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Preventive Maintenance And Calibrations - Regulatory Expectations And Best Practices

This course strengthens the ability to build inspection-ready preventive maintenance and calibration programs that support equipment reliability, compliant documentation, and consistent manufacturing performance across FDA-regulated operations. This Course is designed for professionals responsible for equipment reliability, compliance oversight, maintenance systems, and regulated manufacturing operations.

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US $190 per learner

30-Days Unlimited Streaming Access

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REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Instructor : Meredith Crabtree
  • Study time : 90 Minutes
  • Skill Level: Intermediate
  • Course ID: TF3613
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Preventive maintenance and calibration activities directly influence equipment reliability, production continuity, product quality, and regulatory compliance within FDA-regulated industries. Ineffective maintenance practices, incomplete records, or poorly controlled calibration programs can increase operational disruptions and create significant inspection concerns. Organizations operating in pharmaceuticals, biotech, medical devices, laboratories, and related sectors must maintain documented systems that support cGMP expectations while sustaining consistent manufacturing performance and quality assurance objectives.


This course examines the operational and regulatory expectations associated with preventive maintenance and calibration programs, including documentation practices, training requirements, implementation considerations, and continuous improvement methods. The course addresses practical approaches for managing maintenance schedules, calibration procedures, equipment qualification considerations, and record-keeping activities that support inspection readiness. Real-world industry examples and common implementation challenges provide context for improving program consistency, reducing downtime, and supporting reliable production environments.

  • Inspection-Ready Maintenance and Calibration Practices:

    Participants will strengthen their ability to manage preventive maintenance and calibration activities in alignment with FDA-regulated operational expectations. The course addresses maintenance scheduling, calibration procedures, qualification considerations, and documentation practices that frequently receive regulatory attention during inspections. Greater control over these activities supports equipment reliability, reduces preventable operational interruptions, and improves consistency across manufacturing environments.

  • Operational Control Through Documentation and Continuous Improvement:

    Effective maintenance and calibration programs depend on accurate records, trained personnel, and measurable performance monitoring. This course explains approaches for maintaining maintenance logs, calibration certificates, and supporting documentation while reinforcing competency through structured training practices. Participants will also review continuous improvement methods, feedback mechanisms, and common implementation issues that can affect productivity, compliance consistency, and long-term operational performance.

Key Areas Covered

  • Regulatory expectations for preventive maintenance and calibration activities within FDA-regulated industries and cGMP environments
  • Preventive maintenance principles, equipment reliability considerations, and methods for reducing operational downtime
  • Calibration procedures, calibration frequency management, and equipment qualification or validation considerations
  • Documentation practices including maintenance logs, calibration certificates, record retention, and inspection preparedness
  • Program implementation methods, operational challenges, and practical considerations for maintaining compliant maintenance systems
  • Personnel training, competency development, procedural adherence, and continuous improvement approaches for maintenance programs
  • Real-world case studies highlighting implementation outcomes, lessons learned, and common maintenance and calibration issues
  • Operational efficiency impacts including productivity improvement, cost reduction opportunities, and reduced equipment failure risks

Who Must Attend

  • QA/QC Departments
  • Regulatory Affairs Departments
  • Documentation and Training Staff
  • Executive Leadership Teams
  • Auditing Teams
  • Training and Development team

Quality training, expert insights, and answers that matter. Know your Expert

MEREDITH CRABTREE

Meredith Crabtree has more than 30 years of experience across regulated industries including pharmaceuticals, medical devices, laboratories, blood and plasma operations, cosmetics, supplements, and animal health. Her background includes manufacturing, packaging, labeling, distribution, regulatory assessments, quality training, recall support, and Consent Decree activities. As owner of MLKC Consulting, she works extensively with quality systems, inspections, documentation practices, and compliance-related operational activities directly connected to preventive maintenance and calibration program management.

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Whether you’re looking for a single onsite workshop or a multi-team training series, we’ll help you design a program that fits your goals, timelines, and operational reality.

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Your organization deserves the confidence.

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Our students love us ❤️

“Support team was quite responsive before the session. That made it easier to get aligned internally. Presenter kept things simple, not overloaded.”

Supervisor, Training and Development

“Some good points came up during Q&A. That part was useful for us.”



Auditor, Compliance

“Pre-session communication was smooth. No confusion on access or timing.”



Officer, Regulatory Affairs

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