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Routine Accurate Mass Detection for Forced Degradation Studies

AAPS | American Association of Pharmacueticals Scientists | Path Course Page

The best way to avoid costly surprises down the road during drug manufacturing is to apply the right methodologies from the beginning, to accurately identify and control impurities during drug development. Part of this process takes place at the formulation stage, where forced degradation studies are carried out to develop analytical procedures that will be implemented in a regulated environment during manufacturing.

What are the traditional methods and techniques, both in screening and characterization? How can routine accurate mass detection with streamlined software applications be used to collect more insightful data at this stage, to shape control strategies for QC analyses, and support regulatory filings?

In this eChalk Talk, we will look at how a French CRO successfully implemented these new technologies to improve analytical development services for their customers.

AAPS members, students, and academicians enjoy special pricing. Previews of each of the lectures are available. Participants have access to the course content for a 6 month period following purchase.

Course Objectives

Introduce the statute, regulation and guidance relationships.

Review positioning the quality pillars (GLP, cGMP, and GCP) in eCTD submissions.

Compare and contrast critical GLP roles and responsibilities from the perspectives of the Sponsor, Study Director, Principal Investigator and Quality Assurance.

Provide a detailed understanding of the relevant GLP formulation nuances.

Review ICH Q10 in-depth.

Gain insight into the value of linking development knowledge to manufacturing, and knowledge management to continuous improvement.

Differentiate how to perform appropriate quality investigations during development and commercial batch manufacturing, and when managing investigations of external vendors such as suppliers and CROs.

Discuss pertinent models for conducting clinical research, focusing on new drug development and approval.

Understand how to put GCP into action from obtaining Informed Consent, to composing a Protocol, to selecting Clinical Sites and ending with describing the Data Review Committee.