FDAnews Management Report: Equipment Maintenance, Calibration and Cleaning

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Problems with equipment maintenance, cleaning and calibration are among the FDA’s most commonly observed deficiencies. This timely management report from FDAnews will help avoid these issues and reduce risk.

Equipment Maintenance, Calibration and Cleaning
A Guide to FDA Inspections
**FDAnews Management 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 an 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 explains how to avoid issues associated with frequencies as well as operational limits — and what to expect in the future.

Equipment Maintenance, Calibration and Cleaning
A Guide to FDA Inspections
**FDAnews Management Report**

FORMAT: Print or PDF
PRICE: $397

Online:     http://www.fdanews.com/EquipmentMaintenance
By phone: 888-838-5578 or 703-538-7600

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
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