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As the regulations for food and pharma' get closer together in nature an overarching guidance is emerging which is related to risk aversion and risk mitigation planning.

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Peter Norton is currently employed as the Business Development Director for DeltaTrak Inc., of Pleasanton CA. His primary areas of expertise relate to Cold Chain and Supply Chain Logistics Solutions, for which he advises clients on processes related to Cold Chain shipping solutions, Risk Assessment, Inventory Management and the emerging new rules and regulations for Cold Chain linked into Track and Trace and e-Pedigree.

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I guess by now the rumors are true and the FDA has recently (late 2015) announced that it will begin much more stringent inspections for compliance to 21 CFR Part 11 regulations related to and concerning electronic records, audit trails concerning metadata, and signatures that need to be actual and trustworthy, plus validation of products.

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Peter Norton is currently employed as the Business Development Director for DeltaTrak Inc., of Pleasanton CA. His primary areas of expertise relate to Cold Chain and Supply Chain Logistics Solutions, for which he advises clients on processes related to Cold Chain shipping solutions, Risk Assessment, Inventory Management and the emerging new rules and regulations for Cold Chain linked into Track and Trace and e-Pedigree.

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The ICH and other globally focused organizations are working diligently to introduce more consolidated forms of quality regulations, like the ICH Q10, for the management of the quality of drugs related to cold chain distribution and drug security.

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Peter Norton is currently employed as the Business Development Director for DeltaTrak Inc., of Pleasanton CA. His primary areas of expertise relate to Cold Chain and Supply Chain Logistics Solutions, for which he advises clients on processes related to Cold Chain shipping solutions, Risk Assessment, Inventory Management and the emerging new rules and regulations for Cold Chain linked into Track and Trace and e-Pedigree.

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When any QA department turns their attention to data and security most of the focus is on how this is controlled internally in relation to common regulations like - 21 CFR Part11, Part 820, GMP, etc., and of course patient data regulations like HIPAA.

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Peter Norton is currently employed as the Business Development Director for DeltaTrak Inc., of Pleasanton CA. His primary areas of expertise relate to Cold Chain and Supply Chain Logistics Solutions, for which he advises clients on processes related to Cold Chain shipping solutions, Risk Assessment, Inventory Management and the emerging new rules and regulations for Cold Chain linked into Track and Trace and e-Pedigree.

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In March of 2013 in the EU the EMA introduced a new guideline related to Good Distribution Practices (GDP) and in June of 2013 the Chinese FDA introduced a new guideline related to Good Supply Practices (GSP).

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Peter Norton is currently employed as the Business Development Director for DeltaTrak Inc., of Pleasanton CA. His primary areas of expertise relate to Cold Chain and Supply Chain Logistics Solutions, for which he advises clients on processes related to Cold Chain shipping solutions, Risk Assessment, Inventory Management and the emerging new rules and regulations for Cold Chain linked into Track and Trace and e-Pedigree.

Peter's Recent Articles