Your equipment is ordered. The schedule is set. The team travel plans are made. But are you ready to maximize your experience at the original equipment manufacturer’s factory floor? This post will review some key points to consider in maximizing the Factory Acceptance Testing (FAT) as part of the overall verification process.Read More
How can cloud computing be used in a highly regulated environment?
Pharmaceutical companies make huge investments in equipment, materials, and personnel to develop and manufacture life-saving products. The equipment that makes those products is designed, manufactured, and commissioned to a specific set of standards. There is an expectation that the equipment will continue to provide quality service within those parameters for a set amount of time and for a predictable cost. Yet we struggle to have confidence that our operational and capital expenditures will return the maximum value from our assets from the day they are qualified until their disposal.Read More
In many ways, today's pharma and biotech facilities share the same problem that many of the factories that supported the war effort during World War II had – a shortage of skilled and qualified operators and technicians. This lack of a skilled workforce in the early 1940’s was a crisis that the U.S. Government War Production Board responded to quickly with one of the first emergency services to be established: Training Within Industry or TWI. As many skill laborers went off to war, the service was designed to boost industrial production of war material born out of the need to rapidly train new, unskilled workers entering the war production workforce. The impact of TWI was instrumental to the United States’ victory in World War II, but it also had a far-reaching impact on the post-war rebuilding of Japan. Although this program was built on long accepted principles, it was very effective because managers and supervisors were “drilled” in “how to do it." It began with the recognition that the organizational environment and the organization’s management systems had to establish the framework by which humans are expected to succeed. TWI worked to solve a problem that the nation faced in the 1940’s by focusing on training unskilled workers and minimizing human error, and this remains the objective for the pharma and biotech workforce today.Read More
Sometimes projects are conducted as a series of disconnected efforts where each team from planning, design, construction, and testing views themselves as separate entities. With each trying to finish their portion of the work and get on to their next project. These “separate” efforts have goals to accomplish, and sometimes they regard each other as the obstacle to accomplishing those goals. The downstream team often feels that the upstream team doesn’t understand the difficulties they are experiencing and that they are just trying to throw the work product over the wall and claim success. The upstream team feels that the downstream team is too demanding and will not accept something less than perfection. Conflict ensues, and the overall program suffers.Read More
Until about 2016, the majority of vectors used in gene therapy were Adenovirus and Retrovirus vectors. In recent years, a change toward Lentivirus and Adeno-associated virus (AAV) vectors has occurred. This is reflected when looking at the numbers in current clinical trials underway in the gene therapy field.Read More