The FDA citations related to cleaning validation have skyrocketed since the inspections began in full swing earlier in 2022.
The evolution of the regulatory expectations has created a clear gap between the complex requirements and the site procedures. Hence the QA leadership urgently needs to ensure that their cleaning validation procedures and the SMEs are audit-ready.
Event details:
- Technical experts: Igor Gorsky (Principal Process Validation Consultant, Valsource) and Thomas Altmann (Global Techincal Manager Ecolab)
- When: 4th & 5th August 2022
- Where: Radisson Blu Mumbai International Airport
Agenda:
- Overview of the latest requirements & upcoming standards
- Optimizing cleaning procedures - manual & automated
- Use of Statistics and Censored Data in Cleaning Validation
- Learnings from implementing CLEEN software at hundreds of sites
- Top 7 gaps in the Cleaning Validation audit-readiness and how to fix them
- ...and many more topics