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DTSTART;TZID=Asia/Kolkata:20220228T130000
DTEND;TZID=Asia/Kolkata:20220304T170000
DTSTAMP:20220118T074300
UID:MEC-a4d3af69a34ee0822adcbfc50bf1ded5@biiworld.com
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SUMMARY:Extractables and Leachables in Pharmaceutical Manufacturing: Strategies for Compliance
DESCRIPTION:\nReal Time Online Delivery – Live Training Sessions\nVirtual Attendance for 5 Days Training \nGuided Learning Hours – 20 (4 Hrs x 5 Days)\nComprehensive Learning Kit \n\nCourse Overview\nThe regulatory requirements concerning the control of extractables and leachables (E&L) have become much more onerous in recent years.\nThis 5 Day Online Course sets out the regulatory and scientific considerations in a logical, stepwise manner and offers practical advice for compliance. The course answers questions such as: “When is an extractable/leachable study necessary?”, and “How do I choose appropriate extraction conditions?”. Regulators will expect a risk-based approach to compliance, and the steps involved in an E&L risk assessment are described.\nTrainer’s Profile\nOur expert trainer has experience of 30+years in the pharmaceutical industry and a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist.\nAn expert in sampling and sample preparation, chromatography (liquid and gas), spectroscopy (atomic and molecular) and pharmaceutical dissolution testing. Ex Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016.\nA PhD in analytical chemistry, worked at a senior level in a number of industrial laboratories with responsibility for the development of analytical methods capable of quantifying very low levels of organic compounds in a wide range of different sample types. These included pharmaceutical raw materials, drinking water, industrial effluent and marine biota.\nOne of the respected specialists, helping operating companies to achieve changes and extend best practices & learning by conducting numerous global training courses.\nKey Takeaways\n\nLearn current regulatory requirements for container/closure qualification from an E/L perspective\nDevelop evaluation program (leveraging suppliers’ documentation and designing analytical studies)\nUnderstand the materials of construction – and their composition – of container closure systems, and how they could impact safety and efficacy\nIdentify and apply the principles of quality risk management to E&L studies\n\nWho Should Attend\nFor personnel of pharmaceutical companies and their suppliers who:\n\nAre responsible for qualification of extractables/leachables in quality control\nPerform leachables/extractables testing\nWork in quality control of packaging materials\nChoose and define polymeric, glass and rubber product contact materials\nManage materials in process development\nChoose and define Single Use Equipment for manufacturing\nDevelop materials sourcing strategies\nPharma Packaging and Device Engineers\nProduction Engineers, using SU systems\nRegulatory Affairs Officers\nPharma R&D Managers\nAnalytical Chemists, working on E&L\nQuality Assurance Officers\nToxicologists and Safety Assessors\n\n\nFor participation details contact\nMithun Siddartha\nmithun.siddartha@biiworld.com ( mailto:mithun.siddartha@biiworld.com )\n+1 780 851 7197 (Canada)\nFill the details below to request your Brochure\n\n \n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n×\n
URL:https://biiworld.com/trainings/extractables-and-leachables-in-pharmaceutical-manufacturing-strategies-for-compliance/
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