Life-Cycle Management (LCM) of Analytical Procedures and Key Validation Parameters
FDA, ICH and USP Requirements
Live, Interactive Training Webinar
Date: Tuesday September 26, 2023
Time: 10:30 am - 12:30 pm ET (New York Time)
Instructor: Kim Huynh-Ba Biography>>>
Registration Form ►New medicines are developed every day to meet medical needs and improve quality of life. Analytical procedures are used to establish acceptance criteria and monitor quality of drug products. Therefore, validation becomes a critical process to provide assurance that the procedure meets the identified intended purpose. A discussion of life-cycle management of analytical procedure will also be discussed with an update of new validation regulation.
This live training webinar will introduce regulatory requirements from FDA, ICH and USP, discuss the highlights of different validation parameters and how to manage the change throughout the drug development process to stay in compliance.
Learning Benefits:
- Key factors that affect the validation process of analytical procedures.
- Understand validation characteristics.
- Determine when re-validation would need to take place.
Webinar outline and time breakdown:
Time*
10:15 AM Log-In Period
10:30 AM Introduction
Regulatory requirements from the FDA,
A review of ICH and USP validation,
Factors affecting Quality of Medicines,
11:30 AM 10 Minute Break
Validation Characteristics,
When re-validation is needed,
Verification vs validation,
12:30 PMLive Questions & Discussion
*Please note all times are Eastern Time (New York Time)
This live training webinar includes the following for each registered attendee:
- A copy of the presentation slides
- A certificate of training for attendee training records
Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:
- Quality Control
- Quality Assurance
- Regulatory Affairs Professionals
- Validation
- Auditors
How to Attend:
All Pharma Webinars live training programs audio and visuals are delivered via Cisco WebEx with a basic system requirement of a computer with internet access. You do not require a Webex account to join Pharma Webinars’ live training courses, participants receive an email invitation that provides the access you need to join the meeting.
Instructor: Kim Huynh-Ba
Kim has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. Prior to Pharmalytik, she held technical positions in drug development at AstraZeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. Her experiences range from analytical development to supporting CMC activities of multiple regulatory submissions, addressing regulatory responses to observations or investigations, or developing stability submission strategies.
She is an Adjunct Professor at Temple University-School of Pharmacy, Illinois Institute of Technology and Widener University. Kim currently is a member of United States Pharmacopeia (USP) General Chapter Expert Committee (2010-2015) and USP’s Reference Standard Project Team (2009-2010). She is also a member of the CHPA’s Impurities Breakout Group. She is chair of AAPS APQ Distance Learning and organized several APQ Open Forums. She serves on the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS). She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” published in 11/2008, and also “Pharmaceutical Stability Testing to Support Global Markets” published in 01/2010… Full Bio>>>