Breakthrough Supply Chain Performance
Mar
12
8:00 AM08:00

Breakthrough Supply Chain Performance

Join us the day before the FDA/Xavier PharmaLink conference, for Breakthrough Supply Chain Performance, Tuesday, March 12, 2019, from 8am-4pm, at Xavier University.

Good Supply Practices (GSPs) attack the true root cause of the supply chain failures your organization has experienced! You now have the power to reduce your organization’s global supply chain disruptions and can advance your career by protecting your organization and the patients you serve.

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FDA/Xavier PharmaLink Conference 2019
Mar
13
to Mar 15

FDA/Xavier PharmaLink Conference 2019

The PharmaLink conference seeks solutions to important and complicated issues by aligning with the strategic priorities of the Food & Drug Administration. We help participants create links to drive new thinking. The solutions might not be evident within our industry, so we explore beyond our industry, beyond borders, and beyond comfort zones.

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FDA/Xavier MedCon Conference 2019
Apr
30
to May 3

FDA/Xavier MedCon Conference 2019

MedCon brings the global medical device community together to openly discuss the most pressing issues facing our industry. You have the opportunity to influence decisions and have your voice heard as you interact with leading FDA officials and field investigators, along with global industry experts.

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Combination Products Summit 2019
Sep
11
to Sep 13

Combination Products Summit 2019

Combination Products Summit brings the global combination products community together to openly discuss the most pressing issues facing our industry. Influence decisions and have your voice heard as you interact with leading FDA officials and field investigators, along with global industry experts.

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Combination Products Post-Summit Workshop
Sep
14
8:00 AM08:00

Combination Products Post-Summit Workshop

Join us for this intermediate-level Post-Summit Workshop. The workshop team, industry thought-leaders who have worked closely with FDA officials and industry associations to collaboratively shape the direction of the combination products industry, will explore real-world challenges you are facing, provide answers and successful practices, and real steps you can take to reduce risk to your company, products and patients.

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Combination Products Summit 2018
Sep
12
to Sep 13

Combination Products Summit 2018

Combination Products Summit brings the global combination products community together to openly discuss the most pressing issues facing our industry. Influence decisions and have your voice heard as you interact with leading FDA officials and field investigators, along with global industry experts.

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FDA/Xavier MedCon Conference 2018
May
1
to May 4

FDA/Xavier MedCon Conference 2018

MedCon brings the global medical device community together to openly discuss the most pressing issues facing our industry. You have the opportunity to influence decisions and have your voice heard as you interact with leading FDA officials and field investigators, along with global industry experts.

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Case for Quality Workshop
May
1
11:30 AM11:30

Case for Quality Workshop

As the Case for Quality pilot nears the halfway point, CDRH would like to engage industry members in a workshop: by providing your input to FDA on the latest updates on the voluntary Case for Quality pilot study; discussing the benefits of the preliminary outcomes from the voluntary pilot study with FDA and your industry colleagues; engaging with FDA and your industry colleagues to develop ways to help expand the applicability of the pilot; and participating in developing the strategy for next steps.

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FDA/Xavier PharmaLink Conference 2018
Mar
14
to Mar 16

FDA/Xavier PharmaLink Conference 2018

The PharmaLink conference seeks solutions to important and complicated issues by aligning with the strategic priorities of the Food & Drug Administration. We help participants create links to drive new thinking. The solutions might not be evident within our industry, so we explore beyond our industry, beyond borders, and beyond comfort zones.

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January Lunch & Learn Webinar
Jan
18
12:00 PM12:00

January Lunch & Learn Webinar

Why "Quality" Doesn't Matter: The pharmaceutical and medical device industries have struggled for decades to improve quality, gain joint ownership of quality across functions, be valued by senior leaders and cross functional partners, reduce enforcement actions, and improve trust with global regulators. Have we, as an industry, achieved these goals? Learn the answer to this question, and many others, during this free webinar.

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November Lunch & Learn Webinar
Nov
16
12:00 PM12:00

November Lunch & Learn Webinar

The Future of Quality Operations through Artificial Intelligence: FDA, pharma and device came together for the first time in August of 2017 at the Xavier AI Summit to explore together how Artificial Intelligence can advance quality operations into the future...today. Xavier formed two working teams through the summit to explore solutions for industry-wide adoption of AI in quality operations. Learn firsthand what the excitement is all about during this free webinar.

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Cybersecurity Summit 2017
Oct
24
to Oct 25

Cybersecurity Summit 2017

Join FDA and industry thought-leaders at a collaborative meeting of the minds addressing the most pressing challenges that threaten the quality assurance of our products and expose patients to life-threatening risks. FDA identifies this one-of-a-kind summit as “important,” enabling participants to walk away with actionable solutions. test

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Cincinnati Regional Chapter Kick-Off Meeting
Oct
11
8:30 AM08:30

Cincinnati Regional Chapter Kick-Off Meeting

Become a Cincinnati Regional Chapter member, then join us at the Kick-Off Meeting. Xavier Health Director Marla Phillips will share how Xavier, FDA, and industry are working together in pharmaceutical and medical device metrics; global Good Supply Practices (GSPs); the future of quality operations through the power of AI; and “The Last Mile” of the supply chain.

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September Lunch & Learn Webinar
Sep
21
12:00 PM12:00

September Lunch & Learn Webinar

FDA officials, Captain Brenda Stodart (CDER Director of Small Business and Industry Assistance Program), and Elias Mallis (CDRH Director Division of Industry and Consumer Education), will share with you all the resources they have available for industry access every day. These resources include FDA web training, conferences and workshops, education series, and incredible links to pertinent information you need. Join us as for our free webinar, as we interview Elias and Brenda to find out how you can best take advantage of learning directly from FDA.

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Combination Products Summit 2017
Sep
11
to Sep 13

Combination Products Summit 2017

Bringing the global combination products community together to openly discuss the most pressing issues facing our industry. Influence decisions and have your voice heard as you interact with leading FDA officials and field investigators, along with global industry experts.

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July Lunch & Learn Webinar
Jul
20
12:00 PM12:00

July Lunch & Learn Webinar

The Next “Big Cure” is Here and Waiting: How Can Your Company Benefit? How Can You Benefit: Jason Barkeloo, Chairman and Founder of Opentherapeutics will share shocking information that will be upsetting to know people we love could have been cured, and exciting to feel a renewed sense of rigor for the pharmaceutical pipeline that has only been trickling over the past 15 years.  

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June Lunch & Learn Webinar
Jun
15
12:00 PM12:00

June Lunch & Learn Webinar

In today’s world, we are facing unprecedented dynamics as five generations of employees are present in the workplace. Dr. Linda Gravett will share: who the generations are, what motivates each of them, misconceptions that exist about them, and what concerns they have about each other in this free webinar.

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