Corporate Events Management Associates (CEMA) will be organizing exclusive one day workshops on Good Laboratory Practices (GLP) at Hans Plaza in Delhi on June 21 and at Peninsula Grand in Mumbai on June 23.
This one day course will cover some of the major requirements, definitions and considerations for conducting GLP studies. The conducting of GLP studies has critical importance in the support of product registration in the pharmaceutical, biotechnology as well as other regulated industries.
This workshop aims at highlighting the roles, responsibilities and duties of key management, supervisors, scientists, principal investigators, regulators, QAU and other personnel in GLP facilities, contract laboratories, research institutes, CRO’s or other organizations engaged in the conduct of GLP studies and other non-clinical studies related to drug development, safety & toxicity studies and various targeted evaluations.
The objective of the course include: Learning about the various significant and highly responsible roles that are played by management, study directors and QAU personnel in a GLP facility; Familiarizing with some of the delineations and intricacies of responsibilities and accountability in maintaining testing facilities engaged in the conduct of GLP studies; Developing strategies in effective implementation of a compliant GLP programme with involvement, interactions and case studies included in this highly interactive course presentation.
The topics covered include: GLP - purpose / history, OECD principles of GLP, key persons in GLP , archives and archivist, standard operating procedures and do's and don'ts of GLP.
Those who should attend the workshop include management, study directors, scientists, principal investigators, toxicologists, QA managers, study monitors, laboratory professionals, regulatory affairs officials, archivists and QAU personnel, GLP coordinators, auditors from various contract laboratories, CRO’s, CMO’s and research facilities conducting and assessing GLP studies needing compliance to GLP’s
The workshop is conducted by Dr Mukul Pore, director Intox Pvt Ltd who has vast experience over a period of two decades in toxicology and product safety assessment, involving designing, conducting, reporting and co-ordinating toxicology studies in addition to providing scientific and regulatory expertise.
For more details contact Sanjana Sharma email ID:sanjana@corporateevents.co.in