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DTSTART;TZID=Asia/Kolkata:20201123T100000
DTEND;TZID=Asia/Kolkata:20201126T150000
DTSTAMP:20200820T140200
UID:MEC-9e406957d45fcb6c6f38c2ada7bace91@biiworld.com
CREATED:20200820
LAST-MODIFIED:20200902
PRIORITY:5
TRANSP:OPAQUE
SUMMARY:Effective Pharmaceutical Technology Transfer
DESCRIPTION:\nReal Time Online Delivery – Live Training Sessions\nVirtual Attendance for 4 Days Training \nGuided Learning Hours – 20\nComprehensive Learning Kit \nUse of Consultative Approach\n\nCourse Overview\nTransfer of pharmaceutical manufacturing processes and analytical methods between facilities or laboratories is an essential part of the pharmaceutical product lifecycle. The technology transfer must take place between development and commercialization. A solid and descriptive technology transfer process based on trust between the sending & receiving units is crucial to be successful. \nThis 4 Day online training event; a combination of virtual lectures explaining the concepts and practical virtual workshop activities based on practical technology transfer (TT) example and your current TT needs. Potential complexity of technology & product transfer, importance of planning & project management in technology transfer (TT) and technology transfer (TT) fit in the lifecycle of a pharmaceutical product.\nMain focus & highlight of this workshop will be the use of consultative approach and unlike a regular point to point delivery. It will be backed by real situations, interactive approach, group exercises and multiple case studies. \nGuidelines\n\nICH Q10: Pharmaceutical Quality System\nICH Q9: Quality Risk Management\nICH Q8,11: Pharmaceutical and drug substance development\nFDA Process validation lifecycle\nEMA Process Validation\nISPE Good practise Guide: Technology Transfer\n\nTrainer’s Profile\nOur expert trainer has experience of 20+years in the pharmaceutical industry. \nA consultant, specialised in the science & risk-based concept of pharmaceutical development and manufacturing including quality by design (QbD), process analytical technology (PAT), process validation lifecycle (PV), good manufacturing practice (GMP), quality risk management (QRM) and the related regulatory & compliance aspects. Over the years held various management & specialist portfolios; head of QC, PAT and QBD, technology transfer assignment with innovator & generic companies and pharma industries 4.0 projects involvement of late.\nAn expert in implementing a lifecycle approach to process validation, active in shaping the international QBD concept based on ICH Q8-11 guidelines. 15+ years association with ISPE including being the chair of PQLI control strategy team. One of the co-authors of the ISPE PQLI good practice guide (2011), a well respected speaker & trainer at different conferences, seminar & workshop.\nKey Takeaways\n\nLearn and explore the technology transfer scope, team & charter (introduction & explanation of tools), technology transfer process & standard operating procedures\nDevelop technology transfer ‘operation readiness’ at the receiving site \nUnderstand the high level technology transfer proposal, risk assessment & technology transfer plan, efficient technology transfer fundamental principles\nIdentify technology transfer challenges, methodology & regulatory expectation \nUpgrade your skill on QRM tools for technology transfer, risk assessment on what could go wrong during & after transfer\n\nWho Should Attend\n\nPharmaceutical technologists\nRegulatory Affairs\nEngineering \nProject Management and Planning \nFormulation and Process Development/Validation \nQuality Assurance\nAnalytical Methods Development \nPackage Development/Engineering \nManufacturing and Technical Support \nTechnology scale-up and transfer managers\nValidation and qualification specialists\nOperation managers\nR & D\n\n \n\nFor participation details contact\nSamuel Isaac\nsamuel.isaac@biiworld.com ( mailto:samuel.isaac@biiworld.com )\n+1 786 633 1223(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/effective-pharmaceutical-technology-transfer-nov-23-26/
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