Making a Mole Hill Out of a Mountain: An Example of Cleaning Validation Remediation During Commercial Operations Under Consent Decree
At INTERPHEX, Jeff Gerstein presents a real world look at the planning, execution, and lessons learned associated with the cleaning program remediation of a commercial manufacturing facility while operating under a consent decree. Discussions will include cleaning procedural changes, associated validation requirements, and the logistics of cleaning verification to support parallel manufacturing. Focus areas such a planning, resources, execution, and impacts to critical lot dispensation will be reviewed with emphasis on developing tools for future use. Additionally, the presentation will touch on project reactions to extrinsic critical failures and how planning provided risk mitigation.
Add Jeff's session to your plan on the INTERPHEX website.