hmp42 | Medical Device Courses

hmp42 replied to the topic "Written Agreement v/s Verbal Agreement" – 5 years, 10 months ago

Hi all Nice discussion so far.Written agreements are important to avoid risk of genuine mistakes.It is legal way of doing things. Written agreement formally prevents one party from making the same verbal agreement with multiple other parties, protecting the business… Read more»
hmp42 replied to the topic "Discussion Topic: Course conclusion and impressions" – 5 years, 10 months ago

I would like to share my personal experience.Last semester,I took System Management for Medical Device-online course from Dr.Simon.While as a graduate student when i went to give my first in person interview for a pharma company,i would have not blessed… Read more»
hmp42 replied to the topic "Forming a Project Team" – 5 years, 10 months ago

Good discussion so far.I would like to shift a focus little bit.What if you do not have option to pick? Which is the situation in most of the time.In such cases one should have to look up for strategies to… Read more»
hmp42 replied to the topic "Project Management Preferences" – 5 years, 10 months ago

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,… Read more»
hmp42 replied to the topic "Risk management methods" – 5 years, 10 months ago

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… Read more»
hmp42 replied to the topic "Risk Management Mistakes" – 5 years, 10 months ago

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… Read more»
hmp42 replied to the topic "Sample Size Based on Risk Analysis" – 5 years, 10 months ago

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… Read more»
hmp42 replied to the topic "When is validation is not required?" – 5 years, 10 months ago

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… Read more»
hmp42 replied to the topic "Minutes for meetings" – 5 years, 10 months ago

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… Read more»
hmp42 replied to the topic "Design Controls for Legacy Combination Products" – 5 years, 10 months ago

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),… Read more»
hmp42 replied to the topic "Design Verification & Validation" – 5 years, 10 months ago

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… Read more»
hmp42 replied to the topic "Important Part of DDP" – 5 years, 10 months ago

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… Read more»
hmp42 posted a new topic "Anti-kickback & Stark Cases" – 5 years, 10 months ago

There are majorly 5 types of federal fraunds. (1) False Claims Act(FCA) (2) Anti-kickback Status(AKS) (3) Referral/Stark Law (4) The Exclusion Authorities (5) Civil Monetary Penalties Law(CMPL) As i was going through some articles about top most federal frauds that… Read more»
hmp42 posted a new topic "Organizational Behavior Management" – 5 years, 10 months ago

As Dr.Simon have stated organizational behavior is very important to improve performance. Recently i came across one interesting paper on organizational behavior management in healthcare. Organizational behavior management (OBM) focuses on what people do, analyzes , and then applies strategy… Read more»
hmp42 posted a new topic "Factors to Consider While making Gantt Chart" – 5 years, 10 months ago

As we all know before setting up Gantt Chart we should have detailed project plan. Some important factors while preparing Gantt Chart are, • Defining clear project settings. • Start date and end date. • Each task name and duration…. Read more»
hmp42 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics 8 years, 4 months ago

Hi all

Nice discussion so far.Written agreements are important to avoid risk of genuine mistakes.It is legal way of doing things. Written agreement formally prevents one party from making the same verbal agreement with multiple other parties, protecting the business arrangement. Working on project involves so many plans to work out at the same…[Read more]
hmp42 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics 8 years, 4 months ago

Hi all

Nice discussion do far.Written agreements are important to avoid risk of genuine mistakes.It is legal way of doing things. Written agreement formally prevents one party from making the same verbal agreement with multiple other parties, protecting the business arrangement. Working on project involves so many plans to work out at the same…[Read more]
hmp42 started the topic Anti-kickback & Stark Cases in the forum Consultants and Legal Basics 8 years, 4 months ago

There are majorly 5 types of federal fraunds.
(1) False Claims Act(FCA)
(2) Anti-kickback Status(AKS)
(3) Referral/Stark Law
(4) The Exclusion Authorities
(5) Civil Monetary Penalties Law(CMPL)

As i was going through some articles about top most federal frauds that are applicable to physicians,i got one interesting articles regrading cases which…[Read more]
hmp42 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics 8 years, 4 months ago

I would like to share my personal experience.Last semester,I took System Management for Medical Device-online course from Dr.Simon.While as a graduate student when i went to give my first in person interview for a pharma company,i would have not blessed myself so much for taking this course.For half an hour interview,i would have been speechless…[Read more]
hmp42 replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies 8 years, 4 months ago

Good discussion so far.I would like to shift a focus little bit.What if you do not have option to pick? Which is the situation in most of the time.In such cases one should have to look up for strategies to manage conflict and disagreements. As PMBOK suggests some of the ways to manage conflicts are.

(1) Avoidance
(2) Compromise
(3) Delegation
(4)…[Read more]
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