The FDA has recently announced the launch of the Oncology Center of Excellence (OCE). The FDA has appointed Dr. Richard Pazdur as its director. The idea behind the center is to make oncology the first disease area to have a coordinated clinical review of drugs, biologics and devices across the agency’s three medical product centers. [...]
Posted on 16. Feb, 2017 by UL Compliance to Performance.
In this current environment of continuous improvement, the medical device industry has been playing catch-up by tirelessly revising processes and documentation to meet quality standards and keep up with technological advancements. Governments and regulatory agencies are no exception. Just as FDA updates are published annually for the Code of Federal Regulations, international agencies are focused [...]
With the advent of social media and ubiquitous technology tools, there has been a large push in some circles for an increase in informal learning. Learning that occurs between co-workers and colleagues sharing institutional knowledge and procedures seems like a great idea to strengthen bonds within the company and to help reinforce critical knowledge within [...]
What happens when an employee attends an outside training event – and wants to apply it to an assigned training item? For ComplianceWire® subscribers, one option is to have the learner provide a certificate, and then build an “equivalency” for the assigned training item. This moves the item from the To-Do List to the History [...]
In one of his last acts as President of the United States, Barack Obama signed the bill which allocated $6.3 billion to fund various efforts to eradicate cancer. The efforts include money to fund drug treatment and research as well as money for seven years of funding for other health-related initiatives. The additional funding includes [...]
Quality or lack of quality in a manufacturing process can lead to warning letters and serious issues with the FDA. Here is a list of several infractions found in warning letters from 2016 related to manufacturing quality. The write-ups and issues in the warning letters should serve as a reminder to organizations that did not [...]
Posted on 19. Jan, 2017 by UL Compliance to Performance.
US FDA addressed data integrity in clinical trials earlier this year when the agency released Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations. The guidance emphasizes the need for both system and process controls to support data quality and the appropriateness and completeness of patient informed consent to enable such interoperability. [...]
Posted on 12. Jan, 2017 by UL Compliance to Performance.
As Life Sciences companies expand globally, opening new facilities or adding new suppliers, they face three main document and training management risks: compliance and regulatory issues, lost knowledge and change management. Regulatory Scrutiny: Global regulatory agencies, including US FDA, have made procedural control a top enforcement issue. In fact, the most cited US FDA observation [...]
The Mutual Reliance Initiative or MRI as it’s known is an attempt to leverage resources so that investigators and inspectors from FDA and trusted partners, such as those in the European Union, work together. The goal is for each organization to rely on each other’s inspections, avoid duplicating inspections, and conduct more inspections in areas [...]