While not explicitly stated in the US Food and Drug Administration guidelines, cleaning validation is a clear requirement to maintain compliant with global regulations.
During a presentation on good cleaning practices at IVT's 17th Annual Validation Week, Dawn Tavalsky discussed how to remain compliant after cleaning validation is complete. Tavalsky explains preventative maintenance and provides a real-world failure example. Tavalsky also illustrates cleaning validation monitoring, including what it is, monitoring cleaning processes and cycles, and trends.
Thorough and frequent handwashing is becoming increasingly important in business and personal applications. Handwashing training with visual testing is an effective method to improve performance. Key points in hand washing techniques and visual testing are demonstrated by Paul L. Pluta, Ph.D, at IVT's Cleaning Validation and Critical Cleaning Processes conference.
At IVT's 17th Annual Validation Week, Dawn Tavalsky gives a must-see presentation for any organization looking to implement or reimplement a cleaning validation program from scratch. At the beginning of the presentation, Tavalsky discusses the definition of cleaning validation; the FDA, Health Canada, and European regulatory expectation for cleaning validation; and the realistic scope of a...
The following key points are discussed in this case study:
A validation case study involving equipment cleaning and inspection of cleaned equipment is discussed
The event comprised of cleaning multiple equipment per procedure. Manufacturing residue was observed in only one specific piece of equipment after cleaning
The following three issues were investigated: