As announced on Monday, October 17, 2016, by the United States Department of Justice (“DOJ”), the nation’s largest nursing home pharmacy, Omnicare Inc...
NDAs offer a standout amongst the most surefire approaches to protect trade secrets and other private data intended to be kept under wraps. Data norma...
Dr Simon, I have learned a lot from this course. It gave me knowledge about the Regulatory affairs, Quality Control and Quality Assurance. It has hel...
I would prefer to have a matrix organization because : Assets are utilized effectively and can move around between projects as required. You can chip...
Forming a project team is not an easy job. I would recommend to avoid following mistakes: Mistake #1: Not meeting with the whole team and setting goa...
I would like to work for matrix organization because matrix management is ideal for sharing talents and skills across departmental boundaries. One of ...
Responding to the various categories of risk There are four basic responses available to businesses depending on the category a given risk is placed:...
The best place to start is the traditional risk matrix. The underlying concept of ISO 14971:2007 is to estimate risk (the output of Risk Analysis in C...
The benefit-risk factors may be considered when device manufacturers evaluate appropriate responses to nonconforming product or regulatory compliance ...
The Design Review process helps with other challenges of an engineering team like: Inter-org communication. Often people don’t know what other folks a...
bunch of tips and how-to tricks from several experienced project managers. Start date, end date, duration: Track it all The best way to track an ongoi...
Design inputs are the foundation of medical device development. And without a strong foundation, bringing a new product to market can be problematic. ...
Five Tips for Passing Your FDA Audit with Confidence Passing a regulatory audit is the first priority of any manufacturer of medical devices. It can ...
Let’s dive deeper into why your design controls and risk management processes may be failing, and discuss what you can do about it. 1. Poorly Defined...
HI All, While reading through the FDA Design Control Guidance pdf, I came across this section, Can someone answer the following two Q's? The qual...