LIVE WEBINAR

Advanced Therapy GMP Release and Chain-of-Identity Controls

ABOUT THE COURSE

Advanced therapies have created a manufacturing environment where product quality, patient safety, traceability, and operational execution are inseparably linked. This webinar examines the critical GMP systems required to maintain chain-of-identity and support compliant product release within advanced therapy manufacturing environments.

The session follows the movement of patient-specific materials through collection, manufacturing, testing, release, shipment, and administration while connecting operational controls, documentation practices, supplier oversight, traceability systems, and regulatory expectations into a single quality management perspective.

Designed for organizations responsible for patient-specific manufacturing, traceability systems, GMP release activities, outsourced operations, and quality oversight across advanced therapies.

KEY AREAS COVERED

Chain-of-identity and chain-of-custody control principles
Patient-specific material tracking and identification systems
Electronic traceability and data integrity practices
GMP release governance and conditional release decisions
Transportation, supplier, and outsourced activity oversight
Deviation management and change control in personalized manufacturing
Scaling traceability from clinical to commercial operations

Course Director

Charles H. Paul

Charles H. Paul has more than 30 years of experience supporting regulated manufacturing operations, quality systems, inspection readiness, and operational excellence across pharmaceutical, biotechnology, medical device, and advanced therapy organizations. His practical experience with GMP operations, quality infrastructure, and manufacturing execution provides direct insight into the traceability and release challenges unique to patient-specific therapies.

FDB1607

◙

🏠︎