CGMP VALIDATION® - Key Persons

Job Titles:

• Chief Operating Officer

Christopher serves cGMP Validation, LLC as Chief Financial Officer. He is responsible for overall finance, billing, and accounts receivables.

Job Titles:

• Director
• Director of Validation & Compliance Services

Dave is a Director and has been with cGMP Validation since its founding. Dave is responsible for management, planning, coordination, and procurement activities for cGMP Validation. On a project level, he is also responsible for meeting validation project goals and objectives and managing project personnel to meet timelines and budget. In addition to his responsibilities for the coordination and execution of commissioning and validation activities, Dave also provides guidance and performs periodic GMP audits for clients. Dave has been in the pharmaceutical and biotechnology consulting industry since 1993. As an experienced director and project manager, he has successfully completed numerous projects for multiple pharmaceutical, biotech, medical device, and animal health facilities. Dave has a thorough understanding of FDA and USDA expectations and industry standards. He has managed projects utilizing a variety of qualification approaches including ASTM E 2500 verification, commissioning and qualification (C&Q), and traditional IQ/OQ/PQ validation. This breadth of experience allows him to easily adapt and tailor a project approach to work within a client's existing validation program. Dave plans activities of designated projects to ensure that objectives are accomplished within the prescribed time frame and funding parameters and is able to skillfully coordinate work schedules and staffing of personnel for each phase of the project. Dave is particularly attentive to detail in identifying problems, diagnosing causes, and determining corrective actions.

Job Titles:

• Chief Operations Officer
• Engineer
• Senior Director of Validation and Compliance

Jeremy is the Chief Operations Officer, responsible for the management, planning, coordination, procurement activities of projects, and business development the for cGMP Validation. On a project level he is also responsible for meeting validation project goals and objectives and managing project personnel to meet timelines and budget. Jeremy is responsible for the coordination and execution of validation activities as well as providing periodic GMP audits and regulatory guidance for clients. Jeremy is an Engineer with many years of construction and project management experience. He has over 10 years' experience working in the Commissioning and Validation field. He has successfully completed many projects up to $100M and managed teams of over 80 full time employees. He has a strong technical background. As an experienced Project Manager and Director, he has successfully completed numerous projects for multiple pharmaceutical, biotech, and medical device facilities. Jeremy has managed projects utilizing a variety of qualification approaches including ASTM E 2500 verification, commissioning and qualification (C&Q), and traditional IQ/OQ/PQ validation. In addition to coordinating team activities and managing projects, Jeremy assists clients in building validation and compliance programs. He has an excellent understanding of industry standards; therefore, enabling him the tools to provide practical and cost effective approaches to validation and compliance.

Job Titles:

• CEO
• President
• President and CEO of CGMP Validation LLC

Jesse serves as the President and CEO of cGMP Validation LLC. He is responsible for overall company activities and the well being of the company.

Job Titles:

• Vice President CGMP Validation, LLC

Laura serves cGMP Validation, LLC as Vice President. She is responsible for management, coordination and execution of validation activities as well as providing periodic GMP audits and compliance guidance for clients as well as overall HR, benefits, training, and quality assurance for the company.

Job Titles:

• Director - Computer Validation CGMP Validation, LLC

Since joining cGMP Validation, LLC in February 2001, Phil has been responsible for leading a team of processionals that specialize in providing full-service validation of GxP relevant computerized information systems, including manufacturing, laboratory, logistics, and electronic record management applications. As a Director, Phil is responsible for all marketing, sales, technical, regulatory compliance, and commercial aspects of the projects the team performs, and is accountable internally for effective personnel and financial management.

Job Titles:

• Compliance and Computer System

Todd is cGMP Validation's Compliance and Computer Systems Validation Director, responsible for business development, project organization and management of this sector of our business. As projects are preparing to start, Todd builds project plans for our clients which include timelines and milestones with budgetary tollgates for measuring project progression. He is also often in the field functioning as a liaison with our clients to observe project execution, manage project changes and ensure our team is on schedule. Todd is a compliance expert experienced in high level staff augmentation, designing and implementing compliant Quality Systems under 21 CFR, parts 111, 210, 211, 212, 820 and 1271. Compliance services span across industries such as medical devices, nutraceuticals, pharmaceuticals, radiopharmaceuticals, biologics and homeopathic medicines manufacturing. Computer system qualifications include large systems such as Master Control, Siemens Metasys and Syspro electronic batch records, to smaller systems such as TempAlert passive environmental monitoring. He has been directly involved with multiple green-field build teams providing compliance oversight of building design and startup operations. He has over 15 years of industry experience working in regulated environments and over 25 years progressive management expertise while serving on active duty.