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.
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.
Contract manufacturing is on the rise, with companies from Apple to Xerox outsourcing production of their branded products. The approach is associated with several benefits like reducing overall costs and allowing companies to concentrate on core strengths like product design and marketing.
When giving negative feedback, supervisors often rely on what’s called the “sandwich” technique. We’ve all seen it. The email that goes something like this: “Hi Joe, Thanks for the extra hours last week wrapping up that project. You’re a great team player, but I’m going to need you to go ahead and add more detail to your Job Safety Analyses (JSAs). Anyways, thanks for everything, we really appreciate it.
A survey published in Pharmaceutical Outsourcing magazine reveals growing demand for contract manufacturing in the pharmaceutical industry, with over 75% of respondents indicating that they outsourced the same or more than in previous years.
There are many challenges facing the biotech industry today. Many issues—like those discussed below—are more fundamental, requiring a proactive approach to meet them head-on.
