View stunning SlideShares in full-screen with the new iOS app!Introducing SlideShare for AndroidExplore all your favorite topics in the SlideShare appGet the SlideShare app to Save for Later — even offline
View stunning SlideShares in full-screen with the new Android app!View stunning SlideShares in full-screen with the new iOS app!
High Performance Teams Make the Difference. COMMISSIONING AGENTS, INC. PROFILE Commissioning Agents, Inc. (CAI) provides integrated validation, qualification and commissioning services for technology intensive capital projects and building construction. Our services include validation and commissioning planning, management, and field execution for biotech/pharmaceutical manufacturing facilities and laboratories, and Building Commissioning and LEED Cx services for educational, healthcare, government and private facilities, and data centers. We also provide regulatory compliance consulting, maintenance program development, SOP and training development, and computer software development and validation. PRODUCING BENEFITS FOR OUR CLIENTS We are driven to ensure the owner’s project requirements are met by the delivered equipment and facilities. We are specialists in the validation and commissioning profession. It is what we do; it is who we are. We understand current industry practices and regulatory expectations for qualification documentation and approaches. We are at the forefront of industry improvement efforts (ISPE, ASTM). Our people know how equipment must operate to perform as a system, and how systems must integrate to meet end-‐user requirements. Our clients frequently comment on how we, apart from any other contractor they have experienced, put their interests first and go the extra mile to help deliver their project on target, on budget, and on schedule. AT-‐A-‐GLANCE Founded: 1996 Cumulative services rendered: $210 million 2010 sales: $27.75 million Full time employees: 181 (175 Technical Professionals; 6 Administrative) Ownership: 100% employee-‐owned through an employee stock ownership plan (ESOP). Over half of the capital is allocated to United States veterans, who comprise more than half of our employees. The vast majority of company management consists of veterans, along with half of the board of directors. Our workforce is distributed throughout the United States and Puerto Rico, as indicated by the map.
High Performance Teams Make the Difference. ORGANIZATIONAL CHART
High Performance Teams Make the Difference. CORE SERVICES Commissioning Agents, Inc. (CAI) provides a variety of commissioning and validation services. Furthermore, we specialize in providing services for technologically sophisticated, biotech/ pharmaceutical manufacturing facilities, healthcare facilities and laboratories. COMMISSIONING Services include (but are not limited to): Requirements development Planning and schedule development Design and submittal reviews Pre-‐delivery inspections Factory and site acceptance (FAT/SAT) support Equipment receipt and installation inspections Construction quality oversight/ in-‐process inspections Execution coordination/ management System start-‐up/ shakedown / troubleshooting Functional and performance testing System manuals/ turnover packages Warranty reviews Document verification DCS, BAS/ BMS, and PLC Installation Checkout VALIDATION Process validation Cleaning validation Sterilization validation Master plans PRODUCTION SUPPORT Maintenance and calibration programs QUALIFICATION SOP development Protocol execution Training Automation validation Risk assessments Facilities, utilities, process equipment Process efficiency studies IQ/OQ/PQ protocol development cGMP compliance audits, improvement Final reports and remediation support IT systems validation Process analytical technology Lab equipment implementation
High Performance Teams Make the Difference. BUILDING CX SERVICES INDEPENDENT OBJECTIVITY Commissioning is our core competency. We work in cooperation with architects and engineers, Client Managers and other team members involved in a project to ensure specifications are met, keeping projects on schedule. We have excelled as a technically competent, independent commissioning authority for over 14 years. Commissioning Agents has provided over $160 million in technical services, and have been engaged in over 1800 separate projects. We implement our “whatever it takes” work ethic to every project to ensure successful completion. Our Services Include: Commissioning Planning COMPREHENSIVE SERVICES Design Review Our comprehensive services include all aspects of commissioning for Protocol Development new and existing buildings, manufacturing and health care facilities, Construction Quality Assurance power plants and other projects requiring assurance that construction Commissioning & Start-‐Up and performance specifications are met. Whether a project involves Project Delivery Management getting a new facility in operation, adding a piece of equipment or retro-‐ Instrumentation commissioning an existing building, Commissioning Agents, Inc. provides a comprehensive set of essential services to complete your project. Meeting Expectations: “Your employees worked long hours, demonstrated excellent teamwork HIGH PERFORMANCE TEAMS and communicated effectively with It is critical to have a well-‐oiled, efficient team of professionals who are all team members to get the work familiar with our procedures, each other and the work requirements. All done. Above all, they are great to of our employees are full-‐time, permanent workers – not contract work with and we certainly look forward to working with CAI again in employees thrown into an unfamiliar situation. As a result we provide the near future.” clients with a highly effective performance team. For each specific project we field a specialized team with appropriate core competencies. Our staff includes professionals with diverse skills. TAILORED SOLUTIONS Each project has different requirements based on the technical complexity and owner’s requirements. We tailor our level of service to the nature and needs of each project to ensure the owner receives a fully-‐functional facility.
High Performance Teams Make the Difference. INDUSTRY SEGMENTS Commissioning Agents, Inc. serves Fortune 500 companies (and some that will be in the future). Our clients include some of the largest pharmaceutical companies in the world. We also serve smaller companies and start-‐ups that are ready to launch their first product. Due to our performance and high degree of customer satisfaction, more than 90% of our business is from repeat clients. GMP QUALIFICATION/VALIDATION Pharmaceutical Biotechnology Medical Devices Combination Products GMP COMPLIANCE & PRODUCTION SUPPORT Pharmaceutical Biotechnology Medical Device Combination Products Food manufacturing Cosmetic manufacturing COMMISSIONING Educational Facilities Health Care Facilities Pharmaceutical Biotechnology Medical Device Semiconductor Facilities Combination Products Commercial Buildings/ Facilities Power Generation Facilities Process (chemical) Manufacturing Industries Fabrication/ Assembly Manufacturing Industries
High Performance Teams Make the Difference. OUR COMMITMENT TO QUALITY Commissioning Agents, Inc. has developed a program of skill and knowledge based qualification and continuing education at industry conferences and training courses. This instruction enhances staff confidence, allowing them to work capably on a wider variety of project assignments and increasing job and personal satisfaction. Completing this competency development program also allows our staff to provide extra value to projects. In short, we don’t just apply “bodies” to a project – we apply capable people who will add value to your project team from day one. Our Qualification Program has the following levels: Tier I/II: Basic knowledge of industry and core services. Consists of oral check-‐outs and written final examination. 6 months to complete. Tier III Project Management Administration: Knowledge of procedures for managing a project, including basic scheduling and earned value. Consists of oral check-‐outs and written final examination. Tier III Technical: Consists of oral check-‐outs, required reading, required training course attendance, a project experience (varies from 1200 – 4000 hours). Final written examination. Tier IV: Customized program of advanced capabilities.
High Performance Teams Make the Difference. THE COMMISSIONING AGENTS, INC. CULTURE Commissioning Agents, Inc. invites only top candidates to join our team. We provide them with challenging assignments, and encourage professional development and growth. This formula for retaining capable and highly motivated people has proven successful. Our staff comes from a variety of backgrounds. More than half of the staff served in the Navy as a nuclear-‐trained officer or technical specialist. As a result of this training we understand how to develop and use written procedures for testing, maintenance, and operations, and have integrity and a solid work ethic that allows us to learn new equipment and systems quickly. During commissioning work we utilize our experience to identify aspects of the installation or operation that may not be part of the protocol, but could cause operational issues later. Commissioning Agents is proactive in troubleshooting to correct issues in concert with the vendor or construction manager. We also have several key people with over 20 years working for pharmaceutical manufacturers in validation and quality assurance positions. DIFERENTIATING OURSELVES Our customers tell us we stand apart from other contractors for two reasons: 1. We help fix and, more importantly, drive issues to completion. We will attempt to foresee and minimize and/or avoid road-‐blocks to get problems retested properly, with documentation, to meet expectations. 2. We do what is in the customer’s best interest, even when it may not be in our best interest. Our internal quality system will ensure that our deliverables are professional and free from grammatical, spelling and document formatting errors prior to submittal. Our field quality program delivery method addresses all issues in a 3-‐tier solution to drive issues to immediate resolution. This program works as a cooperative team with our client, engineers and contractors. Moreover, we will consider schedule, client requirements and project costs while keeping an eye on the targeted results.
High Performance Teams Make the Difference. EARNING A SOLID REPUTATION Customers routinely provide us with unsolicited, positive feedback on the performance of our teams because we remove hurdles and roadblocks while others wait for them to be removed. We facilitate progress, while others are busy documenting why they can’t make progress. Some of this feedback includes: "There were numerous contractors (i.e., no one company had total responsibility) and you (CAI) were able to get them all to work as a team with a common goal. Your team leader stepped into a very difficult position as the C & Q lead of a very dysfunctional team. He was able to calm the "noise" and get the team focused on execution. The Commissioning & Q/CSV program was well integrated and quite successful.” “We have been very impressed with CAI’s commitment to getting the job done with your ‘whatever it takes’ attitude.” “After working with various commissioning/ qualification contractors, my experiences with CAI have been the most effective and rewarding. With past contractors, I have been the one to educate their team. It has been a relief to receive an education from the validation experts.” “I have had the opportunity in my seven years as department manager to have worked with numerous other contract services organizations; by far, Commissioning Agents proved the best value to me and my company.” CREATING CUSTOMER SATISFACTION Commissioning Agents, Inc wants to partner with you on future projects. We strive to elicit a positive reaction about our work from each and every client. Because of our reputation, dedication, and unique way of training and fielding a high performance team, we are your best choice to partner with for the successful completion of projects. We are awarded nearly 90 percent of work requested from repeat customers, and we look forward to the opportunity to earn additional repeat customers.
High Performance Teams Make the Difference. STRONG PERFORMANCE = SOLID GROWTH PREMIER PROVIDER Commissioning/Validation is our primary line of work. We are currently engaged as either the sole or lead commissioning contractor at 10 major projects, for 5 different Fortune 500 companies. The capital budgets for these major projects exceed $2 billion, with the commissioning service contracts totaling more than $20 million. With current annual sales of nearly $28 million, we have the skilled resources and financial strength to tackle a wide range of projects: any size, in any location around the world. GROWTH STRATEGY We grow only as fast as we can hire top quality people, and properly train and assimilate them into our project teams. Some of our competition will provide an experience project manager and one or two current employees, and then hire the remainder of the team. We believe this strategy does not serve a client’s best interest, even when it results in a team of mostly local people. In our line of work, we believe it is critical to have a well-‐oiled, efficient team of people, most of whom are familiar with each other and with the work requirements. Hence, we provide 70 – 90% of any project team from our current staff. We carefully select the projects we accept to ensure we meet our commitments and provide a positive project experience. Our growth occurs as a result of exceeding client expectations, which lead to more and larger projects. Commissioning Agents, Inc.’s reputation is spreading, leading to new business opportunities, which we translate into professional growth opportunities for our people.