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This 3 hour GLP virtual seminar will discuss various GLP regulations (FDA/OECD GLP's) along with highlighting roles and responsibilities of management and key personnel involved in drug development, safety & toxicity evaluation and QAU function in GLP testing facilities.
Why should you Attend: This 3 hour GLP Webinar will cover some of the major requirements, definitions and elements of the various GLP regulations, and the FDA/OECD GLP's. it will discuss the strategies to apply in effective implementation of a compliant GLP program with involvement and interactions and Case Studies and group exercise included in this highly interactive course presentation.
Areas Covered in the Session:
Introduction: Background of GLP's
Quality System Perspectives
Organization and Personnel
QAU: Audits and Responsibilities
Who Will Benefit:
Dr. Shib Mookherjea is a globally acclaimed speaker and consultant and has extensive experience in R&D, quality assurance, and quality management and teaches Methods Development, Validation Procedures, and Conformity Assessment in the Analytical Laboratory; Qualification and Validation of Laboratory Instruments and Equipment for Regulatory and QS Compliance (IQ, OQ, PQ); and the webcast Cleaning Validation and Compliance Issues for Pharma, Biotech and Medical Device Industries.