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Ooh, I’ve got a good one for you today: An FDA regulator is giving a special 90-minute webinar for Greenlight Guru and the Medical Devices Group. Shout out to Jon Speer for arranging.

Your free registration at https://medgroup.biz/case-quality.

Francisco Vicenty is the FDA Case for Quality Program Manager. You may be familiar with his work.

FDA launched the “Case for Quality” (CfQ) in 2011 after reviewing device quality data and feedback from FDA and industry. They flagged widespread manufacturing risks that impact product quality.

The presentation will emphasize the areas of focus that, when properly executed, give you fantastic benefits: Higher productivity, fewer complaints, fewer CAPAs and investigations, and lower quality-related product costs than your competitors.

They’ll cover:
• What CfQ is and how FDA is engaging;
• Summary detail on CDRH pilot programs;
• How FDA is rethinking regulations.

You’ll be able to ask FDA questions – anonymously, if you like – during the call. So, while you can get the replay later, this might be a good one to attend live, Wednesday, July 11, starting at 11:45 a.m. New York time.

P.S. We only have 500 seats so register now at https://medgroup.biz/case-quality and forward this announcement to your colleagues.

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𝗖𝗛𝗔𝗡𝗚𝗘 𝗢𝗙 𝗣𝗟𝗔𝗡𝗦
I changed the date and location for October’s “10x for Engineers.”

When: October 10-12, 2018
Where: Hyatt Regency Mission Bay Spa and Marina (it’s really nice)

𝗢𝗨𝗥 𝗞𝗘𝗬𝗡𝗢𝗧𝗘 𝗦𝗣𝗘𝗔𝗞𝗘𝗥: Lance Black MD, the Med Device Innovation Lead at Texas Medical Center, the world’s largest med center on:
Hᴏᴡ ᴛʜᴇ ᴡᴏʀʟᴅ’s ʟᴀʀɢᴇsᴛ ᴍᴇᴅɪᴄᴀʟ ᴄᴇɴᴛᴇʀ ɪɴᴠᴇsᴛs ɪɴ ᴍᴇᴅɪᴄᴀʟ ᴅᴇᴠɪᴄᴇ ɪɴɴᴏᴠᴀᴛɪᴏɴ (ᴀɴᴅ ʜᴏᴡ ʏᴏᴜ ᴄᴀɴ ʙᴇɴᴇғɪᴛ!)

Locals, come at least for the keynote and reception.

• Prices 🔼 after July 4; full refund thru 8/16
• Four three-hour workshops
• Buy two registrations, get one free
• Yes to 🍨

https://medgroup.biz/10x

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Make it a great week.

Joe Hage
Medical Devices Group Leader

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Kyle Kruse
Improving and Scaling Medical & Industrial Technologies
Charlotte Bates

Norm Crawford
GDTP-S, Model Based Definition Specialist
This FDA case for quality webinar could be interesting. I just may have a few questions.

Mosa Alzowelei
Biomedical Engineer and Academic Counselor
Just registered for the Webinar, many thanks Joe Hage