When preparing a budget for a clinical trial you need to perform an internal cost analysis by evaluating your study specifications and determining expected enrollment. You need to determine how long the study will take?, Are you able to find…   Read more»

Resources, budget,responsibilities and skills are main factors to determine how to manage a project in a small or a large company. Effective project management in a small business means reaching the project goals on time and within budget, despite having…   Read more»

Deciding on when to outsource clinical trial or insource depending on the project, capabilities and resources needed. I think insourcing is more expensive for an organization as a result of implementing new processes to start a different division of the…   Read more»

When equipment is moved to a new location, installation and operation should be re-qualified. By comparing data from the original installation and operation qualification (IQ and OQ) and the re-qualification, the manufacturer can determine whether there have been any changes…   Read more»

Example: Placebos Study Placebos are necessary for studies and clinical trials. When doing statistical analysis, you’ll have a controlled-group that’ll receive the drug or device in question for actual treatment and perhaps another group that’ll receive a type of “sugar…   Read more»

Actually AMDD very useful class. I learned a lot about the regulations and QSR in US and regulations in EU as well. Participation & Simulations great features for the class. This class took me to the real world problems in…   Read more»

For me I will choose CRA , as a CRA you will do studies may involve the development of a new medication or assessment of a new medical device.A CRA is one of the clinical science jobs that offers many…   Read more»

Motivation for a project manger is the key for success also Communication is another important key for a project manager. Project managers must communicate their visions clearly and project a project’s scope in a way that everyone can understand. They…   Read more»

For me I would like to work as an engineer and after 4-7 years I would like be a manager. Also, I think after getting more experience in the field I can start my own company. My goal to start…   Read more»

The definition of A Significant Risk (SR),is a device presents a potential for serious risk of health, safety and welfare of a subject, and are intended to be used as an implant and; purported to support or sustain human life;…   Read more»

clinical trials costs are largely driven by labor, much of these savings are from lower salaries to physicians, nurses, and trial coordinators. It is true that some regions of the globe are vastly more expensive than others to conduct clinical…   Read more»

During your work as a CRA, you will do studies may involve the development of a new medication or assessment of a new medical device.A CRA is one of the clinical science jobs that offers many opportunities to choose the…   Read more»

Think about it, if no GMP!, Making poor quality products does not save money. In the long run, it is more expensive finding mistakes after they have been made than preventing them in the first place. GMP is designed to…   Read more»

Hi thuytienlecao Internal audits could be done by the manufacturer itself or by hiring auditor.Both 21 CFR Part 820, the Quality System Regulation (QSR), and ISO 13485:2003 require internal quality audits. In QSR, the audits have two primary purposes: Assure…   Read more»

1)Who should do the communication on a project dependent on the organization set-up? Communication in any project is an essential tool for a PM, also regardless of your role on the project, you must learn how to communicate effectively (with…   Read more»

Adding to the discussion, systems approach to project management enables the project manager to constantly evaluate the needs of the customer and the end results that are needed to be achieved in terms of resources, budget and time. A successful…   Read more»

Different risk analysis methods like FMECA,FMEA includes (FMEA – PFMEA, Design FMEA – DFMEA), Root Cause Analysis (RCA),RCM (Reliability Centered Maintenance), and Risk and control self assessment (RCSA). For example: FMEA Failure mode and effects analysis. Benefits: – FMEA is…   Read more»

CAPA is required under 21CFR820.100 It requires manufacturers of medical devices to have clearly documented procedures for corrective and preventive action. CAPA is important to continuous improvement processes. CAPA can help to lower the cost of quality because of it…   Read more»

I thing the biggest advantage for internal audit, it gives you a chance to verify that your CAPA have been completed effectively and on time or not!. Also, the ability to identify non-compliance thing in the product and provide recommendations…   Read more»

GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances errors or problems from a medical device for example. GMP is also sometimes referred to as “cGMP”. the “c” stands for “current,” reminding manufacturers that…   Read more»