GlobalCompliancePanel announces Seasonal offers for Professionals with Flat 50% OFF on all Seminars

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Do celebrations need a cause and a reason? Yes, and GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, is having a solid cause and reason for doing so. It is celebrating the many years of its relationship with its customers spread all over the world by offering its trainings at a massive 50% discount!

Yes, that is right. GlobalCompliancePanel’s seminars will be available for a huge 50% discount till April 30. Regulatory professionals who want to augment their knowledge of regulatory compliance can now do so by paying just half the price of these trainings from GlobalCompliancePanel. All that is needed to do walk away with a rare offer such as this is to visit https://www.globalcompliancepanel.com/seminar?wordpress_SEO and use MGCP50 Promo Code.

This offer is valid till April 30, 2017. Regulatory professionals who want to take any of GlobalCompliancePanel’s trainings can book their trainings for an area of their interest by this date. From April 1 onwards, this offer will cease, meaning that the original price will apply from then.

So, why is GlobalCompliancePanel offering this discount? It is for a simple, but profound reason: It wants to thank its huge customer base for the support they have been extending to this company over the many years for which it has been in business. During the course of the 10 years for which GlobalCompliancePanel has been in business, it has trained thousands of regulatory compliance professionals from around the world.

These professionals, belonging to such varied geographies as the US and Japan and India and Canada, have been able to meet their regulatory compliance challenges on account of these trainings. These trainings are relevant, focused and valuable, and are from some of the best known regulatory compliance Experts found anywhere on this planet.

It is these trainings that have been hoping these professionals in the regulatory compliance arena gain more insights into regulations from the FDA, the EMA and other such bodies around the world. These trainings have been consistently helping them to meet these challenges, as they give them a better and sharper understanding of the implementing these requirements.

These regulatory requirements can pose hurdles to the most experienced and brightest of regulatory compliance professionals in the medical devices, pharmaceutical, life sciences and food and biologicals areas, but not to those who undertake professional trainings from GlobalCompliancePanel. GlobalCompliancePanel’s panel of experts is here to help them overcome these challenges and hurdles.

This trend has been being witnessed from the time GlobalCompliancePanel entered the line of professional trainings. Any wonder then, that no fewer than 50,000 professionals have benefited from these trainings? What could be a better way of thanking such a huge base of customers than with this offer? GlobalCompliancePanel believes that a celebration should also be useful, and this is that this offer is!

Hurry up and enroll today. Happy learning!

 

 

510K is a Pre-Market Notification (PMN) for new or modified medical devices

Description: 510K certifies that the medical device is at least as safe and effective as a predicate device

Brief Introduction to 510k

 

What is 510K?

510K is called as Pre-Market Notification (PMN) and is applicable for new or modified medical devices for marketability in the United States of America. 510K clearance has to be obtained from FDA. This clearance refers to the Section 510K of the 1976 Federal Food, Drug and Cosmetic Act which deals with Class II category medical devices.

A 510K clearance means that the medical device is at least as safe and effective as a predicate device that is legally marketed and not subject to premarket approval.

Classification of Medical Devices

The medical devices are categorized into three Classes, by the Federal Food, Drug and Cosmetic Act, based on the risk factors involved:

  1. Class I-these are low risk devices like bed pans, crutches or elastic bandages
  2. Class II-these pose moderate level of risk like sutures, intravenous administration sets, blood pressure cuffs and many other devices
  3. Class III- these are high risk devices like implantable pacemakers, breast implants and others.

Note that the Class I does not require FDA clearance, Class II requires 510K clearance (PMN) and Class III requires Premarket Approval (PMA).

Circumstances that Require 510 K Clearances

A new medical device or changes in the intended use of an existing device, changes in basic operation, changes in sterilization method, or changes in performance specification, changes in blood contacting materials or any contraindications are the circumstances that call for a fresh 510K clearance.

Contents of a 510KSubmission

A submission for 510K clearance should contain documents pertaining to the

  1. Description of the device
  2. Data pertaining to preclinical, clinical or non-clinical performance
  3. The label on the device
  4. Device usage instructions
  5. Product comparison with the predicate
  6. Documentation pertaining to any software or a firmware is used in the device
  7. Any other applicable documentation or specific requirements of the medical device.

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884Image