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SUMMARY:Data Integrity and Governance Workshop
DESCRIPTION:Live Oak Workshops\, in collaboration with Sidley Austin\, are designed to equip you with the knowledge and critical thinking strategies that lead to success in the advancement of your GXP career. As worldwide regulatory expectations in the world of data integrity and data governance change\, our workshops prepare you with the skills necessary to interpret regulations\, guidance\, and regulatory action into simple approaches for managing your everyday GXP responsibilities with the efficiency needed to thrive. \nMonday\, September 9\, 2024 – Tuesday\, September 10\, 2024 | Ahmedabad\, India\nThursday\, September 12\, 2024 – Friday\, September 13\, 2024 | Hyderabad\, India \nSign up now to join us as we discuss\, debate\, question\, and tackle interesting regulatory case studies in the world of data integrity and data governance. \nWe are excited to now offer this worship in both Ahmedabad and Hyderabad this October. Click here to see the full two-day agenda. \nInstructors include former FDA India Office alums: \nPeter Baker\, President\, Live Oak\nFormer FDA Investigator\nPeter Baker is a GXP consultant focused on improving the quality of medicines by providing training and consulting services to organizations looking to improve the quality of their data integrity assurance strategy. Pete is a former FDA investigator whose Agency leadership included serving as Assistant Country Director (Drugs) in New Delhi\, where he performed high risk cGMP inspections of human drug manufacturers throughout India and the surrounding region\, conducted a variety of training and development exercises for manufacturers and foreign regulators\, performed joint GMP manufacturing inspections with a variety of foreign regulatory bodies\, and conducted joint investigations alongside local and regional investigation teams to facilitate harmonized regulatory actions. In 2013\, he was recognized as FDA Investigator of the year due to a significant number of FDA regulatory actions taken in India\, including product recalls and import bans based on inspections where breaches in data integrity were uncovered which affected a wide variety of products in US distribution. \nJay Jariwala\, Senior Director\, Regulatory Compliance\, Sidley\nFormer FDA Regulator\nFor over 13 years\, Jay served as an FDA regulator and leader at multiple FDA centers\, including CDER\, the Center for Devices and Radiological Health (CDRH)\, and the Office of the Commissioner\, applying the agency’s laws\, regulations\, guidance\, and other technical and administrative policies on drugs\, medical devices\, and combination products to policy development\, facility inspections\, compliance\, enforcement\, and approval processes. His FDA leadership experience includes serving as assistant country director (Drugs) and supervisory Consumer Safety officer in the agency’s India Office in New Delhi\, where he managed a team of investigators for all facility inspections conducted by the India Office and compliance follow-up. In addition to his responsibilities for resource planning and operational oversight for violative establishment inspection assessments and resulting regulatory actions\, Jay trained FDA investigators on current good manufacturing practice (CGMP) requirements — particularly data integrity and quality investigations. \nDan Roberts\, Senior Director\, Regulatory Compliance\, Sidley\nFormer FDA Investigator\nDan Roberts evaluates and assesses pharmaceutical quality systems and focuses on detecting and remediating data integrity concerns and evaluating compliant automated manufacturing processes and related computerized systems. He provides guidance and assists clients in responding to FDA-483 observations\, corresponding with regulatory agencies\, and conducting mock FDA facility audits. Dan has over 20 years of government regulatory and pharmaceutical/biopharmaceutical industry experience. He was an FDA investigator for eight years\, including two years as the primary point of contact for conducting pharmaceutical inspections at the FDA India office located at the U.S. Embassy in New Delhi. He was also the first lead investigator for the first biosimilar inspection conducted by the FDA in India. \nJim Johnson\, Partner\, Sidley\nFormer FDA Associate Chief Counsel\nJim Johnson guides life sciences companies through complex FDA compliance and enforcement matters\, including inspections\, current good manufacturing practices (GMP) requirements\, data integrity responsibilities\, product quality issues\, pharmacovigilance obligations\, and enforcement actions. Jim previously served as Associate Chief Counsel for Enforcement in the FDA’s Office of the Chief Counsel\, where he handled GMP enforcement and provided legal counsel on a range of inspectional and compliance issues to agency components\, particularly the FDA’s Office of Regulatory Affairs (ORA) and Center for Drug Evaluation and Research’s (CDER) Office of Compliance. Jim uses his extensive agency and private practice experience to assist pharmaceutical and biotechnology companies worldwide\, regularly conducting GMP assessments and investigations\, resolving warning letters and import alerts\, and appearing in front of the FDA on behalf of companies to resolve enforcement actions. \nDiscounts and Additional Information: \n\nContracts info@liveoakqa.com for groups of five or larger and receive a 10% discount code for checkout\nTea Breaks and lunch are included in the workshop.
URL:https://goodlifesci.sidley.com/event/data-integrity-and-governance-workshop/
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