Kells Alliance Consulting, LLC
John Feeney, Principal, specializes in designing efficient analytical laboratory operations that meet the compliance needs of FDA regulated industries.
EFFICIENT AND COMPLIANT LABORATORY MANAGEMENT
Create a successful integration of science, compliance and business needs in the laboratory. This will maximize productivity and compliance and improve employee moral and motivation. This will be done by:
-Assessing current practices in the lab to achieve operational objectives and compliant operations.
-Assisting in the design and implementation of new of enhanced practices as appropriate and relevant training for employees.
Advising on the implication of pending or proposed regulatory regulations.
DESIGN AND IMPLEMENTATION OF SOP’S AND DOCUMENTATION SYSTEMS
SOP’s and Documentation Systems are the key to operating a department in both an efficient and compliant manner. These systems will be strengthened or created by:
· Review and assessment of current SOPs and documentation systems for appropriateness, clarity and readiness for a Pre-Approval Inspection.
· Assisting client in elimination of inefficient SOPs or systems and creation of new and/or enhanced SOPs and systems as appropriate.
PROJECT MANAGEMENT
The role of the laboratory will be better defined in the overall R&D effort to bring new products to the market. This will increase throughput and eliminate organizational conflicts between departments. This will be achieved by:
Review of the current role and expectations of the department from within and its’ interactions with other departments.
Facilitating changes needed so that expectations and deliverables within the department and between departments are in alignment.
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION
The analytical test methods and their validation will be strengthened and made more efficient and compliant for use by:
· Review of methods and validations to determine their suitability for their intended use from both a scientific and compliance framework.
· Troubleshooting existing problems.
· Advising client on redeveloping and / or choosing methods that are more suitable for their intended use.
· Advising client on additional validation or more efficient validation as appropriate.
STAFF DEVELOPMENT
Enhance the capability, motivation and productivity of the staff by:
Evaluating the current training and education of the staff in view of current or intended department operations and goals.
Advise and assist in providing additional training / education as appropriate.
EFFICIENT AND COMPLIANT LABORATORY MANAGEMENT
Create a successful integration of science, compliance and business needs in the laboratory. This will maximize productivity and compliance and improve employee moral and motivation. This will be done by:
-Assessing current practices in the lab to achieve operational objectives and compliant operations.
-Assisting in the design and implementation of new of enhanced practices as appropriate and relevant training for employees.
Advising on the implication of pending or proposed regulatory regulations.
DESIGN AND IMPLEMENTATION OF SOP’S AND DOCUMENTATION SYSTEMS
SOP’s and Documentation Systems are the key to operating a department in both an efficient and compliant manner. These systems will be strengthened or created by:
· Review and assessment of current SOPs and documentation systems for appropriateness, clarity and readiness for a Pre-Approval Inspection.
· Assisting client in elimination of inefficient SOPs or systems and creation of new and/or enhanced SOPs and systems as appropriate.
PROJECT MANAGEMENT
The role of the laboratory will be better defined in the overall R&D effort to bring new products to the market. This will increase throughput and eliminate organizational conflicts between departments. This will be achieved by:
Review of the current role and expectations of the department from within and its’ interactions with other departments.
Facilitating changes needed so that expectations and deliverables within the department and between departments are in alignment.
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION
The analytical test methods and their validation will be strengthened and made more efficient and compliant for use by:
· Review of methods and validations to determine their suitability for their intended use from both a scientific and compliance framework.
· Troubleshooting existing problems.
· Advising client on redeveloping and / or choosing methods that are more suitable for their intended use.
· Advising client on additional validation or more efficient validation as appropriate.
STAFF DEVELOPMENT
Enhance the capability, motivation and productivity of the staff by:
Evaluating the current training and education of the staff in view of current or intended department operations and goals.
Advise and assist in providing additional training / education as appropriate.