About the Course:

Control of cross-contamination is a major compliance issue in our industry today. Central to any effective strategy for control is the demonstration that our cleaning procedures are robust and capable of consistently removing residual products down to levels which do not pose a risk to patient safety.

Validation of cleaning procedures is thus critical to any Quality Assurance program and is currently a topic of great concern to regulators worldwide.

This course has been designed to provide practical advice on how to design and execute cleaning validation studies to meet current regulatory expectations in a cost-effective way.

General principles of cleaning validation will be supplemented by specific case studies from industry specialists from

Dosage form manufacture and packing
Active pharmaceutical ingredient manufacturing
Biotech manufacturing
The special challenges of clinical trials manufacturing and packing will also be discussed.