Angela Bazigos Monday
20 August
, 2018
, 2018
10:00 AM PDT | 01:00 PM EDT
duration 90 Minutes
Angela Bazigos
¤150.00
Project Management for Computer Systems Validation and 21 CFR 11 - Annex 11
Project Management is defined as the planning and organization of an organization's resources in order to move a specific task, event or duty toward completion. However, Validation of Computerized Systems has a very specific set of tasks that are often mismanaged, resulting in missed deadlines, increased costs, and regulatory risk, and missed times to market for a company's product.

Marina Malikova Monday
20 August
, 2018
, 2018
10:00 AM PDT | 01:00 PM EDT
duration 90 Minutes
Marina Malikova
¤150.00
FDA Regulation of Human Cells,Tissues and Cellular and Tissue-Based Products (HCT-Ps)
This course offers extensive examination of the FDA's regulations of biological products such as HCT/Ps from pre-clinical testing to post-marketing regulatory requirements. Specific ethical and regulatory considerations will be discussed for various HCT/Ps. For example, in 2006, the U.S. FDA implemented regulations governing the use of human cells, tissues, and cellular and tissue-based products in humans including bone, ligament, skin, dura mater, stem cells, cartilage cells, and various other cellular and tissue-based products.

Casper Uldriks Tuesday
21 August
, 2018
, 2018
09:00 AM PDT | 12:00 PM EDT
duration 3 hours
Casper Uldriks
¤290.00
3-Hour Virtual Seminar: FDA Imports Require Precision in 2018
Importing FDA regulated products requires careful planning before you even start. Registration, product compliance, record and data submission must be exactly correct, or else, FDA's entry requirements with detain your product. Some mistakes are common, others reflect a lack of understanding of how FDA and Customs and Border Protection (CBP) operate a joint program.

Angela Bazigos Tuesday
21 August
, 2018
, 2018
09:00 AM PDT | 12:00 PM EDT
duration 3 Hours
Angela Bazigos
¤290.00
3-Hour Virtual Seminar on How the FDA are Trained for Medical Device Inspections
This webinar will examine the training that FDA inspectors receive on five regulations for inspecting medical device firms.It will present the specific guidance FDA inspectors receive for each of the regulations.

Susanne Manz Wednesday
22 August
, 2018
, 2018
10:00 AM PDT | 01:00 PM EDT
duration 3 Hours
Susanne Manz
¤290.00
3-Hour Virtual Seminar on CAPA for Medical Devices
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. This 3-hour webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. Learn how to avoid common problems and establish an efficient and effective CAPA process leading to improved quality and compliance for your company.

Ron Rael Thursday
23 August
, 2018
, 2018
10:00 AM PDT | 01:00 PM EDT
duration 90 Minutes
Ron Rael
¤150.00
Strategic Management of Corporate Governance: Setting the Right Tone at the Top about Risk, Part 1
What is a risky decision? How do you size up a risk's impact? How do you hold reckless risk-takers accountable?

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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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