AM Technical Solutions (AM) is proud to introduce life sciences industry leader Scott Lessard as the new Vice President, Life Science. In his executive role, Scott is responsible for contributing to the growth of our Life Science division as well as other business units within AM. Scott brings more than 18 years of industry experience […]
Introducing Scott Lessard, Our New VP of Life Science Read More »
The AM Technical Solutions (AM) team is continuing to work on the convergent bioscience building project on the campus of the University of Southern California (USC) in Los Angeles. The project calls for architectural design, engineering, and cleanroom build-out for the new Michelson Center for Convergent Biosciences. This building will create a new platform for
AM Continues Support of Convergent Bioscience Project at USC Read More »
AM Life Science (AMLS) recently partnered with a Boston-area gene therapy company to insert a Commissioning Qualification and Validation (CQV) subject matter expert (SME) at the pre-construction/construction phase of the facility design/build project. The insertion of a downstream SME aligns with our unique approach to Quality by Design (QbD) called Early Quality Integration (EQI). Our
AMLS Provides QbD Solution for Gene Therapy Renovation Project Read More »
AM Life Sciences (AMLS) has completed and turned over work for upgrades to a New England pharmaceutical company’s Engineering and Commissioning, Qualification, and Validation (CQV) Lifecycle program for equipment and systems. AMLS led the effort by focusing on the principles identified in ASTM 2500 (version 13) Standard Guide for Specification, Design, and Verification of Pharmaceutical
AMLS Completes Upgrade of Engineering & CQV Lifecycle Program Read More »
AM Life Science (AMLS) promotes an approach to quality by design (QbD) that we call Early Quality Integration (EQI). The goal of this process is to better support biotechnology companies meet FDA requirements. We are now partnering with a Boston-area biotech company to insert a Validation and Quality subject matter expert (SME) at the pre-construction/construction
AMLS Introduces Our “Quality by Design” Approach to Biotech Project Read More »
AM Cleanroom Build and Performance (AMCBP) recently completed a cleanroom construction project for a medical device manufacturer in the Southwestern U.S. The medical device manufacturer required a compliant, safe, and efficient cleanroom to support the critical production of life-saving medical devices. A local, high-end construction company was in charge of the overall facility construction. AMCBP
AMCBP Completes Critical Cleanroom Construction Project for Medical Device Manufacturer Read More »
AM Cleanroom Build and Performance (AMCBP) recently completed a critical assessment of a 503B compounding facility in the Southwest U.S. region. AMCBP was asked to consult on the completion of a 503B facility to assess the potential risks from the perspective of certification and clean build. Our services were vital to support the facility construction
AMCBP Consults on 503B Compounding Facility Project Read More »
In 2011, the FDA implemented a Quality by Design (QbD) pilot program to support their review and approval process. After gathering several years worth of research, the FDA decided to push forward with a QbD approach to evaluate the manufacturing processes used by pharmaceutical companies. The central idea is to focus on improving control in
Quality by Design for FDA Approval: Building Control vs. Inspection Read More »
In 2011, the FDA implemented a Quality by Design (QbD) pilot program to support their review and approval process. After gathering several years worth of research, the FDA decided to push forward with a QbD approach to evaluate the manufacturing processes used by pharmaceutical companies. The central idea is to focus on improving control in
Quality by Design for FDA Approval: Building Control vs. Inspection Read More »
Quality by design (QbD) is often associated with construction projects. The idea is to develop processes that support quality throughout the construction project from planning to building to operations. In the pharmaceutical industry, the U.S. FDA has taken significant steps to adopt QbD principles in their pre-market processes that guide the approval process. In fact,
Quality by Design (QbD) in the Pharmaceutical Industry Read More »
