The FDA is cracking down hard on drug and device manufacturers for violating their cleaning validation processes and protocols.

For example, in a recent warning letter, one company received five paragraphs of cleaning validation violations — from failure to have cleaning validation studies to a lack of documentation describing the preparation of the cleaning/sanitizing agent.

But you don’t have to fear Form 483s, warning letters, lawsuits, recalls or bad publicity — if you have front-line strategies in place for implementing an effective and compliant cleaning validation program.  Maintaining or cleaning equipment at appropriate intervals or lack of indication of final rinse verification may seem like small issues on the surface but can easily lead to serious cleaning validation violations. Do you know the best strategies you can implement to avoid these — and other — disasters through every step of the process? 

Make sure your procedures and documentation are up to snuff. An all-new management report from FDAnews is your step-by-step guide.

Cleaning Validation: Strategies for Compliance

Cleaning Validation: Strategies for Compliance goes beyond the regulations and digs into the real-life world of cleaning validation. Tips to create an effective master plan ... appropriate SOPs ... auditing for compliance ... practical solutions to troublesome cleaning validation challenges ... this timely volume help keep the FDA at bay, boost production efficiency, and fatten your bottom line.

You’ll learn:

• 3 steps to take even before commencing cleaning validation
• Best analytical methods and sampling to determine cleanliness
• 5 most important components of a cleaning validation master plan
• Documentation and SOPs needed for cleaning agents and testing equipment
• Special cases — how to validate cleanliness of non-standard equipment and utensils
• And more!

Wait for your next GMP inspection and you’ve waited too long. Get your copy today.

Chapter List

• Approaches to cleaning validation
• Developing cleaning SOPs and management tools
• Cleaning validation master plan
• Review of FDA inspection comments, objections
• And much more!

Buy Now!
This first-ever Cleaning Validation: Strategies for Compliance management report is expected to sell out quickly. Future editions and updates may be priced higher. That’s why it’s a good idea to order your copy today. Cleaning Validation: Strategies for Compliance is available for $377 in print and PDF format.

Satisfaction Guaranteed
Your risk is zero when you purchase under our money-back guarantee. Not satisfied with the management report? Return the hard copy within 30 days (in reasonable condition) for a 100 percent refund of your purchase price (less shipping/handling). For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase to receive a refund.