Compliant Maintenance

in the

Regulated Industry

A one day seminar that can help avoid weeks, months, or even years of regulatory distress!

Available at your site, on your schedule!

In order for a regulated company to maintain its validated state, it must maintain its equipment and facilities. Equipment that is not maintained is soon driven by the laws of nature into a state not covered by the original equipment qualification.

This “wearing out” is counteracted by compliant maintenance to help ensure the validated state of the equipment is continued.

This one day seminar will present requirements for Compliant Maintenance as part of an overall Quality System.  It will demonstrate how maintenance, as a component of the Facilities and Equipment System of the FDA Quality Systems Approach to inspections, is a major, though often unheralded, part of the overall compliance effort.

Quality System Elements

Quality System

Production System

Packaging & Labeling System

Materials System

Laboratory System

Facilities & Equipment System

Course topics include:

• Regulatory basis for maintenance and relationship to the validation effort
• The appropriate role for the Quality Unit
• Overview of Compliant Maintenance Activities
• The Preventive Maintenance Program – requirements for developing and approving PMs
• Executing PMs
• Corrective Work Order requests – How they should be generated and reviewed
• Executing, reviewing, and approving Corrective Work Orders
• Maintenance Metrics – how to avoid the numbers racket!
• Controlling spare parts and evaluating Functionally Equivalent Parts
• Equipment identification and files
• Qualification and training of in-house and contracted personnel and companies

By presenting the one day Compliant Maintenance Seminar at your site, you can avoid the travel and costs associated with that travel for multiple personnel. Plus you can have more people trained on the concepts of Compliant Maintenance then you may normally have the budget to send to an off-site course.  For example, if you sent four participants to an off site seminar at $1500 per person plus expenses and unnecessary lost time, the total cost could exceed $10,000!  That is more than twice as much as an onsite presentation and the onsite would have no limit on the number of attendees.

This seminar would be of value to:

Maintenance Management

Maintenance and Facilities Technicians

Operations Management

Quality Unit Personnel

Validation Personnel

Technical Support Personnel

This session has been presented twice at a single site over a two day period, dividing the interested personnel into two groups to allow for coverage of ongoing operations.

This seminar is relevant, interesting, and at times, humorous. It has always received accolades for the attendees and thought well worth the nominal expense.

The Course Leader

 Joseph T. Busfield is the Principal of Pharmaceutical Technical Services and has over 30 years experience in the pharmaceutical and related industries. His responsibilities have included: maintenance, instrumentation, utilities, project engineering, and validation for both oral dose and parenteral pharmaceutical manufacturing facilities and engineering companies. His experience in operating plants includes design, start up, validation and operation.

Joe has worked with clients under consent degree or other regulatory burden and others trying to avoid such problems. He always works to develop sustainable, pragmatic programs that will withstand regulatory scrutiny. His major emphases are in maintenance, calibration, engineering and general facilities related programs in the regulated health industry. His activities have been conducted throughout the US and Europe. He holds a B.S., (Mechanical Engineering) from Drexel University, and a M.B.A., (Management and Finance), from LaSalle University. Mr. Busfield has served as an adjunct professor at several colleges teaching management and math courses.

Proudly offered by:

PO Box 219

Warrington, PA 18976

USA

215.491.9355 (office)

215.882.3816 (mobile)

Focused consulting for the FDA regulated industry:

Engineering

Maintenance

Calibration

Engineering Change Control

Pest Control

Facilities Cleaning

Equipment Qualification.

www.PTSGMP.com

Training@ptsgmp.com