PPT BIOTECH PRODUCTS   17-09-2019
                     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 
Masterclass
• Formulators Should Attend This biotech Products Masterclass
• Technology Transfer Should Attend This biotech Products 
Masterclass
• Manufacturing Management Should Attend This biotech 
Products Masterclass
• Validation Specialists Should Attend This biotech Products 
Mastercllass
BIOTECH PRODUCTS MASTERCLASS
• 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
• Manufacturing of the Drug Substance and IMP
• Requirements for processvalidation
• IMPs comparators and placebos
• Release specifications versus InProcess Controls, ICH 
guidelines
• Analytical methods throughout clinical development, Batch 
data
• The site master file (SMF)
• Manufacturing process changes during clinical development
• 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