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, a 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 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 accountable for their actions, which are limited, recorded, and available for review and/or further action.
Why Should You 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.
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
Webinar Takeaway
- 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
Speakers
John E. Lincoln,
Principal Consultant ,
J. E. Lincoln and Associates LLCJohn E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company, with over 33 years’ experience in U.S. FDA-regulated industries and 20 years as a full-time consultant. He 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 including QMS and so+E6ftware validations, ISO 14971 product risk management files / reports, design control / design history files, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CGMP subjects. He is a graduate of UCLA.
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
