Understanding Good Cell Culture Practices, GCCP, in Nonclinical In Vitro Safety Studies

A result of the initiative to reduce the use of animals for nonclinical safety testing, in vitro alternative methods have become more prevalent to evaluate the safety and toxicity of chemicals, pharmacologicals, biologicals and medical devices. GCCP practices have been proposed by ECVAM to help insure harmonization, standardization and rationalization of cell and tissue culture laboratory practices.

This talk will describe and show applications of GCCP which can be used in vitro assays to increase quality standards in the laboratory environment. The basic principles of the ECVAM Task Force will be discussed as well as other expert opinions on GCCP. A sample SOP for GCCP principles will be provided.

Areas Covered in the seminar:

• What are GCCP’s?
• ECVAM Task Force Overview.
• The GCCP initiatives.
• The basic objectives of GCCP.
• How to identify areas of improvement within your in vitro studies?
• How to assess the risk and establish best practices?
• 5 simple process to implement for any in vitro study.
• Integration to GLP and GMP regulations.
• Present a sample SOP for GCCP’s.

Who will benefit:

This webinar will provide valuable assistance to all regulated companies that use cell or tissue based laboratory practices, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

• Study Investigators of cell or tissue based practices assays
• Supervisors of cell or tissue culture based laboratories
• Study Directors of GLP studies
• QA Managers and Personnel
• Project Management
• Consultants
• Training
• Quality System Auditors

Instructor Profile:

Dr. Ann M. Wright, has been employed in the medical device industry for 15 years. She has successfully implemented and structured GLP studies within her organization for novel medical devices research and marketing submissions. She has made numerous presentations at various professional meetings highlighting the interaction of in vitro tissue culture with contact lens products and materials. She also has professional journal publications on both cellular biology and microbiology. She is a certified regulatory affairs professional and is study director and sponsor for GLP studies for product submissions. She has presented on line training, professional organization symposiums and provides both external and internal training to individuals on GLP guidelines. She recently supported the biotechnology initiative for RAPS and CRDF in Kazackhstan. Her career has involved fucosyltransferase studies, P. falciparum tissue culture, recombinant DNA studies with P. putida , education and presently, is involved in cell biology/ toxicology methods and immunological assays involved with the medical device industry. Her undergraduate studies were at Hope College ; Holland , Michigan and she received doctoral degree in pharmaceutics from Mercer University ; Atlanta , Georgia . She is a member of numerous professional organizations and regularly increases her knowledge base through training and meeting attendance. She enjoys a balanced life of travel, outdoor sports, gardening, bead arts and cooking. She resides in Georgia with her partner, John, and is the mother of two grown sons.

Follow us :