Course Description:
New medicines are developed every day to meet medical needs and improve quality of life and HPLC methods are widely used in R&D and QC pharmaceutical labs. Analytical methods establish acceptance criteria and monitor quality of drug products throughout their expiry. Therefore, validation becomes a critical process and it is important to understand requirements set forth by multiple regulatory agencies such as the ICH and the FDA.
This course will discuss different aspects of method validation, verification and transfer throughout the life cycle using Quality by Design approach (QbD). It will provide participants with an understanding of regulatory requirements in these areas. It will present critical principles of the transfer process, discuss different strategies and key factors that would influence the transfer, evaluate transfer packages and suggest how to handle transfer failures.
This 2-day comprehensive course will also discuss how to write protocol, establish acceptance criteria and document validation reports.
Learning Objective:
Upon completing this course participants will:
Understand GMP requirements for method validation
Understand ICH guidelines for validation of analytical procedures
Understand strategy options to transfer analytical procedures
Design validation protocol for analytical methods
Justify acceptance criteria for method validation
Understand stability indicating methods
Understand specificity and forced degradation studies
Implement validation protocols
Compile an effective validation report
Handle validation failures
Understand verification of pharmacopeia methods
Note: Use coupon code 232082 and get 10% off on registration.
New medicines are developed every day to meet medical needs and improve quality of life and HPLC methods are widely used in R&D and QC pharmaceutical labs. Analytical methods establish acceptance criteria and monitor quality of drug products throughout their expiry. Therefore, validation becomes a critical process and it is important to understand requirements set forth by multiple regulatory agencies such as the ICH and the FDA.
This course will discuss different aspects of method validation, verification and transfer throughout the life cycle using Quality by Design approach (QbD). It will provide participants with an understanding of regulatory requirements in these areas. It will present critical principles of the transfer process, discuss different strategies and key factors that would influence the transfer, evaluate transfer packages and suggest how to handle transfer failures.
This 2-day comprehensive course will also discuss how to write protocol, establish acceptance criteria and document validation reports.
Learning Objective:
Upon completing this course participants will:
Understand GMP requirements for method validation
Understand ICH guidelines for validation of analytical procedures
Understand strategy options to transfer analytical procedures
Design validation protocol for analytical methods
Justify acceptance criteria for method validation
Understand stability indicating methods
Understand specificity and forced degradation studies
Implement validation protocols
Compile an effective validation report
Handle validation failures
Understand verification of pharmacopeia methods
Note: Use coupon code 232082 and get 10% off on registration.
