Salma Michor Thursday
21 June
, 2018
, 2018
10:00 AM PDT | 01:00 PM EDT
duration 60 Minutes
Salma Michor
¤150.00
The New EU Medical Device Regulation
Regulation proposals of the European Commission

Louis Angelucci Thursday
21 June
, 2018
, 2018
10:00 AM PDT | 01:00 PM EDT
duration 60 Minutes
Louis Angelucci
¤150.00
2011 FDA Guideline on Process Validation
The FDA in 2011 instituted its latest interpretation. Many have not chosen to take it seriously or change their business model. The paradigm has shifted and this presentation will articulate what has changed and how we need to react. Validation as derived from industry practice has a new spin. This presentation will take you through that development and demonstrate how some in the industry have reacted to the new expectations.

Angela Bazigos Thursday
21 June
, 2018
, 2018
09:00 AM PDT | 12:00 PM EDT
duration 3 Hours
Angela Bazigos
¤290.00
3-Hour Virtual Seminar On Medical Device Recalls: How to Properly, Compliantly, and Promptly Deal with a Recall
Medical Device Recalls are an effective method of removing or correcting consumer devices that are in violation of laws administered by the Food and Drug Administration. Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from devices that present a risk of injury or gross deception or are otherwise defective.

Eyal Lerner Friday
22 June
, 2018
, 2018
10:00 AM PDT | 01:00 PM EDT
duration 90 Minutes
Eyal Lerner
¤150.00
The New ISO 13485: 2016 and Comparison with 21CFR820 - how to Comply with Both in the same Organization
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).

Lena Cordie Friday
22 June
, 2018
, 2018
10:00 AM PDT | 01:00 PM EDT
duration 90 Minutes
Lena Cordie
¤150.00
Software Verification & Validation
Software problems are now the third-leading cause for recalls of medical devices. Most recalls are because of incorrect verification and validation for safety. Most of the knowledge on how to do a comprehensive V&V is not widely understood.

Charles H. Paul Monday
25 June
, 2018
, 2018
10:00 AM PDT | 01:00 PM EDT
duration 60 Minutes
Charles H. Paul
¤150.00
Project Management for Non-Project Managers
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

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Angela Bazigos
Recorded
View Anytime
¤390.00
Angela Bazigos
Export Certificate for Medical Devices - Edge Out Your Competition!
In today's global environment, sustaining competitive advantage within the medical device industry involves a global product strategy that recognizes the issues involved in managing regulations across different countries. To this end, certain countries require an Export Certificate that the manufacturer and its devices are indeed in compliance with FDA regulations.

Miles Hutchinson
Recorded
View Anytime
¤149.00
Miles Hutchinson
How to Design and Implement Outstanding KPI Performance Dash
Grab a cup of coffee and join us to learn how to improve your KPI focus, and juice up virtually every facet of your organization's operations from marketing, to finance, to HR, to customer service and sales. Ensure your Performance Dashboards are crisp, attention grabbing and clearly identify significant performance trends. Know whether your business is meeting or exceeding its goals with your early warning system of leading and trailing performance indicators.

Miles Hutchinson
Recorded
View Anytime
¤149.00
Miles Hutchinson
Introduction to Sales and Use Taxation
Join us and you can begin to develop a solid plan to move your company toward sales and use tax compliance. Experienced CPA and businessman, Miles Hutchinson, will review the basics of sales and use taxation with you and answer your questions. He will discuss legal developments in the area of taxation of internet sales. You will receive practical guidance to avoid penalties due to the ever increasing instances of audits by state taxing authorities.

Miles Hutchinson
Recorded
View Anytime
¤149.00
Miles Hutchinson
Hot Issues in Determining Multi-State Sales Tax Nexus
Gain valuable insight into the complex issues of interstate sales and the obligations of out-of-state (foreign) sellers to collect the destination state’s taxes. Get up-to-date information about the retailing giants and their fights with the various states. Take a ring-side seat with an expert who will share the anticipated outcomes.

Miles Hutchinson
Recorded
View Anytime
¤149.00
Miles Hutchinson
Complying with FATCA - the Foreign Accounts Tax Compliance Act
Miles Hutchinson, experienced CPA and financial analyst, will discuss the basic principles of FATCA, the affected businesses and individuals, the new and revised forms to effect compliance and provide you with simplifying charts and tables to help you determine your steps to full compliance. He will provide practical instructions and guidance for applying FATCA and will identify the key issues that will help you avoid potential penalties for noncompliance.

Rodriguez Gonzalez
Recorded
View Anytime
¤149.00
Rodriguez Gonzalez
Compliance and Continual Improvement, Tools of the Trade
Meeting regulatory specifications is the minimum that a business needs to get done to operate in a market without falling in the risk of non-compliance. This type of requirements are analog to those required by the customers, and the Continual Improvement tools used for quality control are interchangeable. The idea of this webinar is to provide a visualization of regulatory requirements from a Continual Improvement angle. Ideas and examples of how Continual Improvement tools can be utilized to facilitate the management of regulatory issues will be provided.

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