Making a Mole Hill Out of a Mountain: An Example of Cleaning Validation Remediation During Commercial Operations Under Consent Decree
Watch Jeff Gerstein's INTERPHEX Live presentation as he illustrates the process of planning, executing, and learning from the cleaning program remediation of a commercial manufacturing facility while operating under a consent decree. The discussion will cover cleaning procedures, validation requirements, and logistics associated with cleaning verification for parallel manufacturing. Focus areas such as planning, resources, execution, and impacts to critical lot dispensation will be reviewed with emphasis on developing tools for future use. Moreover, the presentation will cover project reactions to extrinsic critical failures and how planning provides risk mitigation.