Business continuity planning (BCP) is essential for the success of any enterprise, but it’s particularly crucial for companies in the life sciences industries, where criticality and compliance with FDA regulations may be impacted by a host of factors ranging from cybercrime to natural disasters to disruptions in the supply chain. Read more »
For companies in the Life Sciences industry, today’s climate—a mixture of competition, regulation, increasing consumer awareness, and continually evolving knowledge and capabilities—presents manufacturers of pharmaceuticals, medical devices, biologics, and combination products with a choice: maintain the status quo in product design, manufacture, and testing, or join the forward motion of the industry as well as the FDA in embracing the holistic and dynamic approach of Quality by Design (QbD). Read more »