Packaging or equipment that come into contact with food may be subject to FDA regulation if their chemical components are deemed by FDA to be “indirect food additives,” also known as “Food Contact Substances.”The determination of how a particular food contact substance is regulated by FDA depends on its chemical composition and intended uses. Registrar Corp’s team of Regulatory Specialists help manufacturers identify the specifications and limitations published and enforced by FDA concerning their specific products. • OFAS(Office of Food Additive Safety ) ensures that the food contact substance is safe. • Food manufacturers should submit the (Food Contact Notification)FCN to OFAS 120 days prior.
· SAR(Structure Activity Relationship) checks the relationship between compound’s chemical structure and the physiochemical properties and its biological effect.
• QSAR software program can be used and this is effective than the genetic toxicity methods.
• To ensure appropriate information is submitted for a Food Contact Substance Notification, FDAhas provided access to electronic form.
• FCN can be securely submitted through Electronic Submission Gateway (ESG) using CFSAN Online Submission Module (COSM).
• For individual substance that is reasonably expected to migrate to food because of its intended use in food contact material should have FSC notification.
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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.