Blockchain Innovations that Connect and Protect the Supply Chain

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

FDB3186

John E. Lincoln

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.

He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.

membership
  Go PRIME   🛈 $ 240 SELECT
  Personal Plan 🛈 $ 3000 SELECT
  Business Plan 🛈 $ 9000 SELECT


  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance