Pirates' previous home, Three Rivers Stadium. PNC Park features a natural grass playing surface and seats 38,362 people for baseball. The park also features a riverside concourse, steel truss work, an extensive out-of-town scoreboard, and many local eateries. Constructed faster than most modern stadiums, PNC Park was built in a 24-month span.

Carnegie Museum of Natural History

Carnegie Museum of Natural History

Carnegie Museum of Natural History, located at 4400 Forbes Avenue in the Oakland neighborhood of Pittsburgh, was founded by the Pittsburgh-based industrialist Andrew Carnegie in 1896. It is ranked among the top five natural history museums in the United States. The museum consists of 115,000 square feet organized into 20 galleries as well as research, library, and office space. It holds some 22 million specimens, of which about 10,000 are on view at any given time and about 1 million are cataloged in online databases.

Pittsburgh Zoo & PPG Aquarium

Pittsburgh Zoo & PPG Aquarium

The Pittsburgh Zoo is one of only six major zoo and aquarium combinations in the United States. Located in Pittsburgh, Pennsylvania's Highland Park, the zoo sits on 77 acres of park land where it exhibits more than 4,000 animals representing 475 species, including 20 threatened or endangered species. The Pittsburgh Zoo is divided into seven sections, each of which focuses on a particular theme. The Kid's Kingdom sector contains many interactive exhibits, such as the meerkat exhibit, which contains crawl-through tunnels that gives the viewer an idea of what it is like to be a meerkat or other burrowing animal. The animal yards and habitats in Kids Kingdom allow visitors to learn about animals' lives, behaviors, and points-of-view. Kid's Kingdom has been highly ranked by both Parent Magazine and America's Best Zoos Travel Guide.

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

We need below information to serve you better

Best Sellers
You Recently Viewed
    Loading