CAI Appoints Sheena Dempsey as Chief Executive Officer
Indianapolis (October 2, 2024)—CAI, a global professional services firm and trailblazer in operational readiness and excellence, today announced Sheena Dempsey as Chief Executive Officer (CEO)....
Read MoreThe Handover Stage of Technology Transfer: Ensuring a Seamless Transition for Commercial Production
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...
Read MoreLESSONS LEARNED FROM IMPLEMENTING THE FDA’s CSA GUIDANCE: PART 3 –SUMMARIZING
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...
Read MorePlanning for a Talented Workforce: Building a Staffing Plan for New or Expanding GMP Facilities
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...
Read MoreICH Q9 Revision 1: Updates to Enhance Quality Risk Management in the Pharmaceutical Industry and a Pathway to a Robust Contamination Control Strategy
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...
Read MoreAchieving Operational Goals with CAI
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...
Read MoreLeveraging CAI Human Performance Services for the “People in Plant” Program: Driving Excellence in Pharmaceutical Manufacturing
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...
Read MoreEarned Value Management – Use It or Lose It!
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...
Read MoreThe Readiness Stage Of The Technology Transfer Process
During a pharmaceutical technology transfer (TT) project, the Readiness Stage plays a pivotal role by establishing the groundwork for a successful transition. This phase involves...
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