Join industry thought leaders for our 3rd Thursday Lunch & Learns!
Advance your awareness of the driving forces you manage every day so you can lead with wisdom that would otherwise take a career to gain. Gain insights for a lifetime during these 30 minute informative, insightful webinars.
Upcoming February Webinar: Integration Success – Successful Practices from Other Industries Thursday, February 16 from 12:00 - 12:30 pm
Aligning with an external organization through contract operations, supplier relationships, mergers and acquisitions goes beyond FDA regulated industries – and has existed for decades. Michael Taylor, co-founder and CEO of Schellingpoint, will share insight from multiple industries that he has gained through the Schellingpoint Alignment Optimization process, which is a sophisticated methodology based on the Nobel Prize winning algorithms of Thomas P. Schelling. Through the Alignment Optimization process, Michael has identified trends of obstacles and successful practices that gives us a greater chance to achieve “Right First Time” in our FDA regulated industries. We will explore the following questions with Michael:
- Can you explain how the Alignment Optimization Process works?
- What trends of obstacles and successful practices have you observed across industries as organizations work to align on strategies, goals and expectations?
- What can the pharmaceutical and medical device industries do to prevent misalignment and maintain alignment throughout the relationship lifecycle?
Previously recorded webinar from February 16, 2017 Meet FDA’s Inaugural Ombudsman – Jessica Zeller
Jessica Zeller, JD is the newest FDA ombudsmen in a position that was created for the first time in the Office of Regulatory Affairs. In this position, Jessica serves as an impartial voice to bring FDA and external parties toward a common understanding (often referring to herself as a translator). This newest position is instrumental in bridging gaps that might have existed for decades, as the Office of Regulatory Affairs houses all of the investigators across the country. Join us for a live interview of Jessica as we explore the following questions:
- Can you explain the roles of the ombudsmen across the FDA, and why your role was created in ORA?
- What is your reporting structure, and how is information kept confidential? (Should Industry fear retribution?)
- You handle many different kinds of issues. Can you explain what impact you have in those situations? (How does industry benefit from calling you?)
- Having been in industry, what do you feel prevents companies from utilizing your services?
Previously recorded webinar from January 19, 2017 How FTC Operations Impact Industry and Consumers
Jon Miller Steiger, Director of the East Central Region of the Federal Trade Commission, will share insight with us on FTC operations that will expand our awareness of the industry ecosystem, as well as provide an understanding from a consumer standpoint as to areas of protection and vulnerabilities that exist. Jon will explore the following questions:
- Which areas are regulated by FTC?
- When and how does FDA and FTC authority differ – as well as where their paths cross?
- What challenges exist for the FTC related to enforcing the laws on drug, device and homeopathic products?
- How will the Trump Administration impact Federal Trade Commission Operations?
Previously recorded webinar from December 15, 2016 Presidential Elections - Impact on the FDA
As the nation prepares itself for a new presidential administration to take-over the white house, John Taylor (former counselor to FDA Commissioner Hamburg) and Steve Niedelman (former FDA Deputy Associate Commissioner of Regulatory Affairs) delve into the intricacies of how presidential changes impact the FDA.
The following questions will be explored:
- Which FDA positions are political appointments that typically change with the election of a new president? And what Congressional hurdles need to be overcome for the appointments to be confirmed?
- What FDA operations and policies are of interest to new Administrations and why?
- Does a new Administration and new FDA leadership make different strategic choices based on which party or parties are in control of Congress?
- Based on campaign speeches, are you able to speculate on the impact President Trump will have on FDA operations?
- How will the new election impact the reauthorization of the four user fee programs?
View Slides Here: Taylor and Niedelman – Presidential Elections – Impact on the FDA
Previously recorded webinar from November 17, 2016 Dangerous Documents: Avoiding Land Mines in Your FDA Records and Emails
Former U.S. Department of Justice Prosecutor and Defense Lawyer, Nancy Singer, will open your eyes to the danger and harm that seemingly innocuous emails and documents can have on your career and for your organization. Through real case study examples from our industry, you will have a deeper appreciation of how to survive in our litigious society. Nancy will demonstrate how to communicate in ways such that your facts, issues and actions won’t be misinterpreted. She will explain how to set up a program to change your organization’s culture. Just remember, your emails can be retrieved indefinitely, so don’t miss this opportunity to set you and your organization up for success.
Previously recorded webinar from October 20, 2016 FDA Shared Inspections on the Horizon - Risks, Benefits and Impact
Kim Trautman is the foremost expert on where FDA is going with a shared inspection model. She has led FDA efforts in the Medical Device Single Audit Program (MDSAP) development with other recognized regulatory authorities since its inception. While in FDA, she spearheaded this work with her international regulator colleagues by chairing the MDSAP Working Group for the International Medical Device Regulators Forum. Now in her role as Executive Vice President for NSF International, Kim will candidly share what she sees as the benefits and risks of this program to FDA, the benefits and risks of this program to industry, and the hurdles that have to be overcome in order for this program to succeed. Join us for this captivating interview as Kim provides a glimpse into the future of FDA shared inspections.
View Slides Here: Kim Trautman – Shared Inspections 2016 10 20
Previously recorded webinar from September 15, 2016 Top 3 Supply Chain Risks and Opportunities - From a Supplier's Perspective
As the Global Director of Quality for JM Huber Engineered Materials, Dale Carter shared paradigm shifting insight on areas of unexpected breakdown in supply chain control – from the viewpoint of a supplier. Through his 28 years of experience, working with over 1400 customers on every continent, and serving as an active team member on several industry-wide global supply chain initiatives (IPEC (past Chair), NSF International Joint Committee of Pharmaceutical Excipients, EXCiPACT Operations Board, and the Xavier Integrity of Supply Initiative), Dale shared actionable insight on the realities of supplier relationships, including:
- How your risk can be reduced if suppliers understand how you intend to use their materials
- Access you can have to supplier variability information…if you just ask
- How your own operations increase supplier risk
View Slides Here: Dale Carter – Supply Chain Risk 2016 09 15 rev4
Previously recorded webinar from August 18, 2016 The World of FDA Metrics: Yesterday, Today and Tomorrow
During this Xavier Lunch & Learn session, Marla Phillips (Director, Xavier Health and former Head of Quality, Merck NC Facility) provided an insider’s view on the differences and similarities across the CDER and CDRH metrics initiatives. Marla co-led with FDA the CDRH Metrics Initiative and co-led with PricewaterhouseCoopers a pharmaceutical metrics initiative. Marla addressed:
- Why there are differences between the CDER and CDRH metrics initiatives
- The progress of both initiatives
- Input from industry on what industry wants from FDA
- Current thinking on how metrics can be used by FDA
- Opinions on how metrics should not be used by FDA
View Slides Here: Marla Phillips – The World of FDA Quality Metrics.August 2016
View Xavier/PwC Pharmaceutical Metrics White Paper: Xavier University – PwC Pharmaceutical Metrics White Paper.January 2016
View MDIC FDA/Xavier Device Metrics White Paper: MDIC Medical Device Quality Metrics Best Practices.August 01 2016
Previously recorded webinar from July 21, 2016 Differences in FDA Legal Authority Across Commodities
From John’s experience in FDA as the Counselor to the Commissioner, he provided insight on the why’s behind the differences across commodities for:
- FDA Mandatory Recall Authority
- FDA Allocation of Resources
- Mutual Reliance
- Import Authority
- FDA Inspectional Authority
View Slides Here: John-Taylor-FDA-Authority.July-2016
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