All Blog Posts Tagged 'FDA' (145)

For regulatory professionals who work in the field of healthcare, compliance with the regulatory requirements is a must. We are all aware of it. But if the cost of healthcare compliance courses is causing you to put off your trainings, GlobalCompliancePanel has the answer: Its special deal in 2017 for healthcare compliance course attendees makes trainings in healthcare compliance available for $10. Yes, you’ve read that right. All it takes is $10 to enroll for a course in healthcare…

Did you know that an online life sciences course offer 2017 by GlobalCompliancePanel @ 10$ is on? Want me repeat this to confirm its veracity? Yes. It is true, and it is real. An online life sciences course offer 2017 by GlobalCompliancePanel @ 10$ is underway! But is it possible for anyone to offer online life sciences…

Risk Management Webinars Online - Just Pay @ $10. This is not the catchphrase for an ad that is showing up the wrong product by mistake. You could be forgiven for thinking so, for it is natural and predictable to mistake these catchy words for being ads for some daily use items. But then, these words are not the slogans for products or services that are meant for daily use.…

The FDA’s regulations on cleanroom environmental monitoring (EM) are based on the assumption that any person who enters a cleanroom is likely and almost certain to have brought contaminants in one or another form with him. The FDA’s regulations on cleanroom environmental monitoring are built on the thinking that microorganisms can assail even the cleanest of systems, which is why its regulations on cleanroom…

Quality controls in laboratories are a major area for which the FDA issues 483’s. A laboratory is the venue for many activities, all of them of varying importance to the product. When controls in laboratories are not up to the standard, such a laboratory could produce products that do not meet quality and processes expectations, and hence invite 483’s.

Issues with drug quality, drug integrity and data integrity, as well as data fabrication and human errors…

In September 2014, the FDA deployed a new risk-based screening tool for imports called the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT). The main aim of PREDICT was bringing about improvement in screening and targeting of adulterated or misbranded goods or those that flout any of the FDA’s rules. The FDA seeks to bring this about by doing away with its legacy electronic system, OASIS’ admissibility screening function.

PREDICT is an important tool…

Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971.

You’ll learn techniques that can help you identify hazards and potential harms. You’ll learn how to mitigate risk and effectively monitor risk to ensure your customers receive safe and effective products. A rigorous…

Overview of this session Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement them.

You’ll learn techniques that can help you identify hazards and potential harms. You’ll learn how to mitigate risk and effectively monitor risk to ensure your customers receive safe and effective…

GlobalCompliancePanel’s seminars are a wonderful opportunity for professionals in the regulatory compliance areas to understand the latest happenings and updates in the…

Below is the event description content:

Compliance4All webinars are just what professionals in the regulatory

compliance areas need for scaling up in their careers. With a collection of

the most erudite experts on regulatory compliance being available at a click

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Compliance4All’s experts help you unravel all the knowledge you need…

A n internal audit program of an organization’s Quality Management Systems is a core requirement from both the ISO and the FDA. At its barest, an internal audit system can be understood to be an assessment or inspection of an organization’s Quality System. Audits are a very beneficial and positive tool for continually ensuring that an organization’s internal management…