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The course overview included clarification of similarities and differences among GMP requirement for the U.S., EU & Japan and creation of a globally compliant manufacturing process; Comply with the guidelines of all regulatory bodies by understanding the process of harmonization and the implementation of ICH Q7 and Q7A guideline documents in each region; Implementation of international requirements for production of Commercial as well as clinical trial supplies to become fully prepared for inspections; Examination of mutual recognition procedures and the types of information- sharing allowed among international regulatory agencies ;Understanding the role of Qualified Persons in a GMP controlled environment; Comply with Quality Systems Regulations and establish a thorough quality programme that ensures manufacturing efficiency ;Ensure manufacturing operations located in the U.S. are compliant with international requirement; Recent change in the Japanese drug approval system to increase approval chances in the region It was followed by a Case Study. Training Compliance with cGMP Requirement July 30-31 2007 Jubilant Organosys, Roorkee Faculty: Dr Thomas Colonna and Mr Stuart Green 24 participants This course included Current FDA, GMP requirement and avoidance of regulatory action; Maintenance of Compliance by correct interpretation of cGMP/GMP/QSR requirement.; Using PAT to develop innovative approach with a real time continuous approach to quality; Understanding the FDA’s risk based approach to GMP for assuring the compliance programme to target the risk areas ;Implementation of pharma strategies for process validation to enhance the product quality and manufacturing process efficiency; Establishment and maintenance of beneficial audit programme to avoid FDA as common trigger point; Conduct effective failure and Out of Specifications (OOS) investigation ;Utilization of Failure Mode Effect Analysis (FEMA) to eliminate failure before their occurrence ;Evolution of control measure within the laboratory to increase, efficiency and productivity of laboratory operations ;Development of consistent and thorough GMP documentation that is ready and Retrievable during FDA inspection ; Establishment of effective change control and CAPA system to account for errors and change ;Training of personal effectively to understand GMP compliance and increase their efficient. Training on Drug safety Surveillance and Epidemiology Aug 16-17, 2007, Lotus Labs ,Bangalore Dr Jean Paul Desylpere and Dr Kiran Marthak 28 participants This course covered Overview of domestic & International Safety Surveillance; Role of Epidemiology ; Industry Perspective; FDA Perspective; Definition and GPP & PRA; Learning of Risk Assessment ; Development of Risk Management Progranmme ; Knowledge of ICH guidelines related to safety ; New tools in Pharmacovigilence & Assessment of roles of database ; Data mining techniques in pharmacovigilence ; Knowledge of CIOMS ; Overview of Legal consideration of drug safety ; Review of Protocols of adverse event from regulatory reporting followed by a Case Study. Advanced Topic in Clinical Research and Drug Development 13-14, August 2007 at Green Business Center, Hyderbad. Dr Jean Paul Desylpere and Dr Kiran Marthak 8 participants ; Open Programme This course reviewed the identification and development of new therapeutic agents and the management of clinical development programmes through interactive lecture and Hands-on workshop training methods. Topics addressed include industry challenges, clinical operations, key documents, and quality concepts. The content for this course focused on drugs and biologics development. |