Eleonora Babayants Tuesday
19 June
, 2018
, 2018
10:00 AM PDT | 01:00 PM EDT
duration 90 Minutes
Eleonora Babayants
¤150.00
Corrective and Preventive Action (CAPA) per FDA Requirements
CAPA - Corrective and Preventive Action plan. CAPA is a concept within Good Manufacturing Practice (GMP). It is required for FDA compliance in case of specification situations or other deviations. CAPA is part of the overall quality management system (QMS).

Casper Uldriks Tuesday
19 June
, 2018
, 2018
10:00 AM PDT | 01:00 PM EDT
duration 60 Minutes
Casper Uldriks
¤150.00
FDA's New Import Program for 2018
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry.

Angela Bazigos Wednesday
20 June
, 2018
, 2018
10:00 AM PDT | 01:00 PM EDT
duration 90 Minutes
Angela Bazigos
¤150.00
What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections
This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.After this event, you will be fully prepared for cGMP regulatory inspections in those countries.

John E Lincoln Wednesday
20 June
, 2018
, 2018
08:00 AM PDT | 11:00 AM EDT
duration 3 Hours
John E Lincoln
¤290.00
3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.

John N. Zorich Wednesday
20 June
, 2018
, 2018
10:00 AM PDT | 01:00 PM EDT
duration 90 Minutes
John N. Zorich
¤150.00
Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.

Christina Bernstein Wednesday
20 June
, 2018
, 2018
10:00 AM PDT | 01:00 PM EDT
duration 60 Minutes
Christina Bernstein
¤150.00
Medical Devices: Hazard Identification and Risk Assignment Using Public Data Sources
There is no universal standard for assigning risk to a medical device, and competing manufacturers of devices may quantify risk differently for similar identified hazards. One manufacturer may identify a hazard as a high enough risk to warrant triggering an alarm, and their competitor may decide that same hazard is not such a high risk and just note it as a "feature" for the label. We will together construct a simple example of a risk table using known standards, guidelines, regulations, and public data.

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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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