Equipment Maintenance

PDF Edition - Equipment Maintenance, Calibration and Cleaning: A Guide to FDA Inspections

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July 2013
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Problems with equipment maintenance, cleaning and calibration are among the FDA’s most commonly observed deficiencies. If you want to avoid these issues and reduce risk you need this report.

This authoritative management report offers a comprehensive analysis of the FDA’s regulatory requirements — and more importantly, strategies for complying and reducing risk while saving time and money.

Is your organization at risk of FDA 483s and Warning Letters?
Don’t incur excessive costs and delays. Equipment Maintenance, Calibration and Cleaning: A Guide to FDA Inspections is a clear, concise guide. Get it now and learn:

  • How the FDA identifies weaknesses in cleaning, maintenance and calibration programs
  • What it wants to see in data trending
  • Common pitfalls that cause FDA red flags
  • Special considerations to be aware of when using outsourced providers
  • Advantages and dangers of PM grace periods
  • FDA expectations concerning frequency schedules; defined procedures and methods; documentation or results; and evaluation of deviations on equipment or products
  • How to conduct internal audits
  • Answers to the most frequently asked questions

Ideal for Drug and Device Makers
The report provides the right information in an easy-to-use package for engineering and environmental control teams, manufacturing directors and supervisors, GMP auditors, risk management specialists, training personnel, validation specialists, scientists and engineers, QA/QC personnel, compliance officers, those new to the industry, and consultants and service providers.

Remember: Requirements to Maintain Equipment are Not Self-Evident – It’s the Details
Violations are often not the result of lax calibration, maintenance and cleaning.

Rather, they result from an inability to satisfy the detailed requirements of maintaining a defensible maintenance, calibration and cleaning schedule.

In addition to explaining regulatory requirements, this report tells you how to avoid issues associated with frequencies as well as operational limits — and what to expect in the future.

Information You Need From an Expert You Can Trust
This special report is based on a January 2013 FDAnews webinar featuring Kenneth Christie, Chief Operating Officer of Consulting Services at VTS Consultants, Inc. Christie has more than 25 years’ experience in manufacturing of sterile products, quality assurance and validation management. He spent 13 years with the Parke-Davis Sterile Products Division of Warner-Lambert, where he served as manager of the validation department. He also managed contracted validation personnel and defended all corporate validation practices with regulatory agencies such as CBER, CDER and the United Kingdom’s MHRA Division. In addition, he spent seven years working for Wyeth Laboratories’ Sterile Biological Vaccines Division of American Home Products as a manufacturing supervisor.

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Table of Contents

  • Maintenance and Cleaning Regulation and Problem Areas
  • Calibration Regulation and Problem Areas
  • Putting the Pieces Together for Compliance
  • Special Considerations for Contract Services and Vendors

View the entire TOC

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