Blockchain Innovations that Connect and Protect the Supply Chain

Recorded Webinar | John E Lincoln | From: Mar 17, 2021 - To: Dec 31, 2021

Training Options & Pricing

Error Conference Exists In Wish-list.

Congrats Conference Added In Wish-list.

Recording
⊖   ⊕$229  
DVD
⊖   ⊕$249  
Recording + DVD
⊖   ⊕$389  
Transcript (Pdf)
⊖   ⊕$229  
Recording & Transcript (Pdf)
⊖   ⊕$379  
DVD & Transcript (Pdf)
⊖   ⊕$389  


Order Form

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 cGMP 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 are secured and bound/ “chained” to each other under cryptographic principles. First used for Bitcoin, it has since expanded into mainstream business use, with its 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.

Learning Objectives:-

  • What is “blockchain”?
  • Basic building blocks of blockchain
  • Blockchain and the supply chain
  • Blockchain and pedigrees
  • Blockchain and counterfeit product
  • The 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?
  • The 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

Why You Should Attend:-

Blockchain implementation requires 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.

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

John E Lincoln

John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.