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
Location 1 :-
Thursday, June 11, 2015 | Friday, June 12, 2015
Thursday, August 6, 2015 | Friday, August 7, 2015
St. Louis, MO
Thursday, October 15, 2015 | Friday, October 16, 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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August 6-7 2015
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Chicago, IL, Local Attractions
Minneapolis, MN, Local Attractions
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
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
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
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.
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.