Ithos Ingredient SAFE
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This brief .PDF explains a bit more about our Ingredient SAFE solution, and how it was applied to Golden State Foods - one of the largest diversified suppliers to the foodservice industry, servicing more than 20,000 restaurants from three continents.
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The document outlines Darden's global food safety strategy, which focuses on inspecting food production at the source to ensure safety throughout the entire supply chain. The key aspects of the strategy include implementing Hazard Analysis and Critical Control Point processes, verifying that suppliers meet food safety standards, conducting inspections and testing at production sites before products are shipped, and emphasizing traceability from raw materials to finished products. The overall goal is to develop an integrated system of growers, processors and distributors that meets the highest standards for food safety, quality, and service.
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Data Integrity Concepts based on the GMP regulations for the pharmaceutical industry
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Clearstream Solutions is a leading supply chain and sustainability services provider. They help organizations implement sustainable practices and manage third party risk and GDPR compliance. Their clients include Microsoft, Symantec, and Honeywell. Clearstream provides tools and consultancy services to assess supplier GDPR readiness and implement responsible sourcing programs. They discuss how the GDPR increases obligations for protecting data and introduces significant penalties for non-compliance. Clearstream's platform allows suppliers to report information and buyers to monitor compliance.
National Honey Packers and Dealers Association
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Quality & compliance excellence in pharmaceuticals
Quality can be defined in several ways including conformance to specifications, fitness for use, and value for price paid. It is judged based on factors like performance, reliability, and support services provided. Pharmaceutical products have higher quality standards and more regulations compared to consumer goods due to their intended use and potential risks. Ensuring compliance with various quality guidelines is important for patient safety and involves establishing quality systems, policies, procedures, documentation, and ongoing assessments like audits and corrective actions. Non-compliance can result in issues like complaints, recalls, and regulatory actions.
Vendor Management - Compliance Checklist Manifesto Series
Regulatory examiners are expecting to see and review your financial institution's vendor management program, which is to include a process for assessing specific vendor risk, vendor selection, contracting, and ongoing oversight. This webinar will demonstrate that implementing a repeatable process will provide consistency and reduce your institution's Compliance Tax by saving you time and resources, including helping to ensure your valuable dollars are spent wisely.
Objectives:
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Computer Software Assurance (CSA): Understanding the FDA’s New Draft Guidance
Understand the FDA's new draft guidance on Computer Software Assurance (CSA).
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
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This document summarizes a presentation about using clinical intelligence to address persistent key risk indicators (KRIs) in clinical trials. It discusses how clinical intelligence can help identify, triage, analyze, and validate KRIs like protocol deviations in real-time. This allows clinical teams to proactively manage issues, focus on high risks, and continuously monitor trials to reduce operational and regulatory risks and keep trials on schedule. The presentation provides examples of how clinical intelligence can provide alerts for deviations, composite risk scores to prioritize issues, granular analyses at the study, site and category levels, and audit trails to validate corrective actions are taken.
Freyr Pharmacolvigilance Brochure
Freyr provides pharmacovigilance solutions and services including case management, medical review, safety reporting, literature screening, and signal detection. They offer end-to-end pharmacovigilance processes from data collection through reporting to regulatory authorities. Freyr prides itself on quality, reliability, and regulatory compliance with over 99% adherence to deadlines and improved accuracy rates through lean processes.
Navigating the Perfect Storm of Supplier Constraints
Dr. Liliana Casal-Wardle presented on navigating supply chain constraints. She discussed the increasing complexity of global supply chains and challenges presented by the COVID-19 pandemic, natural disasters, and changes in the workforce and transportation. She emphasized the importance of supplier approval programs, monitoring supplier performance, and being prepared for emergency sourcing situations. Dr. Casal-Wardle also provided tools for managing supply chain risks, such as databases for ingredient sourcing and tracking supplier audit results, recalls, and complaints. She stressed the critical role of food safety culture and continuous improvement programs across the supply chain.
Synchrogenix Inc Capabilities Presentation Jan 2010 Final
Synchrogenix is a large regulatory and medical writing company with 23 years of experience supporting pharmaceutical and biotech companies globally. It has locations in North America, Europe, and Asia Pacific. Synchrogenix offers full outsourcing capabilities for regulatory submissions, medical writing, and other documentation needed for drug approval and commercialization. It employs permanent staff writers with therapeutic expertise across many areas.
Analysis of raw materials
This file describes analysis of raw material in pharmaceutical and contain different steps which is to be followed for its analysis
Similar to Ithos Ingredient SAFE (20)
Managing Regulatory Compliance and Food safety With Cloud Data Supervision-Ch...
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Introduction-to-Food-Traceability-Software ppt.pdf
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Synchrogenix Inc Capabilities Presentation Jan 2010 Final
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留信网认证的作用:
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Ithos Ingredient SAFE
- 1. Ingredient SAFE Better Supplier Quality and Risk Management Practices start with managing the deepest level of Product and Supplier data. Ingredient & Supplier Traceability International Compliance Suppliers may fail to disclose the key details Track ingredients to the exact plant location surrounding their ingredients (e.g. allergen at which they were distributed contamination, usage levels, regulatory re- Easily manage supplier quality and ingredi- strictions, etc.) ent traceability by using our advanced Filter Regulatory assessments and supplier data are Tools separated from your current quality manage- Reporting Tools facilitate fluid supplier qual- ment solution ity assessments Managing supplier quality offers more Store and maintain supplier contact infor- “unknown” risks, as more processors begin mation for accurate and timely communica- sourcing ingredients from foreign suppliers tions Recent Client Engagement with Golden State Foods Let Ithos Solutions... Collect and store detailed Ingredient, Regulatory, and Supplier documentation (e.g. MSDS, Country of Origin, Allergen Statements, Certificate of Analysis, Certificate of Conformance, 3rd Party Audits, etc.) Secure this information in a centralized location Provide Total access to this software at the company-wide level Contact Monica.Dema@IthosGlobal.com for more information.