Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies - Application and Compliance to Ensure Safety of Biologic Therapeutics and Medical Devices 2012

Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies - Application and Compliance to Ensure Safety of Biologic Therapeutics and Medical Devices 2012 is a seminar dedicated to guidelines and strategies for conducting and managing a preclinical development program for biologic candidates (biologics, pharmaceuticals and medical devices) eventually leading to IND studies including:

• Target areas for potential compliance infractions, resolution of audit findings, and pertinent case studies regarding the issuance of 483s and warning letters
• Current global regulatory (FDA, ICH) directives, and the management of these mandates will ensure successful audits for compliance, and submissions

Who should Attend

R&D investigators, Executive management, Pre-clinical and clinical, Product development, QA/ QC, Regulatory affairs, Consultants, Marketing and Training.