Critical Mass Consulting
Critical Mass Consulting is a premier life sciences consulting firm dedicated to building its people and improving its clients' operations. They leverage experienced consultants, project leaders, and Subject Matter Experts to optimize operations, achieve business objectives, and support clients through various stages of development. Their services include validation, project management, engineering, quality compliance, and phase-appropriate quality management systems, all aimed at navigating regulatory landscapes and accelerating time to market.
Industries
Nr. of Employees
small (1-50)
Critical Mass Consulting
Oakland, California, United States, North America
Services
End-to-end CQV consulting covering commissioning, qualification, testing, validation program development, and integration of digital validation systems.
Program and project management using Agile methodologies for facility startups/shutdowns, capital projects, remediation, change management, and organizational development.
Engineering support including feasibility studies, specification development, cycle development, process capability optimization, program management, and decommissioning.
Development and implementation of quality systems, audits, change control management, supplier quality agreements, data integrity programs, and environmental monitoring programs.
Design of right-sized QMS frameworks and scalable roadmaps tailored to an organization's current development phase and growth objectives.
End-to-end CQV consulting covering commissioning, qualification, testing, validation program development, and integration of digital validation systems.
Program and project management using Agile methodologies for facility startups/shutdowns, capital projects, remediation, change management, and organizational development.
Engineering support including feasibility studies, specification development, cycle development, process capability optimization, program management, and decommissioning.
Development and implementation of quality systems, audits, change control management, supplier quality agreements, data integrity programs, and environmental monitoring programs.
Design of right-sized QMS frameworks and scalable roadmaps tailored to an organization's current development phase and growth objectives.
Expertise Areas
- Commissioning, Qualification, and Validation (CQV)
- Quality Management System (QMS) design and implementation
- Computerized System Validation and digital validation
- Project and program management for life sciences
Key Technologies
- Commercial digital validation platforms
- Computerized system validation (CSV)
- ASTM E2500-style risk-based validation methodologies
- Computer Software Assurance (CSA) approaches
News & Updates
Wednesday, July 10, 2024, 4:30 PM - 5:30 PM. It all begins with an idea. The event encourages sharing creative projects and stories online.
Thursday, July 11, 2024, 4:30 PM - 5:30 PM. It all begins with an idea. The event encourages sharing creative projects and stories online.
Friday, July 12, 2024, 4:30 PM - 5:30 PM. It all begins with an idea. The event encourages sharing creative projects and stories online.
Saturday, July 13, 2024, 4:30 PM - 5:30 PM. It all begins with an idea. The event encourages sharing creative projects and stories online.
Sunday, July 14, 2024, 4:30 PM - 5:30 PM. It all begins with an idea. The event encourages sharing creative projects and stories online.
An article discussing the challenges in GMP construction and validation timelines.
Wednesday, July 10, 2024, 4:30 PM - 5:30 PM. It all begins with an idea. The event encourages sharing creative projects and stories online.
Thursday, July 11, 2024, 4:30 PM - 5:30 PM. It all begins with an idea. The event encourages sharing creative projects and stories online.
Friday, July 12, 2024, 4:30 PM - 5:30 PM. It all begins with an idea. The event encourages sharing creative projects and stories online.
Saturday, July 13, 2024, 4:30 PM - 5:30 PM. It all begins with an idea. The event encourages sharing creative projects and stories online.
Sunday, July 14, 2024, 4:30 PM - 5:30 PM. It all begins with an idea. The event encourages sharing creative projects and stories online.
An article discussing the challenges in GMP construction and validation timelines.