Webinars

NOW AVAILABLE ON-DEMAND

Recalls, Market Withdrawals, Field Corrections, Safety Alerts 

 If there’s one thing common across manufacturing industries that companies can agree on, they hate recalls.

 There are so many internal quality, external market and unexpected supplier factors that can lead to the very difficult decision to pull back product from the market, or worse yet be told by the FDA to do so.  A product recall is potentially the most risk-laden situation a company can face and this risk is increasing, as supply chains grow more complex and the regulatory landscape becomes more robust.  Whether your business is Food & Beverage, Pharma, Medical  Device or Biopharm your company is vulnerable to these unfortunate events. In the least of cases, faulty products or contaminated foods are an inconvenience for the unlucky buyers. At worst, recalled products are linked to injuries, illnesses and even deaths. For manufacturers, recalls batter brand reputations, bottom lines and share prices.

Yet businesses can often underestimate the impact of a recall, the negative effect it can have, and the great amount of money and resources needed to manage it. It’s backbreakingly hard work. So how do you avoid such a costly and disruptive situation within your own company? Knowledge is power and in this webinar, we will take a closer look at the latest FDA guidance and trends regarding these sometimes avoidable situations and review some of the best practices to help manage them.

• Background on the latest FDA position and expectations for Recalls, Market Withdrawals and Safety Alerts
• Latest product correction trends and where most issues are occurring
• Future product recall complexity with the development of new technology (cyber risk, nanotechnology, 3D printing, etc.)
• Steps to ensure your procedures and processes contain the critical “gates” to help mitigate issues prior to distribution
• How best to manage these market activities, should they be required
• Why the post-recall management strategy is so critical for quick recovery

Speaker:
Tim Fischer, Principal Partner, Great Solutions, LLC


 

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The requirements for assessing irritation is now moved from ISO 10993-10 to ISO 10993-23 and with this new standard comes the inclusion of in vitro irritation testing. As we move further to reduce animal testing and incorporate the 3 R’s (replace, reduce, refine) into biocompatibility assessment for medical devices, this is a critical turning point. Join us for an intense and informative discussion on this standard and learn what steps to take to incorporate this testing into your biocompatibility program.

• Review of the in vitro testing method
• When to pursue in vitro or in vivo testing
• How to transition from in vivo to in vitro testing
• Current regulatory acceptance

• Objectives of the Presentation and Sources of Information
• How Big Is the Market? What’s the Growth Rate?
• Where is the Growth (or Decline) Coming From?
• The Impact of Covid
• Evolving Business Models—Growth of Service/Product Pairings
• New Settings For Medicine – Devices outside the Hospital/Doctors Office
• Rise of Non-Medical Companies in Medical Devices
• Four Most Significant Product Trends

• How Big Is the Supply Chain? What’s the Growth Rate?
• The Rise of the Mega Contract Manufacturer
• The Evolving Role of the Traditional and Smaller Suppliers
• New Opportunities for All Suppliers
• Warning Signs in the Supply Chain—Will You Be Shifted Away from the OEM?
• LCC Strategies vs. Automation in Developed Countries
• Other Than Price, What Will Matter to OEMs?

EUDAMED just kicked off! Ready? Set? Or Need to get started?
The EU Commission Decision for EUDAMED, the European Databank for Medical Devices (to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on invitro diagnostic devices is now live and effective from Dec 1st 2020.

The IT system consist of a total six modules, among which the first one is the Actor registration module. The European Commission, in agreement with the Medical Device Coordination Group (MDCG), is going to make available the different modules on a gradual basis as soon as they are functional. Meanwhile as an Economic Operator or a non-EU manufacturer, the EUDAMED database is to ensure the increase in transparency for medical devices and to improve coordination between member states.

Through this webinar, participants will be able to focus exclusively on “Actor Registration Module” which is key to accessing and using EUDAMED. Participants will learn how to proceed with actor and user registration and management, data to be stored, and the general validation process to receive an SRN.s.

Key Take-Aways:

1. Who are the ACTOR’s and what are their roles in EUDAMED.
2. What is meant by SRN and how to decode the SRN
3. Understand the Actor registration process
4. Different Modules of EUDAMED
5. Countries available in EUDAMED from December 2020
6. Person Responsible for Regulatory Compliance (PRRC) and their responsibilities in EUDAMED

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For medical device manufacturers and CMOs, the functions of planning, manufacturing, quality, safety, inventory management, procurement, and logistics are shifting from an emphasis of optimizing each discrete function to a more holistic cooperative approach that optimizes the end-to-end supply chain. A strong working relationship between suppliers and manufacturers not only delivers cost savings, it also minimizes inventory availability problems, production and shipping delays, as well as quality and safety issues—and that means a better product and more reliable services provided to your customers. Trust will lead to better relationships. And better relationships will lead to better business practices and growth.

Speakers:
 

• David Stephans, Chief Revenue Officer, Rootstock Software
• Nikki Willett, Chief Strategy Officer, ComplianceQuest
• Prashanth Rajendran, Chief Executive Officer, ComplianceQuest
• Lou Sanatore, Senior Solution Engineer, ComplianceQuest
• David Burton, Senior Solution Architect, Rootstock Software
• Bernal Rodriguez, CEO, ITEK

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The submission process to the FDA can be a stressful and uncertain time for a medical device company. Delays in getting your device to market can cost millions of dollars in revenue. Changes to standards, new guidance documents, and review variability all add to the stress of a submission. The FDA pre-submission process can help reduce the stress and answer questions related to your specific device. 

In this webinar we will cover what the pre-submission process is, how to initiate a meeting, and how to prepare and run the meeting to gain the best results. We will highlight tips we have used to make partnering with the FDA a rewarding experience. 

Join Thor Rollins and Matthew Jorgensen; PhD, DABT, as they cover:
 

• What is a pre-submission meeting (Q-sub) with the FDA?
• How do you set a Q-Sub?
• How do you deliver your plan during a Q-Sub?
• What is the meeting flow?
• Can I challenge the FDA?
• How do I get the most from the Q-Sub?

SPEAKERS:

Thor S. Rollins, B.S., RM (NRCM) 

Director, Toxicology and E&L Consulting, Nelson Labs

Matthew R Jorgensen, PhD, DABT 

Expert in Chemistry, Biocompatibility, and Toxicology for Medical Devices, Nelson Labs

• Quickly react and respond to the increased demand
• Empower their remote workforce
• Synchronize their supply chain
• Identify delays and bottlenecks in their manufacturing process
• Rearrange production schedule to meet delivery dates
• Ensure timely reviews of CARs, CAPAs and compliance documentation

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Porous polymers are the unknown science behind many of the products used in the fight against the COVID-19 pandemic. From diagnostic tests to UV disinfection chambers and countless other applications, the different types and functions of porous polymers can be used to improve product performance and flatten the COVID-19 curve.

Perfect for design and manufacturing engineers who have either a potential product concept or need to improve an existing product, this webinar will explore the science behind specific applications being used to flatten the COVID-19 curve and how to pick the materials most suitable for your design needs. Specifically, the following topics will be addressed and explored.
 

• Diagnostic testing components recommended by the CDC test protocol for COVID-19 sample collection and analysis

• Diagnostic testing components approved or in process with FDA to allow patient testing at the point of care

• Microporous PTFE solutions for UV reaction chambers to increase disinfection

• Foam solutions for N95 masks and other personal protection equipment (PPE)

• Infection prevention solutions for use in hospitals to prevent healthcare-associated infections of frontline healthcare workers and patients

• Ventilator component solutions that improve the safety, performance and patient outcomes of ventilator systems

• Filtration, wicking and venting solutions across blood management and drug delivery devices

NOW AVAILABLE ON-DEMAND

This webinar will bring together several members of industry to discuss the impact the COVID-19 pandemic has had on the medical device manufacturing supply chain. The panel will engage in a roundtable-style discussion to determine what damage has already been done, and what they expect in the months or even years ahead. Will the industry have a return to normalcy soon after the dust settles or will the effects of this linger for quite some time? Find out what these individuals foresee and pose your own questions to them to get their insights.

Speakers: 
 
Anthony S. Freeman, 
President, A.S. Freeman Advisors LLC
 
Todd McCaslin
Global Sourcing Director, Boston Scientific Corporation
 
Matthew Robida
Vice President of Corporate Development, Spectrum Plastics Group

Sean Fenske (Moderator)
Editor-in-Chief, MPO/ODT