Uploaded on Sep 18, 2019
Biotech Products Training In Europe. Biotech Products Training In Europe. Regulatory framework for Clinical trials of biotech Products Training In Europe The quality challenges for Biotech IMPs GMP requirements for IMPs. This Training is your roadmap to maximizing portfolio value in accordance with management’s strategic and financial goals. Designed to improve companies’ abilities to progress compounds from the pre-clinical stage to commercial brand management. https://aureliusglobalmasterclass.com/events/quality-requirements-for-biotech-products/
PPT BIOTECH PRODUCTS Europe 18-09-2019
AURELIUS GLOBAL MASTERCLASS LEARN FROM THE BEST IN THE WORLD ABOUT US • Aurelius Corporate Solutions wants to be seen and accepted as one stop shop for all industry specific master-classes across the globe, thereby making the line managers well versed with the acceptable technology and business practices, adopted worldwide. WHO ARE WE ? WHAT WE DO ? • WHO SHOULD ATTEND THIS BIOTECH PRODUCTS MASTERCLASS IN AUSTRIA? • Process Engineering Should Attend This biotech Products Training • Formulators Should Attend This biotech Products Training • Technology Transfer Should Attend This biotech Products Training • Manufacturing Management Should Attend This biotech Products Training • Validation Specialists Should Attend This biotech Products Training BIOTECH PRODUCTS TRAINING • Learning o How to optimize budget by minimizing downtime and executing smoother Shutdown & Turnaround project • Solving o Technical and management issues of Shutdown & Turnaround’s enhancing life cycle while maintaining budget • Providing o A detailed view of the turnaround management system process and procedural framework for both petrochemical plants and refineries KEY TOPICS • KEY TOPICS OF BIOTECH PRODUCTS TRAINING IN EUROPE • • Regulatory framework for Clinical trials of Biotech-IMPs • The quality challenges for BiotechIMPs GMP requirements for IMPs • Manufacturiing of the Drug Substance and IMP • Requiirements for processvalliidation • IMPs comparators and placebos • Rellease speciifications versus InProcess Controlls, ICH guiidelliines • Anallyticall methods throughout clliiniicall devellopment, Batch data • The siite master fille (SMF) • Manufacturiing process changes duriing clliiniicall devellopment • DATE & TIMEStart Time • 9:00 am • 05–December • , 2019, • Finish Time • 5:00 pm • 06-December • , 2019 • Address • Amsterdam, The Netherlands CONTACT US Email:[email protected] Phone: +44 2032 398083 Our Page : http://bit.ly/2OXZ3uY
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