Analytical Method this course offered by Validation USP ... · FDA, ICH and USP have all recognized...
Transcript of Analytical Method this course offered by Validation USP ... · FDA, ICH and USP have all recognized...
AnalyticalMethod
Validation (AMV)
usp.org/ghana
Don’t miss this course offered by USP–Ghana’s CePAT facility
Analytical Method Validation (AMV)Course Overview: One of the most
critical factors in developing and marketing
pharmaceutical drug substances and
drug products today is to ensure that the
analytical methods used for their analysis
can generate valid data on which business
and regulatory decisions can be made.
FDA, ICH and USP have all recognized
the importance of this to the drug
development process and have separately
expanded method validation requirements
in recent years. However, with only limited
guidance, medicines manufacturers and
regulators have been left to interpret how
to adequately comply with the regulations.
This course will provide a broad
understanding and knowledge of the
method validation processes as well
as techniques to navigate dif� culties
encountered in validating methods
to comply with all relevant regulatory
requirements. During the “hands-on”
part of this training, participants will be
shown examples of actual AMVs of HPLC,
GC, UV/Vis, Dissolution and titration
methods for small organic molecules and
will be guided to carry out an AMV for a
pre-selected method. Mathematical and
statistical treatments of validation data
will also be discussed. GPH036M_2017-01
Duration: Five (5) Days
Location: USP–Ghana/CePAT
Date:
Cost:
facility Accra, Ghana January 2018 Request for Quote
Early Bird: 10% Discount
For more information or to register, visit usp.org/cepat or contact CePAT at [email protected].
About USP–Ghana/CePAT
Established in Ghana by
United States Pharmacopeial
Convention
Built capacities of about
270 professionals from
40 countries in Africa in
medicines registration,
GMP, and Quality Control
Center is ISO 9001 Certi� ed
Testing Lab is ISO/IEC
17025:2005 accredited