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, filing for both Medical Device Reports (MDR) and eMDR, effective and appropriate communication with the appropriate regulatory agencies in the event of a recall and how UDI's factor into reporting. She will discuss, all the new FDA Guidance's that have issued in 2016 discussing FDA's thoughts on firms processes for MDR Reporting, a correction and removal action to avoid a recall crisis, including required recordkeeping, expectation from an FDA perspective on achieving regulatory compliance. In addition, she will provide key factors in implementing and maintaining compliance with the regulations from real life experiences of FDA.
Medical Device Reporting (MDR) and the implementation of the Final Rule on eMDR and recall compliance are critical to the continued 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. Ineffective or lack of proper Complaint Handling is cited as one of the top violations in a 483 issued at time of inspection by FDA. 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 and Final Rule on eMDRs & 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.
Who will Benefit
- Understand how to comply with complicated Compliant Handling, MDR, eMDR and Recall requirements
- Firms eMDR/ MDR reporting and FDA's handling of reports and UDI requirements for recalls
- 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
- Navigating the maze of New Draft and Final FDA’s Guidance’s with Post-compliance issues
- Quality Assurance and Quality Control personnel responsible complaint handling and recalls
- Regulatory and Compliance professionals responsible for FDA interactions
- Project Managers responsible for maintenance of Complaint Handling, troubleshooting, and understanding QSR
- Risk Managers
- CAPA Teams
- Complaint handling units
- Compliance officers
- Consultants/service providers
- Regulatory/legislative affairs professionals
- IT department supporting complaint handling
- Regulatory affairs reporting units
Rita Hoffman, RAC - Managing Partner Regs & Recall Strategies, LLC and Former FDA CDRH Recall Branch Chief
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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Mill City Museum
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The recreation center incorporates outing zones, trails, sculpture and the 53 foot falls.
The attractive feature of the park, Minnehaha Falls, was a pioneer photographed site in Minnesota that illustrates transportation, spearheading, and architectural themes.
The 167-acre of land stop is isolated into two principle divides: A bridge just above the falls, and trails that go down into the gorge on both sides, and another bridge below the falls, that trails continue along the creek. The creek goes through the upper area and after it drops at the falls, it flows through the lower glen for another three-fourths of a mile.
The Guthrie Theater located in Minneapolis, Minnesota, United States. The Guthrie's outline emerged out of Ralph Rapson's work with the Walker Art Center, and ideas the Walker was thinking about for a little assembly hall close to their gallery. The Guthrie Theater, established in 1963, is an attractive center for theater execution, creation, instruction, and expert preparing in Minneapolis, Minnesota. The outside of the building's dividers are canvassed in extensive boards which show an expansive wall painting of photos from past plays visible clearly during the night.
Cedar Lake Park
The Cedar Lake Park Memorial Grove is located to the northeast shores of Cedar Lake and one of the Chain of Lakes within the city of Minneapolis, Minnesota. The north side is covered by the Cedar Lake Trail and the BNSF Railway. The lake has a region of 169 acres of land (0.26 sq mi) and a most extreme profundity of 51 feet (16 m). The Cedar Lake Park is maintained by lake park association and the board of Minneapolis park. It has three separate ways: one for walkers, one for westward bicyclists and skaters, and another for eastward bicyclists and skaters each being around 2 miles in separation by the lake. Cedar Lake is likewise well known for paddling and swimming, with three authority swimming shorelines. Striking is "Hidden Beach", authoritatively named East Cedar Beach, situated on the upper east side of the lake.
Washburn Park Water Tower
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Eloise Butler Wildflower Garden and Bird Sanctuary
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Minneapolis Sculpture Garden
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Walker Art Center
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