Blog
September 6, 2024 || Jon Thompson
The workforce is transforming rapidly, driven by technological advancements like Digital Twins. These virtual models replicate real-world systems in a digital space, and their integration into biotechnology is revolutionizing production processes and heightening regulatory compliance. Understanding Digital Twins Digital Twins are virtual replicas of physical systems, processes, or products. In…
September 5, 2024 || Robert Ossig
Transitioning from technology transfer (TT) to routine commercial production poses significant challenges for biopharmaceutical companies. Ensuring a seamless handover from the TT Team to the Receiving Unit (RU) requires meticulous coordination across multiple functions to mitigate risks and incorporate lessons learned. This blog explores the critical roles and activities involved…
August 21, 2024 || Brian Stephens
This is the last installment of a three-article series that presents several lessons learned by our validation team while completing a pair of validation projects using the methodology presented in the FDA’s draft of the Computer Software Assurance for Production and Quality System Software guidance (CSA). When the validation effort…
July 22, 2024 || Harry Benson
Let’s contrast two very real scenarios: You are responsible for bringing a new GMP facility or line to full-scale production. Your board or shareholders expect you to have thought of everything that requires funding without excessive capital or operational budget overrun. Based on your experience at a previous facility, you…
July 18, 2024 || Cody Beaumont
Originally issued in 2005, ICH Q9 laid down principles and examples of tools for QRM that can be applied throughout the product lifecycle. It was a groundbreaking step towards integrating risk management into pharmaceutical quality systems, encouraging a proactive approach to potential risks, and fostering a culture of continuous improvement.…
July 11, 2024 || Jeff Hall
In today’s rapidly changing market, companies must be agile and adaptable to meet fluctuating demands. Achieving operational goals amidst these changes requires flexibility in production planning and inventory management. CAI is here to help you develop streamlined processes that minimize downtime and maximize productivity, enabling a more efficient and responsive…
July 11, 2024 || Jeff Hall
The “People in Plant” (PiP) program is pivotal in recognizing and enhancing the contributions of employees in a pharmaceutical manufacturing facility. Implementing such a comprehensive initiative requires specialized expertise, strategic planning, and a nuanced understanding of both human resources and the pharmaceutical industry. This is where consultants play a crucial…
July 11, 2024 || Charles S. Logan
Intro: Assessing project performance is both an art and a science. A successful methodology in evaluating project health and performance is Earned Value Management (EVM). This methodology utilizes several factors to determine how well the project is being run: Planned Value (PV), Actual Cost (AC), and Earned Value (EV). But…
June 18, 2024 || Robert Ossig
Unlocking the Future: Exploring Cutting-Edge Cell and Gene Therapies The world of medicine is in the middle of a transformative evolution following the advent of cell and gene therapies. These cutting-edge treatments offer promising avenues for tackling diseases at their root causes, providing hope for conditions that were previously deemed…
June 11, 2024 || Robert Ossig
In the complex landscape of pharmaceutical and biopharmaceutical product development, the initiation stage of technology transfer (TT) is critical for ensuring successful scale-up and manufacturing. This stage involves a multidisciplinary approach, where business, technical, and regulatory considerations must be meticulously assessed to determine the feasibility and strategy for TT. Effective…
