Tuesday, September 16
5:15-5:45 Dinner Short Course Registration
Dinner Short Course Description
This course provides the comprehensive background information, requirements and guidelines necessary to successfully run biobanks while also serving clients. To translate research needs to a high-functioning lab program that produces high-quality biomaterial and data deliverables, detailed upfront planning, efficient processes, cutting-edge science and technology plus an understanding of program management are critical. Such elements affecting strategic and day-to-day responsibilities, as well as fundamentals like staying within time, cost, scope and quality constraints while meeting customer needs; maintaining proper documentation, from Standard Operating Procedures to training records, in a controlled environment; and contingency operations for freezer malfunction will be presented. The course will benefit not only biorepository operations managers, but also nurses, administrators of sample collection and storage entities and even research scientists who will better understand how biobanker practices align with and support their own goals.
Learning Objectives
- Share effective program and project launches
- Describe program governance
- Explain the establishment of a strong communication plan
- Discuss quality assurance and control
- Describe the process of controlling and mitigating risk
- Provide tips for managing stakeholder expectations
- Explain the importance of properly closing a project
- Provide guidelines for formatting and streamlining an SOP
- Discuss the contents to include in different SOP sections
- Describe training records and how to best maintain them
- Share the factors and circumstances a site auditor will want to see
- Describe the process of version controlling both training records and SOPs
- Explain disaster management and the need for backup SOPs
Who Should Attend
- Biobank and Biorepository Operations Managers
- Sample Collection and Storage Administrators
- Nurses
- Research Scientists
Instructors and Detailed Agenda
5:45 pm Welcome
6:10 Fundamentals of Building Effective Lab Service Programs
Stephanie Frahm, Senior Project Manager and Technology Developer, RUCDR Infinite Biologics, Rutgers University
Translating client requirements into a lab program producing high-quality biomaterial and data deliverables requires detailed upfront planning and an efficiently run lab. Assembling these moving parts into a high-functioning, successful program requires cutting-edge science and technology, plus an understanding of program management – how to stay within time, cost, scope and quality constraints to meet customer needs and ensure the program’s future growth and success. Based on my BioProcessing Solutions Alliance experience, I will address fundamentals of our successful strategic partnership.
7:00 Dinner Break
7:30 Controlled Documents: SOPs and Training Records
Colleen M. Mitchell, Joint Biorepository Operations Manager, Indiana University Genetics Biobank and Indiana Biobank
Maintaining proper documentation in a controlled environment is elusive and sometimes overwhelming. We present Indiana University Genetics Biobank’s approach to streamlining SOPs and maintaining training records. Topics include how to format an SOP and the contents to include in different sections, what a site auditor will want to see in training records and how to version control both training records and SOPs.
8:30 Interactive Q&A with Instructors and Participants
9:00 Close of Short Course
Course Length and Time
3.25 hours 5:45 – 9:00 p.m.
Course Date
September 16, 2014
FEE: $699 Commercial/ $399 Academic, Government, Hospital-Affiliated
ACCREDITATION
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 3.25 hours (0.325 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will email ACPE statements within three weeks of program completion.
ACPE#: 0778-0000-14-091-L01-P.
Released: 9/14.
*Separate registration required