Introduction to Life Science Calibration
Instructor: Marcus McNeely

This 2-day training course is designed for people new to calibration or who need to have a good understanding of the principles of calibration. The training provides a firm understanding of the FDA requirements for calibration and the best pracices for satisfying them.

Introduction to Biotech Calibration
Instructor: Marcus McNeely

This 2-day training course is a spin-off of the 'Introduction to Life Science Calibrations' course with examples specific to the biotech industry. It is designed for people new to calibration or who need to have a good understanding of the principles of calibration. The training provides a firm understanding of the FDA requirements for calibration and the best pracices for satisfying them.

Best Practices for Calibration in Life Sciences
Instructor: Marcus McNeely

This 2-day training course provides an in-depth treatment of calibration in life sciences, including the industry's best practices, and assumes a basic understanding of the principles of calibration. Although there is some overlap, for a quick jump start into calibration, this course in combination with the Introduction course is a practical option.

Facilities and Equipment Subsystem of QSIT
Instructor: Joe Busfield

Although often underemphasized, to ignore the Facilities and Equipment subsystem of the FDA’s Quality System Inspection Technique is to place a site’s production at regulatory risk. This seminar will establish the components of the Facilities and Equipment Subsystem, the importance of this Quality System element and an overview of the basics needed to meet regulatory and general good manufacturing requirements. Included will be an outline of facility equipment qualification, cleaning, performance qualification, maintenance, and calibration requirements.

GMP Maintenance Excellence
Instructor: Joe Busfield

Maintenance programs have long been identified as being a critical component of any efficient operation. Maintenance in FDA regulated industries takes on additional importance because of the role it plays in the validation and production processes of a quality product.

This one day seminar stresses the importance of maintenance activities in the regulated environment and emphasizes how critical it is to remain focused on maintaining the validation of the equipment and facilities when they were started-up. On-going maintenance activities should not impact negatively on the validated state.

Individuals who are responsible for, or involved with, any aspect of the maintenance, quality, calibration, validation or compliance of assets will reinforce their job performance by attending this class.

Previous course attendees have included: Plant Supervisors, Facility and Maintenance Engineers, Maintenance Supervisors, Validation/Compliance Officers, Support Engineers, Outside Contracted Maintenance Personnel such as Electricians, Plumbers, and Mechanical Services.

Managing Compliance Processes for Maintenance in Life Sciences
Instructor: Marcus McNeely

With the FDA's new focus on quality systems, greater attention now needs to be paid to how compliance processes are managed within the maintenance discipline. In many cases, these compliance processes will need to be harmonized with the processes and requirements of other departments, including calibration, validation and quality control. Once the compliance requirements are firmly understood, the challenge remains to develop compliance processes that do not negatively impact productivity. This 2-hour web training will present the compliance processes required in maintenance and approaches for implementing those processes while still maximizing productivity.

Developing a Sound Calibration Program web training
Instructor: Marcus McNeely

This web training, a part of the larger Best Practices for Calibration in Life Sciences curriculum, discusses the development of the components of a calibration program, including elements of a master plan, program and calibration SOPs and documentation.

Determination of Process and Calibration Tolerances and Correcting OOT
Instructor: Marcus McNeely

This web training course discusses approaches for determining proess and calibration tolerances and strategies for correcting out of tolerance conditions and reducing OOT occurences.

Asset Validation 101
Instructor: Marcus McNeely

This web training course provides an introduction to the requirements and expectations for validation management of instruments and equipment in the life science industries.