Cell Therapy GTP and GMP Facilities: Design and Operation ... · 7/17/2020 · 17JUL2020 PACT Web...
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PACT Web Seminar Please Join Us! Friday, July 17, 2020 12:00-1:00 pm ET Intended Audience: Scientists, Researchers, Lab Directors, Regulatory Affairs Managers and QA/QC Managers, and Technologists specializing in cell therapy Fee: No Charge This web seminar will focus on academic cell therapy laboratory design and use to make the most of existing facilities and inform participants planning new facility construction. Dr. Linda Kelley will discuss the use of existing ISO 7 and ISO 8 facilities as it pertains to current manufacturing demands and Dr. Amittha Wickrema will discuss considerations for design of new GMP facilities. The presentation will be followed by a Question and Answer session. Registration is open! Register online at www.pactgroup.net . Attendees will receive an email detailing audio and web access requirements. CE INFORMATION: AMA PRA Category 1 Credits™ ASCLS P.A.C.E. and FL Board of Clinical Laboratory Personnel credit available see website for details -PACT Mission- Provide assistance for cellular therapy translational research and the manufacture of cellular therapy products for pre-clinical and early phase clinical studies. This project has been funded in whole or in part with Federal funds from the NHLBI, NIH under Contract No. HHSN268201600020C. -Speakers- Amittha Wickrema, PhD- Director, Advanced Cellular Therapeutics Facility; Director, cGMP Cell and Tissue Based Processing Facility, University of Chicago Medical Center Linda Kelley, PhD– Director, Cell Therapy Facility, Moffitt Cancer Center Cell Therapy GTP and GMP Facilities: Design and Operation to Optimize Space to Meet Manufacturing Needs Visit www.pactgroup.net for information on the PACT program. -Objectives- • Identify FDA regulatory guidelines for cellular therapy facility design, validation and operations. • Describe the steps needed to incorporate FDA guidelines for cellular therapy facility design, validation and operations. • List examples of ways to best utilize existing facilities and expansion for the greatest flexibility. • Identify key design features to successfully accomplish the functional requirements of the facility. • Describe the steps needed to organize and manage the project from planning to commissioning.
Transcript of Cell Therapy GTP and GMP Facilities: Design and Operation ... · 7/17/2020 · 17JUL2020 PACT Web...
PACT Web Seminar
Please Join Us!
Friday, July 17, 2020
12:00-1:00 pm ETIntended Audience:
Scientists, Researchers, Lab Directors, Regulatory Affairs
Managers and QA/QC Managers, and Technologists
specializing in cell therapy
Fee: No Charge
This web seminar will focus on academic cell therapy laboratory design and use tomake the most of existing facilities and inform participants planning new facilityconstruction. Dr. Linda Kelley will discuss the use of existing ISO 7 and ISO 8 facilities asit pertains to current manufacturing demands and Dr. Amittha Wickrema will discussconsiderations for design of new GMP facilities. The presentation will be followed by aQuestion and Answer session.
Registration is open!Register online at www.pactgroup.net.
Attendees will receive an email detailing audio and web access requirements.
CE INFORMATION: AMA PRA Category 1 Credits™
ASCLS P.A.C.E. andFL Board of Clinical Laboratory Personnel
credit available see website for details
-PACT Mission-
Provide assistance for cellular therapy translational research and the manufacture of cellular therapy products for pre-clinical and early phase clinical studies.
This project has been funded in whole or in part with Federal funds from the NHLBI, NIH
under Contract No. HHSN268201600020C.
-Speakers-Amittha Wickrema, PhD- Director, Advanced Cellular Therapeutics Facility; Director, cGMP Cell and Tissue Based Processing Facility, University of Chicago Medical Center
Linda Kelley, PhD– Director, Cell Therapy Facility, Moffitt Cancer Center
Cell Therapy GTP and GMP Facilities: Design and Operation to Optimize Space
to Meet Manufacturing Needs
Visit www.pactgroup.net for information on the PACT program.
-Objectives-• Identify FDA regulatory guidelines for cellular therapy facility design, validation
and operations.
• Describe the steps needed to incorporate FDA guidelines for cellular therapy facility design, validation and operations.
• List examples of ways to best utilize existing facilities and expansion for the greatest flexibility.
• Identify key design features to successfully accomplish the functional requirements of the facility.
• Describe the steps needed to organize and manage the project from planning to commissioning.
