Post-Market Compliance for Medical Devices and Evolving Reporting Requirements: Complaint Handling, MDR/eMDR and Recalls including UDI update: One and a Half-day In-Person Seminar by Ex-FDA Official
Rita Hoffman, RAC, Managing Partner Regs & Recall Strategies, LLC and Former FDA CDRH Recall Branch Chief
Thursday, August 6, 2015 | Friday, August 7, 2015
St. Louis, MO
Thursday, October 15, 2015 | Friday, October 16, 2015
Los Angeles, CA
Thursday, November 5, 2015 | Friday, November 6, 2015
||Course "Post-Market Compliance for Medical Devices and Evolving Reporting Requirements: Complaint Handling, MDR/eMDR and Recalls including UDI update" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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.
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.
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.
- 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.
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
- Project Managers
- Regulatory Professional
- Risk Managers
- Complaint Handling Teams
- CAPA Teams
|Conference Day One (8:30 AM – 5:00 PM)
||Conference Day Two (8:30 AM – 12:00 PM)
- Registration Process: 8:30 AM - 9:00 AM
- Session Start: 9:00 AM
- 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
- 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)
Meet Your Instructor
||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.
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Minneapolis, MN (Venue to be announced shortly)
August 6-7 2015
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October 15-16, 2015
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November 5-6, 2015
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Minneapolis, MN, Local Attractions
Los Angeles, CA, Local Attractions
Cathedral of St. Paul
Built in 1915 on the highest point in the city, this cathedral is one of the largest in the country. A replica of St. Peter's in Rome, the building boasts a newly restored 175-foot-high copper dome, a massive rose window, and granite-and-travertine construction.
Frederick R. Weisman Art Museum
Set on a bluff overlooking the Mississippi River, the Weisman Art Museum is part of the University of Minnesota campus. You won't miss the trademark Frank Gehry-designed building; its fluid form defies conventional architectural lines, and its metallic finish gleams in the sunlight. The permanent collection is especially strong in American modernist paintings, ceramics, Mimbres pottery, and Korean furniture.
Historic Fort Snelling
This living history museum commemorates the establishment of a fort here in the wilderness in 1819 by Col. Josiah Snelling and his troops, who opened the area for homesteaders. Costumed guides are the focus of a living history reenactment during the summer months, re-creating the activities of everyday army life during the 1820s.
Mill City Museum
Minneapolis's Mill City Museum recounts the history of the flour industry that earned the city the nickname "Mill City" in the late 19th century. Set in the ruins of what was once the world's largest flour mill the museum re-creates old milling techniques with period equipment railroad cars and interactive exhibits. Visitors also learn the impact of the nation's first high-quality finely milled flour on the gastronomy of the Twin Cities and the country.
Minneapolis Institute of Arts
More than 5,000 years and 80,000 pieces of fine and decorative arts comprise the permanent collection at the MIA, including a 2,000-year-old mummy, European masters (Rembrandt, Titian, and Monet, among others), architectural and decorative arts, and a comprehensive photography exhibit. If you're short on time, ask for the "Highlights" brochure to make sure you don't miss the museum's best.
Minnesota History Center
An impressive array of artifacts is housed in this three-story museum, including photographs, music, and videos, all of it celebrating Minnesota history. Kids enjoy sitting in the re-created basement of a Minnesota farmhouse while a simulated tornado passes overhead. Adults enjoy listening to recordings of Minnesota musicians, including Bob Dylan, Steven Greenberg, and Prince.
Minnesota Museum of American Art
Temporary exhibits are the rule at the Minnesota Museum of American Art, which overlooks the Mississippi River. Expect edgy, contemporary installation pieces, as well as paintings, fiber art, ceramics, works on paper, and works created from found objects.
"Russia's Grizzly Coast" became the Minnesota Zoo's newest exhibit in 2008 bison pumas and wolverines -- as well as exotic mainstays like tigers camels dolphins and monkeys. The Minnesota Zoo also includes an IMAX theater and a monorail for easy navigation of the grounds.
Mississippi River Visitor Center
Located inside the entrance to the Science Museum of Minnesota , the Mississippi River Visitor Center is operated by the National Park Service and designed to educate visitors about the Mississippi National River & Recreation Area. Park rangers can assist travelers with planning outdoor excursions, including canoe and riverboat trips, hiking, biking, and birding. If you're at all outdoorsy, it's worth a stop.
Science Museum of Minnesota
Hands-on exhibits introduce visitors to natural history, science, and technology in this massive museum. Highlights include the Human Body Gallery, navigating a virtual towboat down the Mississippi River, and a collection of fossils and prehistoric specimens. In warm months check out EarthScapes Mini Golf, a new activity designed to teach earth surface dynamics. There's also an Omnitheater.
Griffith Observatory is an icon of Los Angeles, a national leader in public astronomy, a beloved civic gathering place, and one of southern California's most popular attractions. The Observatory is located on the southern slope of Mount Hollywood in Griffith Park, just above the Los Feliz neighborhood. It is 1,134 feet above sea level and is visible from many parts of the Los Angeles basin.
Universal Studios Hollywood
Universal Studios Hollywood is a movie studio and theme park in the Los Angeles County, California, United States. It is one of the oldest and most famous Hollywood movie studios still in use. Its official marketing headline is "The Entertainment Capital of LA", though during the summer it is often advertised as "The Coolest Place in LA. It is the first of many full-fledged Universal Studios Theme Parks located across the world.
Los Angeles County Museum of Art
The Los Angeles County Museum of Art (LACMA) is the largest art museum in the western United States. It attracts nearly a million visitors annually. Its holdings of more than 100,000 works span the history of art from ancient times to the present. In addition to art exhibits, the museum features film and concert series.
Beverly Center Shopping Mall is a large indoor shopping center located near Beverly Hills. Beverly Center is Southern California's premier fashion destination with over 100 distinctive specialty boutiques reflecting the diverse styles and tastes of Los Angeles. The Center is anchored by Bloomingdale’s, Macy’s and the upscale dining destination, The Capital Grille.
Venice Beach is a seaside neighborhood of Los Angeles. Named for its series of canals, Venice is known as a haven for creative types. It is famous for its bohemian boardwalk and for the eclectic Abbot Kinney Blvd. Venice Beach include the beach, the promenade that runs parallel to the beach (“Ocean Front Walk” or just “the boardwalk”), Muscle Beach, the handball courts, the paddle tennis courts, Skate Dancing plaza, the numerous beach volleyball courts, the bike trail and the businesses and residences that have their addresses on Ocean Front Walk.
Los Angeles Zoo and Botanical Gardens
The Los Angeles Zoo and Botanical Gardens is located in Los Angeles Griffith Park. The Zoo is home to more than 1,100 mammals, birds, amphibians and reptiles representing more than 250 different species of which 29 are endangered. In addition, the Zoo’s botanical collection comprises several planted gardens and over 800 different plant species with over 7,400 individual plants. The Zoo receives over 1.5 million visitors per year.
Staples Center is a multi-purpose sports arena in Los Angeles. It is one of the major sporting facilities in the Greater Los Angeles Area. The arena is home to the Los Angeles Lakers and the Los Angeles Clippers of the National Basketball Association (NBA), the Los Angeles Kings of the National Hockey League (NHL), and the Los Angeles Sparks of the Women's National Basketball Association (WNBA).
The Watts Towers are a complex set of 17 separate sculptural pieces built on a residential lot in the community of Watts. Two of the towers rise to a height of nearly 100 feet. The Watts Towers are one of only nine works of folk art listed on the National Register of Historic Places. The site is one of only four US National Historic Landmarks in the city of Los Angeles.
The Center houses a comprehensive collection of Western art from medieval times to the present, with particular strengths in alchemical texts, Italian futurism, Russian Modernism, Japanese avant-garde art and artists’ letters and sketchbooks throughout the ages. The Center’s campus features numerous garden spaces, fountains and pools as well as outdoor sculptures. The center draws 1.3 million visitors annually.