FDA IVDR and UDI Regulatory Compliance Presentation

Those in the northeast, get ready! Not only will R&Q be exhibiting at this year's BIOMEDevice show (booth 640) and sponsoring MassMEDIC's Annual Conference, but we'll be presenting an afternoon training workshop (three separate sessions) free to attendees of the BIOMEDevice show on Wednesday, April 13th from 1:00 - 4:00pm. The event will cover compliance, IVDR, and UDI... and you can choose to attend whichever session(s) you like. This will be one of R&Q's premier education events of the year and we're incredibly excited about the team we'll have on hand to share their expertise and experience, moderate discussion, and field questions. Keep on reading for complete details.

Those who plan to attend should reserve their seat in advance. Even if you're planning on attending only one of the sessions, you'll still need to sign up. If you're headed to to the MassMEDIC Annual Conference in the morning this is the perfect way to spend your afternoon!

What?

An Afternoon Workshop Presented by Regulatory and Quality Solutions (R&Q)
What You Need To Know: Timely and Requisite Guidance on Compliance, IVDR, and UDI

Agenda

1:00 - 2:00pm
For Manufacturers and Contract Manufacturers: Practical Considerations for Avoiding FDA Compliance Problems, and How to Manage Them If They Arise

Jake O’Donnell, Senior FDA Compliance Principal, Regulatory and Quality Solutions (R&Q)
Paul Robinson, Regional Director Operations, Regulatory and Quality Solutions (R&Q)

In this session you will learn from a former FDA consumer safety officer of 20 years what it takes to proactively improve your systems to avoid problems, and proficiently manage issues if they happen to occur. First-hand experiences of how R&Q helped remediate projects will be shared, and best practice strategic and tactical solutions will be given for how to avoid those situations in the first place. We’ll also investigate emerging oversight trends, common problems, classic times in business cycle when compliance issues arise, and other specific challenges.

Click Here to Sign Up

2:00 - 3:00pm
What Nobody's Telling You About IVDR: Tomorrow's Tasks are Actually Today's

Christine Santagate, RAC, Client Solutions Advisor Regulatory and Quality Solutions (R&Q)

There’s more to be aware of than you might think. In this session you will learn what you need to do to fulfill the new IVDR requirements. This includes the importance of monitoring not only the FDA, but the US Congress and CMS, and the EU MDR and the International Medical Device Regulatory Forum (IMDRF). In addition to strategy preparation for changes in the US and EU, we’ll explore the potential impact on IMDRF countries. We’ll also discuss long term strategic planning for device, including those that may require clinical trial or that fall outside of traditional agency authorities.

Click Here to Sign Up

3:00 - 4:00pm
A Whole New World of UDI: How To Seamlessly Comply with the FDA Now While Preparing for the Global Requirements of the Future

Paul Robinson, Regional Director Operations, Regulatory and Quality Solutions (R&Q)

Surprisingly, about 50% of medical device companies have not yet started implementing the requirements for UDI compliance. Have you? And if you have, what are you plans regarding the expanding UDI global requirements? With some deadlines in the rearview mirror and others rapidly approaching, standing still is not an option. Using real-world experiences, this session will offer strategic advice for complying with UDI in the US and around the world, including compliance dates, detailed task planning, and other specific needs you’ll need to meet – and perhaps most importantly, pitfalls to avoid. Whether you are ahead of the UDI game or have waited until the eleventh hour, this session will offer a combination of basic and advanced information that anyone dealing with UDI cannot pass up. Be compliant, and be on time.

Click Here to Sign Up

When?

Wednesday, April 13th
1:00 - 4:00pm (three separate sessions - can attend one, two, or all three)

Where?

Boston Convention & Exhibition Center
Boston, MA
Room TBD (this post will be updated)

Sign Up!

Let us know you'll be there be signing up through BIOMEDevice below. Even if you plan to only attend one or two sessions instead of all three, you'll need to sign up.

Click Here to Sign Up

 

BONUS: Spot Our Ad, Show Us at the Workshop, Win a Gift Card

If you are signed up for our workshop, find our ad in the BIOMEDevice event guide and show a member of our team. We'll enter you in a drawing for an Amazon gift card. We'll be giving away several gift cards at the conclusion of the final session (4:00pm), so take a close look at the event guide and be sure to attend!

Regulatory and Quality Solutions Workshop Poster

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