As announced on Monday, October 17, 2016, by the United States Department of Justice (“DOJ”), the nation’s largest nursing home pharmacy, Omnicare Inc. (a CVS Health company), has agreed to pay $28.125 million to resolve allegations that it solicited and received kickbacks from pharmaceutical manufacturer Abbott Laboratories in exchange for promo…[Read more]

NDAs offer a standout amongst the most surefire approaches to protect trade secrets and other private data intended to be kept under wraps. Data normally protected by NDAs may incorporate schematics for another item, customer data, deals and promoting plans, or a novel assembling process. Utilizing a nondisclosure assention implies your secrets…[Read more]

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 helped me put the knowledge at work and I have been using your presentations to learn more about implementing at my work place.
Not to forget the midterm paper proposal, it has made me aware of…[Read more]

I would prefer to have a matrix organization because :

Assets are utilized effectively and can move around between projects as required. You can chip away at loads of various things, once in a while in parallel—despite the fact that this point can be contended as a disservice too. Groups and people can be extremely responsive. In the event that a…[Read more]

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 goals upfront

“It’s important for the entire team to know roles and responsibilities and deliverables” right from the start, says Shami Ahuja, director of agile practice at technology consulting firm…[Read more]

I would like to work for matrix organization because matrix management is ideal for sharing talents and skills across departmental boundaries. One of the most common scenarios for matrix management is when a group of individuals from all different functions organizes under a project manager to create something new and unique.The ability to draw…[Read more]

Responding to the various categories of risk

There are four basic responses available to businesses depending on the category a given risk is placed:

Accept the risk as a cost of doing business, and decide to retain and budget for the risk ( self-insuring the risk)
Retain and budget for the cost of the risk, but take steps to reduce or avoid…[Read more]

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 Clause 4), evaluate the estimate against the acceptability criteria (in Clause 5), and determine the need for risk reduction (by applying Clause 6). In addition, after risk reduction, evaluate the…[Read more]

The benefit-risk factors may be considered when device manufacturers evaluate appropriate responses to nonconforming product or regulatory compliance issues, such as determining whether to limit the availability of a medical device (e.g., a voluntary recall or market withdrawal). FDA may consider the benefit-risk factors during, for example,…[Read more]

The Design Review process helps with other challenges of an engineering team like:
Inter-org communication. Often people don’t know what other folks are working on. With very large teams you might even have two different engineers working on the same problem and not realize it.
Surfacing legacy work. Due to having design reviews, engineers can k…[Read more]

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 ongoing project is using a Gantt chart. One important advantage of these charts is that the project plan remains on one page. All team members can easily track the progress of each task. The chart…[Read more]

Design inputs are the foundation of medical device development. And without a strong foundation, bringing a new product to market can be problematic.

Call them what you want (design inputs, design requirements, design and development inputs, etc.), getting your design inputs right is the most important thing you can do to make sure your device is…[Read more]

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 be an especially scary time for startup firms. All three medical device startups agree that if you take the time to organize your procedures, documents and data in clear, logical order, facing an…[Read more]

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 Product Development Processes — A medical device product development process needs to establish the major stages, deliverables, and milestones from project initiation through market launch. Des…[Read more]

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 quality system requirements for design output can be separated into two elements: Design output should be expressed in terms that allow adequate assessment of conformance to design input requirements and…[Read more]

Double blind procedure is a method of enhancing internal validity in an experiment. In double blind procedure, neither the researcher nor the subjects are made aware of which group is the experimental group and which the control group.

In double blind procedure, experimental group in a clinical study is the group which receives the actual drug or…[Read more]

I would like to Sponsor a clinical research. The reasons are as follows:

1. Selecting a clinical investigator
2. Monitoring the research
3. Ensuring clinical trial is being conducted as per the protocol and regulations
4. Making sure that investigators are informed about the possible outcomes of the research. (any adverse effects of drugs or…[Read more]