Target Audience:

Technologists, Clinical Laboratory  Scientists, Regulatory and Quality Assurance Personnel involved in the manufacture of cellular therapy products used for transplantation as well as other novel therapeutic modalities. Topics will focus on practical laboratory techniques, and quality assurance practices performed on a daily basis by cellular therapy processing laboratories that insure operations meet accreditation guidelines and regulations. The Technical Track is pleased to offer a variety of presentation formats, including Technical Breakfasts, Workshops and Round Table discussions in order to facilitate interactive participation by attendees.

This continuing medical laboratory education activity is recognized by the American Society for Clinical Pathology as meeting the criteria for 20.25 hours of CMLE credit.  ASCP CMLE credit hours are acceptable to meet the continuing education requirement for the ASCP Board of Registry Certification Maintenance Program.  California CMLE credits are also available for 20.25 hours.

Objectives:

1. Describe tools, requirements and approaches used to develop a comprehensive Quality Management Program
2. Address key technical and quality issues in the processing, storage, thawing and infusion of cellular therapy products.
3. Evaluate a variety of real life situations and scenarios including topics such as adverse reactions, disaster planning and staffing, determine appropriate response, and appraise outcome.
4. Review regulatory and accreditation requirements for biological products used in cellular therapy and provide an opportunity for audience exchange with representatives of these agencies.
5. Provide a platform for cellular therapy quality assurance and laboratory personnel to network with fellow colleagues and interact with experts in the field.

Session Titles Include:

• Adverse Reactions in CT Products
• Quality Plans: Development and Implementation
• Deviation Management: From Discovery to Reporting
• Ask the Experts
• Agreements and Contracts
• Issues in Staffing CT Programs
• ISBT 128 for CT Products
• Cellular Products Processing and Thawing Techniques
• Product Quality Characterization: Release Criteria, Post Thaw Assessment, and Stability Testing
• Disaster Planning: Are YOU ready?
• Validation, Verification and Qualification: What to do When?