Most medical device companies face the corrective and preventive action (CAPA) process year after year. In order to comply with FDA requirements, companies should have documented the procedures of CAPA and ensure that those procedures are actually followed. CAPA is a common compliance problem companies encounter throughout their design and development cycle despite the regulations being relatively clear. CAPA Problems: 5 of the Most Common CAPA planning is important for your company's overall success, not just from the regulatory perspective. Let us look at some of the common CAPA problems. Cross-Functionality is Lacking Any organization's Quality team typically owns ... Read More

Different people define quality differently. Some consider meeting compliance needs to be quality. Some define quality as improving the quality of life for a patient using their device. Some define quality as improving the quality of life for a patient using their device. Developing a quality culture within your company is different from meeting the quality regulatory norms and standards, and this post will explain all you are required to know. It is important for medical device companies to strive to refine and improve their culture. Let's first look at what the term "quality culture" really means. Quality Culture: What ... Read More

In recent years, many companies have accelerated their digital transformation to remain competitive and even survive the Covid-19 pandemic across a wide range of industries. B2C and B2B sectors have both experienced changes in consumer behaviors, knowledge consumption, and processes as the world and its consumers become more digital. As per Statista, digital transformation expenditure will reach 1.8 trillion dollars in 2022 and 2.8 trillion dollars by 2025, showing how much companies are investing to remain competitive. Is it possible for your business to transform to be where your customers are? How are different industries ensuring their long-term survival in ... Read More

A project manager incontrovertibly wears multiple hats during the course of a project and one of the most demanding roles out of the many would arguably be that of a liaison. Having to be the mediator between multiple people is not an easy task especially when each of the individuals involved holds variable interests within the same project. These individuals having an interest in the project are stakeholders and may or may not influence the performance of the project based on the role they play within the project. Therefore it is highly important that a project manager undertake stakeholder analysis ... Read More

The CCBA® certification from the International Institute of Business Analysis™ (IIBA®) is globally recognized as a standard of achievement in the field of business analysis. As the demand for qualified business analysts grows, so does the competition to pass the CCBA® exam and earn this coveted credential. The CCBA® (Certification of Competency in Business Analysis) certification is a globally recognized credential that validates an individual’s ability to perform business analysis tasks. The certification is administered by the International Institute of Business Analysis (IIBA). To become CCBA® certified, individuals must meet certain experience and education requirements, and then pass the CBAP® ... Read More

Regardless of whether it is over a dinner plan or a million-dollar business deal, individuals are often required to negotiate through plans and decisions. This is in order to reach a satisfactory conclusion to the discussion undertaken with others who differ in opinion. Through negotiation, a mutual understanding or agreement can be achieved where the parties involved have negotiation is most effective when all involved individuals get the opportunity to feel that they have gained something from the negotiation and that a compromise has been achieved. The outcome of a negotiation is unpredictable and could result in either a win-win ... Read More

With the 18-month-long delivery cycles becoming a wild goose chase for clients and organizations, agile methodologies are now the safest bet with quarterly releases and two-week delivery cycles. Agile way of working appeals to the customers and project members alike as the product gets to market faster. However, when companies go agile, project managers bear the brunt of updating the project plans to the client every week. This necessitates frequent meetings within the team to discuss project updates and progress. Through this article, let’s get into the crux of a project status meeting and how it be a ... Read More

India’s sophisticated Vande Bharat express project led by Mr. Sudhanshu Mani was completed in less than 18 months with just Rs. 97 crores, where the external agency has quoted Rs. 250 crores. He owes the success of this project to his team and the planning behind it. Irrespective of the project type, planning plays a crucial role in reducing risks, identifying desired goals, and ultimately delivering the agreed prototype. According to PMI, most organizations waste an average of $97 million of the total $1 billion investment due to poor project performance. So, a project manager needs to have ... Read More

Most project status meetings happen as part of an organization's tradition. The common lines we hear from a project manager while starting a project would mostly be “Mondays are for review meetings” or “Let’s meet every Wednesday to check on the project updates.” 90% of these status meetings could sail through emails or threads on internal communication platforms like Teams or Slack. That being said, we aren’t downgrading the importance of project status meetings. Instead, we’d like to emphasize how project managers and team members could conduct these meetings to ensure quality project deliverables. Why are Status Review Meetings ... Read More

Did you know? India will be in need of 7 million project managers by 2027. With organizations these days taking massive leaps into adopting ML, big data, automation, and AI; project managers shall play a vital role in implementing digital transformation projects effectively. To make a mark in this ever-growing and changing field of project management, obtaining a certification is vital in opening up the doors for your career advancement and higher earning potential. However, the cost of obtaining a certification can be a significant hindrance for many. But what if we told you that upskilling yourself through ... Read More