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Cleaning Validation has traditionally focused on the direct product surfaces of manufacturing equipment. Setting limits and dealing with these surfaces in cleaning validation is relatively straightforward. However, there have been increasing regulatory and industry concerns about indirect product contact surfaces (defined as a non-product contact surface that is in close proximity to open product where there is a reasonable probability of transfer of residues from that surface to the product). A newer concern, particularly for highly hazardous products, is related to residues on non-product contact surfaces.
This webinar will focus on these two situations, exploring risks and dealing with these surfaces from a cleaning validation perspective.
-Understand the differences among different types of surfaces.
-Explore how residues might transfer from these surfaces to manufactured product.
-Learn options for setting limits in each case.
-Learn data collection to support risk assessments.
-Explore differing ways to address highly hazardous and non-highly hazardous actives.
-Explore options to consider going forward.
Who should attend:
This 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:
• 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
Dr. Michael C. Redmond, PhD, is a certified project manager, PMP, has two master certifications in business continuity/disaster recovery MBCP and FBCI and is certified in emergency management. She is active in cyber security and holds multiple ISO certifications (ISO/IEC 27001 Information Security Management, ISO/IEC 27032 Lead Cyber Security Manger, ISO/IEC 27035 Security Incident Response, ISO/IEC 22301 Business Continuity Management Systems, ISO/IEC 21500 Project Management, and ISO/IEC 41001 Environmental Management). She is an international consultant, speaker and published author.
Michael's MBA in Risk Management included courses in Information Security and Risk Management for Medical Devices and Healthcare. Michael is certified as a Senior Lead Manager in Information Security for Healthcare ISO 27999.As a practitioner, she has been implementing ISO 27999 and ISO 14971 for over 10 years for clients.
Her past experience includes 13 years as a senior manager with Deloitte, KPMG and Chubb in the areas of: compliance, crisis management, business continuity, disaster recovery, emergency management, internal audit/ gap analysis. She was a business continuity/disaster recovery manager with the Bank of New York. She consults for clients in diverse industries such as banking, manufacturing, pharmaceutical, hospitals, government agencies, colleges and universities, law firms, and media.
Dr. Redmond spent 4 years on active duty with the army and 18 1/2 years as National Guard and Reserve before retiring as a major. She is a graduate of Command & General Staff College (Fort Leavenworth), attended civil affairs courses at the US Army JFK School of Special Warfare and is Hazmat trained and DOD certified. The White House honored Dr. Redmond at a luncheon as one of the Top Women in Her Field of Business Continuity.