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Maintenance: Reliability, Engineering and Asset Management
Maintenance: Reliability, Engineering and Asset Management
Maintenance: Reliability, Engineering and Asset Management
Do you have a framework for a risk-based approach for maintenance systems or component best practices? Maintenance programs have long been recognized as critical to the success of the operations they support. Maintenance has the potential to affect both the quality of products and the compliance of pharmaceutical processes. This course provides a practical and consistent interpretation of the necessary elements of a pharmaceutical maintenance program, while offering maximum flexibility to enable widespread adaptation and encourage innovation to minimize the total cost of asset ownership.

The term 'non-cGMP', when applied to components, systems, or equipment indicates that the components, systems, or equipment - based upon risk assessments - are unlikely to impact product quality since potential risk can be managed to an acceptable level. This course leverages the content and templates from the ISPE Good Practice Guide: Maintenance to provide the tools for the development, implementation, and execution of cost-effective compliance for new or existing maintenance programs in a pharmaceutical manufacturing environment. In addition, the course promotes the concept that maintenance performed on any physical asset should only be performed if it addresses a potential failure mode. The course defines roles and responsibilities across cross-functional areas and recommends a systematic approach aimed at continuous improvement of maintenance operations.

*Note*: this course does not cover Calibration or cleaning which is addressed within other ISPE Guidance documents and training courses.

Immediately apply the course learning objectives with an electronic download of the ISPE Good Practice Guide: Maintenance.

Course Modules/Learning Objectives

Module 1: Introduction, Philosophy, and Key Concepts
  • Review key concepts
  • Discuss the maintenance program
Module 2: Basic, Good and Best Maintenance Practices
  • Discuss Maintenance Basic Practices
  • Discuss Maintenance Good Practices
  • Discuss Maintenance Best Practices
Module 3: Maintenance Program
  • Describe key aspects of a maintenance program
  • Discuss the system maintenance strategy
  • Explore types of maintenance
Module 4: Maintenance Management & Work Execution
  • Determine maintenance processes and controls
  • Identify work order management processes
Module 5: Roles, Responsibilities, and Interfaces
  • Examine the differences between various roles and responsibilities
  • Provide an understanding of the relationship between the maintenance unit and operation
  • Provide an overview of maintenance and regulatory requirements generally covered by EHS
Attendance Suggested For
  • Individuals working at manufacturing and operating companies including traditional pharmaceutical and biopharmaceutical; contract and generic manufactures, veterinary, medical device, bulk and API.
  • Engineering, validation, qualification and commissioning, facilities and equipment personnel.
  • Service providers including engineers, validation, suppliers and regulatory agencies and equipment and components suppliers.

Reviewer Biographies

Robert Christman has more than 25 years' experience in reliability, maintenance, and process engineering supporting pharmaceutical and biotech manufacturing operations. He is a Certified Maintenance and Reliability Professional (CMRP) and a Certified Plant Maintenance Manager (CPMM) and holds an MS in Chemical Engineering and a BS in Chemistry.

David J. Mierau, PE, CMRP, is a global reliability engineering and asset management consultant focused on the pharmaceutical and biotech industries. Past experience includes the site engineering & maintenance leader for one of the largest biotech pharmaceutical sites in the world, as well as other management and technical engineering support roles within Merck and Eli Lilly supporting a wide range of products and processes. David also has equipment and system design experience for critical utilities, packaging and production unit operations.
Discounted member price: 400.00
Your price: 500.00
You could save 20.0%
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This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessments to measure your comprehension and the ability to start and stop at any time, beginning where you left off.

ISPE CEUs are provided once you achieve an 80% passing grade and complete the evaluation.

Approximate Course Duration: 240 minutes (this is a self-paced course)

*NOTE* You will have 14 calendar days to access and complete this course from time of purchase.

ISPE CEUs: .40 ISPE CEUs will be awarded upon successful completion of grading requirements

Member Price: $ 400.00 / € 365.00
Non Member Price: $ 500.00 / € 440.00
Item #: WEBTRMAINTUS