BIOTECH PRODUCTS TRAINING
                     AURELIUS GLOBAL 
MASTERCLASS
Biiottecch  Prroduccttss
Traiiniing  
AURELIUS GLOBAL MASTERCLASS
ABOUT US
 Aurelliius  Corporate  Sollutiions  wants  to  be  seen  and  
accepted  as  one  stop  shop  ffor  allll  iindustry  speciiffiic  
master--cllasses  across  the  gllobe,,  thereby  makiing  
the  lliine  managers  wellll  versed  wiith  the  acceptablle  
technollogy  and  busiiness  practiices,,  adopted  
worlldwiide..
WHO ARE WE ?
WHAT WE DO ?
 WHO  SHOULD  ATTEND  THIIS  BIIOTECH  PRODUCTS  TRAIINIING  IIN  AUSTRIIA??
 Prroccessss  Engiineerriing  Shoulld  Attttend  Thiiss  Biiottecch  Prroduccttss  IIn  ttrraiiniing  IIn  
Eurrope
 Forrmullattorrss  Shoulld  Attttend  Thiiss  biiottecch  Prroduccttss  Biiottecch  Prroduccttss  IIn  
--housse  ttrraiiniing
 Tecchnollogy  Trranssfferr  Shoulld  Attttend  Biiottecch  Prroduccttss  ttrraiiniing  iin  Eurrope..
 Manuffacctturriing  Managementt  Shoulld  Attttend  Thiiss  Biiottecch  Prroduccttss  IIn  housse  
ttrraiiniing
 Valliidattiion  Specciialliissttss  Shoulld  Attttend  Thiiss  Biiottecch  Prroduccttss  ttrraiiniing  iin    
Eurrope
Biotech Products training in Europe
 Learniing
o  How  tto  opttiimiize  budgett  by  miiniimiiziing  downttiime  and  
executtiing  smootther  Shuttdown  &  Turnaround  projjectt
 Sollviing
o  Techniicall  and  managementt  iissues  off  Shuttdown  &  
Turnaround’’s  enhanciing  lliiffe  cyclle  whiille  maiinttaiiniing  budgett
 Proviidiing
o  A  dettaiilled  viiew  off  tthe  tturnaround  managementt  systtem  
process  and  procedurall  fframework  ffor  botth  pettrochemiicall  
pllantts  and  reffiineriies
KEY TOPICS 
 KEY  TOPIICS  OF  BIIOTECH  PRODUCTS  TRAIINIING  IIN  EUROPE
 •  Regullattory  fframework  ffor  Clliiniicall  ttriialls  off  Biiottech--IIMPs
•  The  qualliitty  challllenges  ffor  Biiottech  IIMPs  GMP  requiirementts  
ffor  IIMPs
•  Manuffactturiing  off  tthe  Drug  Substtance  and  IIMP
•  Requiirementts  ffor  process  valliidattiion
•  IIMPs  comparattors  and  pllacebos
•  Rellease  speciiffiicattiions  versus  IIn  Process  Conttrolls,,  IICH  
guiidelliines
•  Anallyttiicall  metthods  tthroughoutt  clliiniicall  devellopmentt,,  Battch  
datta
•  The  siitte  mastter  ffiille  ((SMF))
•  Manuffactturiing  process  changes  duriing  clliiniicall  devellopmentt
 Start  Tiime DATE & TIME
 9::00  am
 05–December
 ,,  2019,,  
 Fiiniish  Tiime
 5::00  pm
 06--December
 ,,  2019
 Address
 Amsterdam,,  The  Netherllands
CONTACT US
      Emaiill::[email protected]
Phone::  +44  2032  398083
      Our  Page  ::aurelliiusglloballmastercllass..com