Very interesting topic Lamiaa. I believe it would be more challenging to work in matrix organization for a project manager.In matrix organization,the product manager would find himself working across functional lines to try to coordinate production schedules, inventories, cash flow, and distribution patterns. Because he has approved all future…[Read more]

Good discussion so far! I would like to add more to HACCP-Hazard Analysis Critical Control Point. HACCP process could be divided as following.

• Conduct a Hazard Analysis.
• Identify Critical Control Points.
• Establish the critical limits of the control.
• Monitor your CCPs.
• Corrective Actions.
• Establish record keeping procedures.…[Read more]

Agree with all of you! As I was also going through Harvard Business review, they have listed top 6 mistakes made by executives for risk management. They are,
• Risk is not only determined by predicting extreme events.
• Take recent advice but don’t Only refer to past.
• Relying on historical data.
• Overlooking Concealed risks.
• Not managing in…[Read more]

Selection of sample size for clinical study is always critical choice. Few samples do not represent size of target population. On the other hand, more samples than required put more individuals to the risk of the intervention. Additionally, it is wastage of time and resources.
Optimum number of participants required to be able to arrive at…[Read more]

Selection of sample size for clinical study is always critical choice. Few samples do not represent size of target population. On the other hand, more samples than required put more individuals to the risk of the intervention. Additionally, it is wastage of time and resources.
The calculation of an adequate sample size so it is crucial in any…[Read more]

Fady

Validation is powerful tool to achieve highly effective product. As we all have learned, Verification is to look any flaws in the products, whereas Validation is necessary for judging it through end user’s perspective. In my opinion, even if validation is not performed due to reasons listed above, it is always good practice to conduct h…[Read more]

Hi Roberto
You brought interesting topic and good discussion so far. As we are going to work towards our final project I would like to point out what to include when writing down meeting minutes.

• Date, Time and Place of Meeting.
• Clear goal of meeting.
• Attendees list.
• Actions taken.
• Decisions made.
• Agenda for next meeting, if somethin…[Read more]

Hi Roberto
You brought interesting topic and good discussion so far. As we are going to work towards our final project I would like to point out what to include when writing down meeting minutes.

• Date, Time and Place of Meeting.
• Clear goal of meeting.
• Attendees list.
• Actions taken.
• Decisions made.
• Agenda for next meeting, if somethin…[Read more]

Good Discussion so far. A legacy device is one that incorporated a drug before combination product regulations arrived. Many medical device manufacturers have mistakenly assumed that since legacy products were initially reviewed by Centers for Devices and Radiological Health (CDRH), but for combination products that is not true. Developing…[Read more]

Good Discussion so far. A legacy device is one that incorporated a drug before combination product regulations arrived. Many medical device manufacturers have mistakenly assumed that since legacy products were initially reviewed by Centers for Devices and Radiological Health (CDRH), but for combination products that is not true. Developing…[Read more]

As per my understanding, Validation is concerned with making sure that the system meets the customer’s actual needs, while verification is concerned with whether the system is well-engineered, error-free, and so on. Verification will help to determine whether the software is of high quality, but it will not ensure that the system is useful at c…[Read more]

As per my understanding, Validation is concerned with making sure that the system meets the customer’s actual needs, while verification is concerned with whether the system is well-engineered, error-free, and so on. Verification will help to determine whether the software is of high quality, but it will not ensure that the system is useful at c…[Read more]

As per my understanding, Validation is concerned with making sure that the system meets the customer’s actual needs, while verification is concerned with whether the system is well-engineered, error-free, and so on. Verification will help to determine whether the software is of high quality, but it will not ensure that the system is useful at c…[Read more]

I agree with most of you here. The company needs to manage different groups involved in design development, so for such part indeed communication management plan is very essential to mention responsibilities. It is basically a good mixture of activities listed. Some of the important aspects about design development plan are,
• Identify all s…[Read more]

I agree with most of you here. The company needs to manage different groups involved in design development, so for such part indeed communication management plan is very essential to mention responsibilities. It is basically a good mixture of activities listed. Some of the important aspects about design development plan are,
• Identify all s…[Read more]