FALLS CHURCH, Va., Dec. 6, 2018 /PRNewswire-PRWeb/ -- Medical Device Voluntary Malfunction Disclosure Regulation Are You Up to Date on the Latest Developments? **An FDAnews Webinar** Tuesday, Dec. 18, 2018, 11:00 a.m. - 12:30 p.m. ET
https://www.fdanews.com/mdvoluntarymalfdisclreg?
Streamline the way malfunctions are reported.
The Voluntary Malfunction Summary Reporting Program allows manufacturers to report certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis instead of the typical 30 days for each individual report.
Over the course of 90 fast-paced minutes, Stephanie Resnik and Christopher Hanson, associates at Covington & Burling LLP, Washington, DC, will discuss which products are covered, how the program will help increase efficiency and whether it makes sense to take part in the program. Attendees will learn the following:
Meet The Presenters:
Stephanie Resnik, Associate, Covington & Burling LLP, Washington, DC Stephanie Resnik, an associate in Covington & Burling LLP's Washington, DC office, advises medical device, pharmaceutical, biotechnology, food, and tobacco companies on a variety of regulatory and compliance issues, including labeling, advertising, facility registration, CGMP compliance, and reporting requirements.
Christopher Hanson, Associate, Covington & Burling LLP, Washington, DC Christopher Hanson, an associate in Covington & Burling LLP's Washington, DC office, advises international and domestic clients on regulatory strategies and compliance for medical devices, pharmaceuticals, biological products, radiation-emitting electronic products, and clinical laboratories.
Who Will Benefit:
Tuition: $287 per site
Easy Ways to Register: Online: https://www.fdanews.com/mdvoluntarymalfdisclreg? By phone: 888-838-5578 or 703-538-7600
About FDAnews: FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
SOURCE FDAnews
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Streamline the way malfunctions are reported.
The Voluntary Malfunction Summary Reporting Program allows manufacturers to report certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis instead of the typical 30 days for each individual report.
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Over the course of 90 fast-paced minutes, Stephanie Resnik and Christopher Hanson, associates at Covington & Burling LLP, Washington, DC, will discuss which products are covered, how the program will help increase efficiency and whether it makes sense to take part in the program. Attendees will learn the following:
- Background of the Voluntary Malfunction Summary Reporting Program including:
- Origins of the program
- FDA's intentions in establishing the program
- Types of manufacturers, devices, and events eligible to participate in the program
- How the Voluntary Malfunction Summary Reporting Program differs from individual malfunction reporting
- Benefits to device manufacturers including the efficiency advantages offered by the program
- Conditions under which the program is not available to manufacturers
Meet The Presenters:
Stephanie Resnik, Associate, Covington & Burling LLP, Washington, DC Stephanie Resnik, an associate in Covington & Burling LLP's Washington, DC office, advises medical device, pharmaceutical, biotechnology, food, and tobacco companies on a variety of regulatory and compliance issues, including labeling, advertising, facility registration, CGMP compliance, and reporting requirements.
Christopher Hanson, Associate, Covington & Burling LLP, Washington, DC Christopher Hanson, an associate in Covington & Burling LLP's Washington, DC office, advises international and domestic clients on regulatory strategies and compliance for medical devices, pharmaceuticals, biological products, radiation-emitting electronic products, and clinical laboratories.
Who Will Benefit:
- Quality Managers
- Quality Engineers
- Production Managers
- Production Supervisors
- Manufacturing Engineers
- Production Engineers
- Design Engineers
- Process Owners
Tuition: $287 per site
Easy Ways to Register: Online: https://www.fdanews.com/mdvoluntarymalfdisclreg? By phone: 888-838-5578 or 703-538-7600
About FDAnews: FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
SOURCE FDAnews
