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 cepat@usp.org.

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