Preventive Maintenance and Calibrations – Regulatory Expectations and Best Practices

FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. Prior to use, however, this equipment must be validated to make sure it produces a product that meets its specifications. There are ways, though, to validate equipment already in use.

This webinar will provide instruction on how to establish and maintain a Maintenance & Calibration program for medical device and pharmaceutical instrumentation & equipment.

Areas Covered in the Session :

  • Definitions and Regulatory Expectations
  • Preventive Maintenance Requirements
  • Equipment Calibration Requirements
  • Calibration vs. Maintenance: When to use Which One?
  • Intervals for maintenance and calibration.
  • Maintenance and calibration procedures.
  • Remedial Action for Out-of-Calibration Equipment
  • Use of Calibration Standards for Efficiency and Accuracy

Who Should Attend:

  • Quality Departments
  • Engineering Departments
  • Research and Development Departments
  • Production Departments
  • Manufacturing Departments
  • Validation Departments
  • Operations Departments
  • Design Engineers
  • Reliability Engineers
  • Calibration Technicians
  • Maintenance Personnel

FDB3524

HitendraKumar Shah

HitendraKumar Shah is a renowned Quality oriented professional with over 20 years of experience in Quality Assurance and Quality Control. During this period, he has been actively involved in process control, Finished product release, Investigations, product recalls and other quality notifications. He has helped numerous companies in ensuring CAPA implementation & effectiveness, Quality system review and reporting, Supplier audit, GMP training, risk assessment and validation activities. His Key Competencies are but not limited to Quality Compliance, Vendor Audit, data integrity, Risk assessment, Qualification & validation, Review and finalization of technical agreements. He is a popular figure on social media for his effective and easily understandable training bites.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance