This training program will discuss the new blockchain innovations particularly as they can be used to connect and protect the regulated supply chain. The focus will be on how this can enhance cMGP compliance while it strengthens a company’s critical supply chain. This webinar will explore the growing use of blockchain in supply chain control. Basically, blockchain is a time-stamped series of records of data that is managed by a distributed, networked cluster of computers under multiple ownership. Under blockchain, individual blocks of data is secured and bound/ “chained” to each other under cryptographic principles. First used for Bitcoin, it has since expanded into mainstream business use, with it’s most immediate use to date in supply chain management. Major names in the industry, such as IBM, offer the technology. With no central authority in the blockchain network, it basically presents a shared ledger. Data is open for anyone to see – transparent. It makes everyone involved is accountable for their actions, which are limited, recorded, and available for review and/or further action. Why You Should Attend: Blockchain implementation require planning, verification, testing, validation, traceability, configuration management, conformance to software V&V including 21 CFR Part 11 – electronic records and electronic signatures, and other aspects of good engineering. These assure they meet existing CGMP regulations. The cGMPs and FDA requires the integration of life cycle and risk management activities into the planning, implementation, and maintenance of a blockchain facilitated supply chain. Learning Objectives: What is “blockchain”? Basic building blocks of blockchain Blockchain and the supply chain Blockchain and pedigrees Blockchain and counterfeit product Current state of blockchain in FDA regulations / the cGMPS Key areas of the cGMPs – Device and Drugs – impacted by blockchain Implementation in the supply chain US FDA compliance inspection objectives in supply chain blockchain implementation Further potential Understanding the challenges Areas Covered in the Session : What do the cGMPs require? Intent of 21 CFR Part 210, 211, and 820 as they affect blockchain in the supply chain Key FDA Regulatory concerns Responsibilities Key Definitions Working Definitions Risk Management / Assessment Quality Agreements Challenges Who Should Attend: Quality Assurance Departments Quality Control Departments Research and Development Departments Regulatory Affairs Departments Compliance Departments Manufacturing Departments Engineering Departments Operations Departments Production Departments Purchasing Departments Inventory Control / Management Process Development Engineers Software Engineers


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Areas Covered in the Session :

  • Review the current regulatory requirements and guidances (CFR, EU GMPs, ISO, etc.) for environmental monitoring.
  • Discuss issues of sampling methods, selection of sampling sites and the justifications for them.
  • Review the issue of contamination control as an important aspect of EM programs.
  • Discuss the issue of action and alert limits, trending of data and the handling of excursions.
  • What are the most common deficiencies cited by regulatory auditors when auditing environmental monitoring programs?
  • Attendee question and answer period.

Who Should Attend:

  • QA/QC Teams
  • Manufacturing Teams
  • Engineering Teams
  • Validation Teams
  • Regulatory affairs Teams
  • Management Teams
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