10:00 a.m. – 10:15a.m. |
Introduction to the Virtual Conference |
10:15 a.m. – 11:00 a.m. |
Servicing Can Lead to Complaints — an In-Depth Look at 21 CFR 820.200 The FDA cites the quality system regulations 21 CFR 820.200 in warning letters that connect service reports to what it considers an unreported complaint. The regulation says that each manufacturer must create and maintain procedures for each time they service a device. This presentation will review statistical techniques that can be used to analyze service reports. Some of these techniques include: scatter plots, check sheets, Pareto charts, and cause-and-effect diagrams. Attendees will:
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11:00 a.m. – 11:15 a.m. |
Morning Break |
11:15 a.m. – 12:00 p.m. |
Two Sides of the Same Coin: Analyzing the Definition of a Complaint in 21 CFR 820.198 and ISO 13485 Attendees will:
Susan Reilly, Owner and Principal Consultant, Reilly & Associates, LLC |
12:00 p.m. – 12:45 p.m. |
EMDR Update: The FDA’s Current Thinking on eMDRs The FDA has been encouraging the use of eMDRs in recent years and is moving toward making eMDRs the rule and not the exception. The proposed rule, published in August, would require all device manufacturers to submit medical device reports (MDRs) electronically. During this session, Brandi Stuart, acting Chief of the Information Analysis Branch, will discuss where eMDRs are and where they are going.
Brandi Stuart, acting Chief of the Information Analysis Branch, CDRH FDA |
12:45 p.m. – 1:45 p.m. |
Lunch Break |
1:45 p.m. – 2:30 p.m. |
Front Line Employees — Recognizing Customer Interactions as Complaints Attendees will:
John Talarico, Sr. VP Quality Systems and Regulatory Affairs, Delcath Systems |
2:30 p.m. – 3:15 p.m. |
5-day or 30-day Report? Understanding MDR Under 21 CFR 803 Attendees will learn:
Edward Wilson, Partner, Hogan & Hartson |
3:15 p.m. – 3:30 p.m. |
Afternoon Break |
3:30 p.m. – 4:15 p.m. |
CDRH’s Proposed Rule On eMDRs to Be Made Mandatory, Are You Ready? Attendees will:
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4:15 p.m. – 5:00 p.m. |
Managing Corrections and Removals – Living Up To 21 CFR 806 Attendees will learn:
Dan
O'Leary, President, Ombu Enterprises |
How does this virtual conference work?
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The Medical Device Complaint Systems Virtual Conference takes all the best elements of the best live conference you’ve attended and avoids all the negatives. It delivers valuable clinical trial development intelligence using the internet for visual components and your speakerphone for the accompanying audio.
All you do is go to the specified website on the day of the event and dial the specified toll-free telephone number, both provided in your registration confirmation. That’s all there is to attending.
Then, relax at your desk or in your conference room, enjoying summit sessions featuring PowerPoint slide presentations, helpful handouts and Q&A opportunities where specific attendee questions will find direct answers from leading supply chain professionals.
What are the top benefits of a virtual conference?
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Highly effective communication: This event uses internet and audioconferencing to create a seamless interface and deliver vital compliance and management advice using technology found in every workplace.
Great value: Select as many of your colleagues to attend as you wish and educate everyone for one low price, with no travel, lodging or per diem expenses.
Stress-free: No hotel or airport nightmares because you never have to leave your building. You’ll feel like you’re off-site at a top-flight conference, until you realize how easy it is to get things done during breaks.
Efficient: You can assign your staff to different sessions. Staffers can go to the sessions that most pertain to their responsibilities.
Content-rich: This virtual conference addresses your most challenging, complex and frustrating supplier quality problems.
Interactive: No one-way street, you’ll have plenty of opportunities to ask questions and get involved.
Up to the minute: This program will be up to the minute with the latest changes initiated by the FDA and international regulatory bodies incorporated into the event.
Comprehensive: You’ll hear from six industry experts all in the course of one day.
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