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Selecting the Most Appropriate Predicate Device(S) for your 510(k) Application
Cheryl Wagoner
60 Min
Product Id: 703438
This webinar will provide tips and techniques on how to research and identify appropriate predicate devices for a 510(k) application.
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Equipment Requalification: What and When it is Really Required?
Jennifer Medlar
60 Min
Product Id: 703450
This webinar will explain how to generate a practical and compliant methodology to handle equipment requalification. Attendees will learn about common pitfalls to avoid when requalifying equipment.
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Regulatory Records Primer: Decoding the Requirements for Medical Device and Pharmaceutical Manufacturers
Les Schnoll
90 Min
Product Id: 703433
This webinar will explain FDA regulatory records requirements for medical devices and finished pharmaceuticals. It will cover statutory requirement, required content, format, purpose, retention, and structure for regulatory records for both medical devices and pharmaceuticals.
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Quality Systems Approach for Validation and Maintenance of a Global ERP System
James Carron
90 Min
Product Id: 703424
This webinar will explain how to implement an Enterprise Resource Planning (ERP) system by integrating a company’s existing quality system. It will cover selection, analysis, initiation, design, validation and test phases, including change control.
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LDT including CDx; CLIA versus FDA's Authority
Abdel Halim
60 Min
Product Id: 703399
This webinar will explain the regulatory path of an in vitro diagnostic (IVD) and Laboratory Developed Test (LDT). It will discuss the CLIA regulations for Laboratory Developed Tests (LDTs), including companion diagnostics (CDx) and how these differ from the FDA’s authority.
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Medical Device Excise Tax
Daniel O Leary
90 Min
Product Id: 703114
This webinar explains the excise tax on medical device manufactures that went into effect on January 1, 2013, including the devices it covers and the effective selling price for tax purposes.
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Overview of the Medical Device Risk Management Standard-ISO 14971
Edwin L Bills
90 Min
Product Id: 700524
This medical device risk management webinar will provide attendees an overview of ISO 14971requirements and practical tips for implementing an effective system for managing risk. It will also discuss differences between the world-wide international standard ISO 14971:2007 and the Europe-only version risk management standard EN ISO 14971:2012.
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Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements
Jeff Kasoff
60 Min
Product Id: 700254
This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control.
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FDA Regulatory Actions: It's Not Just about Warning Letters
Fredric Richman
60 Min
Product Id: 703344
This training will outline the possible consequences for failing to promptly and adequately correct significant violations related to cGMPs, new drugs or devices, labeling or other regulatory issues resulting in advisory, administrative and judicial actions.
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FDA Premarket Review of New and Modified Tobacco Products
Azim Chowdhury
60 Min
Product Id: 703127
This training on FDA regulatory requirements for tobacco products will focus on the premarket review of new and modified tobacco products. It will also discuss the impact of FDA deeming regulation for of e- cigarettes and novel tobacco products on premarket authorization requirements.
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How to file a 510(k) when your device is (or contains) software
Cheryl Wagoner
75 Min
Product Id: 703366
The Webinar will discuss the structure and level of detail required in filing a 510(k) when a medical device is software or contains software.
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Understanding ISO 13485 vs. ISO 9001 for Successful QMS in Medical Device Industries
John Chapman
60 Min
Product Id: 701003
This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. ISO 13485:2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485:2003 will find themselves very closely compliant with FDA’s Quality System Requirements under 21CFR 820. This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements.
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Mobile Medical Applications: Software Regulatory Requirements
Tim Stein
90 Min
Product Id: 702812
This mobile medical apps training will outline the regulatory requirements for medical device software development processes, and the requirements for submissions.
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Supplier Quality Management: Implement it Now or Pay for it Later
Les Schnoll
90 Min
Product Id: 703357
This webinar will discuss FDA's requirements for medical device supplier management and the controls you need to have in place to ensure compliance with quality. It will cover how to structure a supplier quality agreement and the tools and methods you need for evaluating and assessing suppliers.
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Are you prepared for a regulatory audit from FDA or any other regulatory body?
Philip Russ
90 Min
Product Id: 703355
This FDA audit training provides an overview of the audit readiness process from internal evaluation of your quality systems to the logistics of the audit itself; with key emphasis placed on equipping you and your team with the skills needed to present expert testimony during interviews with regulators.
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Major Changes to the EU Clinical Trials Regulation: What is Required for Compliance
Laura Brown
60 Min
Product Id: 703336
This webinar will help Sponsors, CROs and study sites running clinical trials in the EU and internationally; understand the important, updated compliance requirements concerning the new EU Clinical Trials Regulation due to be enacted in 2016 and which will replace the 2001 Clinical Trials Directive (CTD) (2001/20/EC).
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Regulatory Documentation for Clinical Trials
Adam Ruskin
60 Min
Product Id: 703329
This clinical research compliance training will explain in detail the list of required regulatory documentation for clinical trials for industries such as pharmaceutical, biotechnology, medical devices and diagnostics. It will also review many of the documents in terms of required content and structure.
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3-hr Virtual Seminar: FDA's Establishment Registration and Product Listing Requirements, User Fees, Fee Waivers and Market Exclusivity
Karl M. Nobert
3 hrs
Product Id: 703269
This 3-hour training will review and compare FDA’s Establishment Registration and Product Listing Requirements; and available User Fees, Fee Waivers and Marketing Exclusivity for Drugs, Biologics, Medical Devices, Food, Tobacco and Animal Health Products.
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3-hr Virtual Seminar: Aligning Medical Device Software Development with EU Requirements for a CE Mark (IEC 62304)
Tim Stein
3 hrs
Product Id: 702008
This 3 hour virtual seminar will help you create an integrated medical device software development process that will meet IEC 62304 and ISO 13485 design control requirements, and generate the documentation needed for software as part of a FDA submission.
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Understanding the FDA ''Refuse to Accept'' guidance to avoid administrative rejection of your 510(k)
Cheryl Wagoner
60 Min
Product Id: 703235
The webinar will familiarize participants with the FDA's Refuse to Accept Policy for medical device 510(k)’s and help you ensure that your 510(k) application is not rejected for lack of administrative completeness.