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Implementation and Management of GMP Data Integrity
Danielle DeLucy
90 Min
Product Id: 705029
Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.
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FDA Inspections: Anticipation, Preparation, Reaction, Conclusion…Repeat
John Misock
120 Min
Product Id: 706557
FDA regulated industries can prophet by understanding the regulatory power of FDA and incorporating this knowledge into their daily routine. Time and resources spent preparing for the inevitable inspection will pay back proportionately. By doing your homework and putting simple principles to work you can minimize the negative effects of FDA’s power and put everyone in your organization at ease. By understanding the risks inherent in your products, you can develop a quality system that will align your operation with FDA’s expectations. Why live in fear when you can rest at night knowing you are ready?
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Medical Device Recalls - a Prevention Strategy
Charles H Paul
60 Min
Product Id: 706537
The rough breakdown of medical device failures is 60% residing with the product specification and only 30% of the errors in the components themselves. This rough breakdown indicates that most of the problems are referred to as management errors – caused by faulty systems, processes, and conditions. A failure of procedures and execution. In other words, management failure. In this webinar, learn the strategies to prevent such medical device recalls.
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Introduction to Root Cause Investigation for CAPA
Vanessa Lopez
60 Min
Product Id: 704409
This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation.
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Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation
Frank Stein
90 Min
Product Id: 706165
Attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in your current quality management system in a simple and quick way. This need smart ideas to reach the right level to pass the quality management audit by your certification company or notified body.
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Supplier and Service Provider Controls: FDA Expectations
Vanessa Lopez
120 Min
Product Id: 704844
This training program will provide regulatory requirements (US) of 21 CFR Section 820.50 (purchasing control) for the medical device industry and illustrate the same with examples. It will furnish details on what purchasing/supplier control management systems should address.
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Spotlight on Complaint Handling and Medical Device Reporting
Susanne Manz
90 Min
Product Id: 706099
This webinar will help you to understand the expectations of complaint handling and medical device reporting. You’ll also learn about lessons from 483s and warning letters. We’ll discuss how you can develop your processes to efficiently and effectively manage complaints and MDRs. Also, we’ll discuss how to link these processes to failure investigation, recalls, and CAPA (Corrective and Preventive Action). We’ll cover best practices, so you can be prepared for an FDA inspection.
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FDA Design and Document Change Control
Denise Arrington
90 Min
Product Id: 706555
Learn about change control process and procedures in regulated industries. This webinar help you understand and successfully apply change control steps and best practices.
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Audit 3.0: Audit/Auditing Fundamentals for the 21st Century
James W Monroe
60 Min
Product Id: 706495
Whether you are being audited or conducting and audit, understanding the fundamental is critical for both quality system and regulatory compliance. In this webinar we will examine the concepts of conducting audits and being the subject of an audit (internal or external).
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Successful 510(k) Submissions
John E Lincoln
60 Min
Product Id: 700815
In this 510(k) submission process webinar attendees will learn the different types of 510(k)s, 21 required elements in the traditional 510(k) and how are they addressed and documented. Also attendees will learn software / firmware requirements, De Novo submission for obtaining marketing clearance for medical devices in the U.S.
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Japan: Regulatory Compliance Requirements for Life Science Products
Robert J Russell
90 Min
Product Id: 702979
This training on Japanese regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.
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How to Create A PMS Plan and Report According to EU MDR 2017/745 Article 83-86?
Frank Stein
90 Min
Product Id: 706533
The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. One hot topic is the focus on the "Post-Market- Surveillance-Process" and the new requirements e.g. reporting to Competent Authorities and Notified Bodies and how this process is connected to other processes in the quality management system according to ISO 13485:2016. The understanding of these changes and how to implement changes until May 2021 is essential to keep your certificates and to keep the market entry open.
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GXP: Quality Standards and Regulations for the Medical Device Field
James W Monroe
60 Min
Product Id: 706494
This webinar will discuss and define GXP’s, where the variable “x”, is Laboratory, Clinical, or Manufacturing. The webinar will focus on the requirements for each, and how they relate to the total product lifecycle, compliance, and inspections.
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Responsible Person Article 15 EU MDR 2017/745 - A New Mandatory Role in Your Company Required by the EU MDR Regulation
Frank Stein
90 Min
Product Id: 706532
The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. One of those requirements is Article 15 Responsible Person for Regulatory Compliance. That role is a little bit similar to the role of the Qualified Person in the Pharma Industry but not the same and the new role is not the same as the Quality Representative for the quality management system. Your company must implement the new role in the organization structure and in the processes and take care of the qualification requirements.
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Implementing a Bullet Proof Quality System for FDA Audit Success
Meena Chettiar
60 Min
Product Id: 705400
This webinar will provide an overview of the FDA expectations in medical device industries for setting up a quality system for FDA audit readiness. It will also provide an understanding of the quality system inspection techniques (QSIT) requirements for documents controls, production and process controls, packaging and labeling controls and more.
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Medical Device Emerging Markets - Market Access & Obstacles
James W Monroe
60 Min
Product Id: 706493
This webinar will focus on "non-traditional" medical device markets, challenges to market access including competitors and government regulation or lack thereof. Outside of the most developed countries, there are many areas in the world, not as developed, where registration and marketing of medical devices is extremely lucrative. These include: Latin America (LATAM), Asia Pacific (APAC), and The Middle East (EMEA).
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Software as Medical Device: Artificial Intelligence/Machine Learning
James W Monroe
60 Min
Product Id: 706461
This session will focus on conducting a risk/benefit analysis of both the positive and potential negative impact of the advancement of AI and ML devices in the medical device industry. It will provide a further understanding of the FDA's current thinking on the implementation of regulatory policies to ensure safe and effective medical devices that advance the quality of life of the patient. Artificial intelligence technology is rapidly spreading across the medical field, as systems are being developed that can identify signs of illness and disease in a wide variety of imaging situations such as MRI and CT. AI devices are complex with respect to algorithm used in their development, information being input in to the systems in which they learn, and the recommended out from such learning.
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FDA and MHRA Guidance during the COVID-19 Emergency: Medical Devices and Diagnostic Tests
Mark Powell
60 Min
Product Id: 706478
This webinar pulls together current US FDA and UK MHRA guidance covering medical devices and diagnostic tests during the current COVID-19 emergency. Particular emphasis will be given to ventilators and other respiratory aids within the medical device topic.
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Total Product Life Cycle Development (TPLCD)
James W Monroe
60 Min
Product Id: 706460
This webinar will discuss the multi-faceted aspects of bringing a medical device to market. The webinar explores topics ranging from market concept to post-market surveillance. Entering a medical device market involves more than engineering and regulatory compliance. Companies need to consider a variety of issues to successfully enter the medical device market.
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EU's MDR Effect on U.S. Exports
Casper Uldriks
60 Min
Product Id: 706316
Attend this webinar to learn about the new EU legal requirements for exporting medical devices to the EU. Learn how to prepare for this MDR requirement and include options for selling your device in the EU and the U.S.