Drug companies are constantly grappling with complicated changes in their industry. Those that are quick to identify new pharmaceutical risks and develop policies and procedures to mitigate them can reduce their exposure in an ever-changing landscape. Several important industry trends are reshaping the sector’s future, and we characterize these as the 7 deadly risks of pharma.
Risk has always had an implicit role in ISO standards, but newer versions are giving risk a more prominent place in quality and environmental management standards. Updated standards like ISO 9001:2015 and 14001:2015 require companies to apply risk-based thinking to a variety of processes across planning, operations and performance evaluation.
In compliance management, the role of managing and tracking nonconformances is a critical step to ensuring that product defects are flagged and handled properly. Whenever there is a product that differs from plans and specifications, something must be done. Typically, it will be flagged as a nonconforming material.
We recently wrote about what makes an effective Emergency Response Plan (ERP), and step 5 focused on the importance of drills and exercises. Today, we’re going to talk about what you need to have in place before you exercise your plan, so you can make sure that exercise is productive.
Food Safety Modernization Act (FSMA) compliance dates are approaching, with many companies required to establish a food safety system that analyzes hazards and implements risk-based preventive controls.
Risk assessment is a critical component of good quality management. Here are 4 risk assessment tools every quality pro should have in their toolbox.
Supply chain failure is considered a top threat to life science companies, second only to intellectual property theft. Despite the risks, the market for contract manufacturers continues to grow at a rapid pace. In fact, experts predict the global contract manufacturing market for pharmaceuticals will exceed $79 billion in 2019.
It can be difficult for quality managers to get budgets approved for new investments in quality, whether we’re talking about an automated Quality Management System (QMS) or a new ISO certification effort.
Building a tightly integrated supply chain is a strategic imperative for many pharmaceutical and medical device manufacturers today. In some cases, the supply chain itself provides a competitive advantage, especially for market leaders who use hundreds of suppliers to produce 30% or more of their products.
Recalls over product defects are a major concern in many industries, often creating millions of dollars in costs and brand damage. Part of the problem is that so many companies don’t effectively integrate Risk Management into their processes, allowing small issues to persist unmanaged.
Fun at work can be elusive. Everyone has a job to do, and safety and quality are serious matters. Fun with sustainability may sound even more questionable. In fact, you probably think I’m about to launch into a list of ways you can repurpose your old yogurt containers. But I won’t bore you with tired ideas that sound like they came from someone’s third-grade art class. Instead, here 5 ways to make workplace sustainability fun, and not totally annoying.
Two things are true when it comes to making important decisions that impact your company. One, you need a way to quantify risk to make the best choice, and two, you need to be able to explain that choice.
