Master the GMP release systems, chain-of-identity controls, and traceability frameworks required to protect patient safety and maintain regulatory compliance in advanced therapy manufacturing.
Includes live access & recording
Advanced therapies have created a manufacturing environment where product quality, patient safety, traceability, and operational execution are inseparably linked. Unlike traditional manufacturing models, advanced therapy operations frequently involve patient-specific starting materials, individualized manufacturing processes, multiple external partners, complex logistics networks, and compressed timelines that demand extraordinary levels of process control.
This webinar examines the critical GMP systems required to maintain chain-of-identity and support compliant product release within advanced therapy manufacturing environments. Participants will explore how patient-specific materials are controlled throughout collection, transportation, manufacturing, testing, storage, shipment, and administration activities.
The session addresses common operational failure points that can compromise traceability and examines approaches for reducing risk through system design, procedural controls, training, and oversight mechanisms — including GMP release considerations unique to advanced therapies such as conditional release decisions, rapid testing strategies, deviation handling, and quality oversight of outsourced activities.
Advanced therapies introduce quality and operational challenges unlike those encountered in traditional pharmaceutical manufacturing. In many cases, there is no opportunity to replace a batch, repeat a manufacturing campaign, or recover from a significant process error. The product may represent a single patient's treatment opportunity.
Regulators continue to increase their scrutiny of chain-of-identity, chain-of-custody, traceability, release processes, data integrity controls, and supplier oversight. Many organizations struggle with integrating traditional GMP systems into advanced therapy workflows — and these challenges become even more significant as organizations move from clinical production into commercial manufacturing.
This webinar provides practical guidance for establishing robust chain-of-identity systems, managing GMP release activities, implementing traceability controls, and reducing operational risk within advanced therapy manufacturing.
By the end of this session, participants will have practical strategies for establishing chain-of-identity controls, managing GMP release, and building traceability systems for advanced therapy operations.
Understand the GMP systems required to maintain chain-of-identity across the full advanced therapy lifecycle.
Implement patient-specific material tracking from collection through final administration across multiple partners.
Design chain-of-identity systems that encompass workflow design, electronic tracking, and material handling procedures.
Manage GMP release decisions unique to advanced therapies — including conditional release, rapid testing, and deviation handling.
Identify and address common operational failure points that compromise traceability and patient safety.
Understand regulatory expectations from FDA, EMA, and global health authorities for ATMP traceability and release.
Apply data integrity controls specific to patient-specific product environments and outsourced testing activities.
Build quality systems scalable from clinical to commercial advanced therapy manufacturing operations.
Four critical focus areas covering chain-of-identity, release governance, regulatory alignment, and operational scalability in advanced therapy manufacturing.
Learn how chain-of-identity systems extend beyond labeling into workflow design, electronic tracking, material handling, supplier management, transportation controls, and release governance.
Understand the release considerations unique to advanced therapies — conditional release, rapid testing strategies, comparability assessments, product disposition, and deviation management within personalized manufacturing environments.
Get clarity on what FDA, EMA, and global health authorities expect regarding traceability, chain-of-custody documentation, quality agreements, data integrity, and supplier oversight for ATMPs.
Examine the real-world operational challenges of scaling advanced therapy programs from clinical manufacturing to commercial production — and how to build systems capable of supporting that growth.
Twenty topics covering the complete operational and regulatory landscape of advanced therapy GMP release and chain-of-identity controls.
Quality, manufacturing, regulatory, and operations professionals in cell therapy, gene therapy, tissue engineering, personalized medicine, and related advanced therapy organizations.
Quality Assurance Directors
Quality Systems Managers
GMP Compliance Professionals
Cell Therapy Manufacturing Managers
Gene Therapy Manufacturing Managers
ATMP Program Leaders
Qualified Persons (QPs)
Regulatory Affairs Professionals
Validation Managers
Manufacturing Directors
Operations Directors
Technical Services Personnel
Supply Chain Managers
Logistics Coordinators
Clinical Manufacturing Personnel
Quality Control Managers
Deviation Investigators
Data Integrity Professionals
Supplier Quality Managers
Advanced Therapy Consultants
Advanced therapy medicinal products (ATMPs), including cell therapies, gene therapies, tissue-engineered products, and personalized medicines, have fundamentally changed the traditional manufacturing and quality paradigm. Unlike conventional pharmaceutical products produced in large batches for broad patient populations, many advanced therapies are manufactured for specific individuals, often involving complex collection, processing, testing, release, and administration activities that must be precisely coordinated across multiple organizations and locations.
In these environments, maintaining chain-of-identity and chain-of-custody controls becomes as critical as the manufacturing process itself. A single breakdown in patient identification, material tracking, labeling, documentation, transportation, or release decision-making can create significant patient safety, product quality, regulatory, and business risks. Regulatory agencies worldwide have increasingly focused on the controls organizations use to ensure that the right product reaches the right patient at the right time while maintaining complete traceability throughout the product lifecycle.
The operational challenges are substantial. Organizations must manage complex logistics, compressed manufacturing timelines, limited material availability, multiple handoffs, outsourced testing, evolving technologies, and highly individualized production processes. Traditional GMP systems often require significant modification to support these unique operational realities — and these challenges intensify as programs transition from clinical to commercial scale.
This webinar examines the GMP release requirements, chain-of-identity controls, traceability systems, and operational practices necessary to support advanced therapy manufacturing and patient delivery. Participants will gain practical insight into building systems that maintain product integrity, patient safety, regulatory compliance, and operational reliability across increasingly complex advanced therapy supply chains.
Charles H. Paul is President of CHP Consulting LLC, a regulatory compliance, operational excellence, training, and technical documentation consulting firm supporting pharmaceutical, biotechnology, medical device, and advanced therapy organizations worldwide. With more than 30 years of experience in regulated manufacturing environments, Charles specializes in helping organizations build sustainable quality systems that support compliance, operational performance, workforce effectiveness, and inspection readiness.
His experience includes GMP quality systems, manufacturing operations, technical training development, process validation, deviation management, CAPA systems, operational excellence, documentation systems, and regulatory inspection preparation. Charles has supported organizations implementing new technologies, expanding manufacturing operations, establishing quality infrastructures, and preparing for complex regulatory inspections.
Charles is a recognized author, speaker, and consultant who has delivered numerous webinars and seminars on GMP compliance, quality systems, human performance improvement, technical documentation, inspection readiness, and operational excellence throughout the life sciences industry.
Don't miss this essential training on advanced therapy GMP release and chain-of-identity controls. Build the systems needed to protect patients and meet regulatory expectations.