Description

A need for process equipment to be visually clean at the end of a validated cleaning process has been a requirement from the beginning of regulatory guidances for cleaning validation. The idea of using a visually clean assessment as possibly being a more stringent criterion than a calculated carryover calculation was introduced in the late 1990s by the PIC/S. As a result, there were many publications in the early 2000s dealing with visual residue limits. Recently the EMA has presented the option of using visual residue limits (URLs) as part of routine monitoring. This live webinar will cover defining a VRL, designing studies to determine a VRL, and using URLs in a meaningful way in qualification protocols and routine monitoring.

Learning Objectives:-

• Understand the meaning of visually clean
• Learn parameters of visual assessment
• Understand the relationship between URLs and calculated carryover limits
• Learn how to determine a VRL in a lab study
• Explore when URLs are required (and when they are not)
• Learn how and when to use VRLs for routine monitoring

Webinar outline:-

• Introduction
• Meaning of “Visually Clean”,
• Parameters for visual assessment,
• Different uses of a visually clean criterion,
• Definition of “Visual Residue Limit”,
• How to determine a VRL in the lab,

Break

• How to determine a VRL in the lab (continued),
• Comparing a VRL to a carryover calculation limit,
• Practical options for VRL determination,
• Use of VRLs in routine monitoring per EMA’s Q&A,
• Live Questions & Discussion

Who should attend:-
This live training webinar applies to drug product manufacturers and API manufacturers, including biopharmaceutical manufacturers. The following individuals or disciplines involved in process equipment cleaning validation will benefit from attending this live webinar:

• Microbiology personnel
• Senior management responsible for cleaning validation
• Validation, Quality Control, Quality Assurance, Manufacturing, Regulatory Affairs, Technical Support
• Directors, Managers/Supervisors, Scientists, Technicians, Operators, Auditors
• Regulatory Affairs Professionals