Design/development and validation maintenance has always been part of what pharmaceutical companies do for cleaning validation. Now there is an increasing trend to make a lifecycle approach part of a formal cleaning validation program. This has been accelerated by the publication of the 2011 FDA Process Validation guidance, as well as documents from other regulatory agencies and from ICH. While the FDA guidance does not formally apply to the validation of cleaning processes, other regulatory documents include cleaning processes within the purview of a lifecycle approach.

This live webinar is designed to provide an introductory review of the lifecycle principles in various regulatory documents, focusing on the FDA Process Validation Guidance. It then discusses how the principles of lifecycle validation might be applied in a cleaning validation program. It will also cover some principles typically applied in a process validation program that might not apply to a cleaning validation program. Furthermore, strategies for simplifying cleaning validation based on lifecycle principles will also be covered, including strategies to streamline cleaning validation programs based on good science and appropriate risk assessments. This includes the possibility of reducing the number of validation runs required and of moving “worst case” evaluations to the design/development phase. Application of these lifecycle principles will help provide robust and meaningful strategies for designing and improving cleaning validation programs.

Learning Benefits:

• Clarify what dedication means.
• Explore options for validating dedicated equipment.
• Clarify the nature of campaigns.
• Learn how to deal with “minor” cleaning within a campaign.
• Explore options for campaign length.
• Learn how regulatory documents address these issues.

Who should attend:

This live training webinar is applicable 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:

• Directors, Managers, Supervisors, Scientists, Technicians
• Quality Control, Quality Assurance, Manufacturing, Regulatory Affairs Personnel
• Technical Support
• Senior Management responsible for cleaning validation
• Validation