Biotech Products Training  in Europe
                     AURELIUS GLOBAL 
MASTERCLASS
Biiotech  Produtc    traiiniing  iin  Europe  By
AURELIIUS  GLOBAL  MASTERCLASS
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  THIIS  BIIOTECH  PRODUCTS  MASTERCLASS  
IIN  AUSTRIIA?
Prrocess  Engiineerriing  Shoulld  Attttend  Thiis  Biiottech  Prroductts  IIn  house  
ttrraiiniing
Forrmullattorrs  Shoulld  Attttend  Thiis  biiottech  Prroductts  Biiottech  Prroductts  
IIn  house  ttrraiiniing
Technollogy  Trransfferr  Shoulld  Attttend  Biiottech  Prroductts  IIn  house  
ttrraiiniing
Manuffactturriing  Managementt  Shoulld  Attttend  Thiis  Biiottech  Prroductts  
IIn  house  ttrraiiniing
Valliidattiion  Speciialliistts  Shoulld  Attttend  Thiis  Biiottech  Prroductts  IIn  
house  ttrraiiniing
Biotech Products in house training
Learniing
o  How  tto  opttiimiize  budgett  by  miiniimiiziing  downttiime  and  
executtiing  smoottherr  Shuttdown  &  Turrnarround  prrojjectt
Sollviing
o  Techniicall  and  managementt  iissues  off  Shuttdown  &  
Turrnarround’’s  enhanciing  lliiffe  cyclle  whiille  maiinttaiiniing  
budgett
Prroviidiing
o  A  dettaiilled  viiew  off  tthe  tturrnarround  managementt  systtem  
prrocess  and  prrocedurrall  ffrrameworrk  fforr  botth  
pettrrochemiicall  pllantts  and  rreffiinerriies
KEY TOPICS 
KEY  TOPIICS  OF  BIIOTECH  PRODUCTS  TRAIINIING  IIN  
EUROPE
•  Regullattorry  ffrrameworrk  fforr  Clliiniicall  ttrriialls  off  Biiottech-IIMPs
•  The  qualliitty  challllenges  fforr  BiiottechIIMPs  GMP  
rrequiirrementts  fforr  IIMPs
•  Manuffactturriing  off  tthe  Drrug  Substtance  and  IIMP
•  Requiirrementts  fforr  prrocessvalliidattiion
•  IIMPs  comparrattorrs  and  pllacebos
•  Rellease  speciiffiicattiions  verrsus  IInPrrocess  Conttrrolls,,  IICH  
guiidelliines
•  Anallyttiicall  metthods  tthrroughoutt  clliiniicall  devellopmentt,,  
Battch  datta
•  The  siitte  mastterr  ffiille  (SMF)
•  Manuffactturriing  prrocess  changes  durriing  clliiniicall  
devellopmentt
Start  Tiime
9:00  am
05–DecembeDr ATE & TIME
,  2019,  
Fiiniish  Tiime
5:00  pm
06-December
,  2019
Address
Amsterdam,,  The  Netherllands
   Email:
[email protected]
Phone: +44 2032 398083
   Our Page 
:aurelliiusglloballmastercllass.com
CONTACT US