Change Control for the Stability Program GMP Requirements & A Review of the Potential Risks Involved
Live, Interactive Training Webinar
Date: Wednesday November 15, 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. The stability program is necessary for product registration, and changes to the product require additional stability studies. As part of GMP requirements, pharmaceutical companies must establish a change control system to monitor any change to the product, process or package. This live training session will discuss what type of changes exist in the product life cycle and how these changes can affect the stability profile of the product through expiry. We will also discuss potential risks to manage these changes to the stability program.
Learning Benefits:
- Stability defined as a critical quality attribute.
- What type of CMC changes in the life cycle of a drug product.
- How changes affect the stability profile of the product throughout the expiry.
- Distinguishing between minor and major changes of a registered stability program.
- Determining potential risks to manage stability changes.
Webinar outline and time breakdown:
Time*
10:15 AM Log-In Period
10:30 AM Introduction
Stability is defined as a critical quality attribute,
What type of CMC changes in the life cycle of a drug product,
How changes affect the stability profile of the product throughout the expiry,
11:30 AM 10 Minute Break
Distinguish between minor and major changes of a stability program,
Determine potential risks to manage these stability changes,
Changes in the middle of the stability program,
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
- Manufacturers of raw material and ingredients
- Pharmaceutical Scientists
- Compliance Scientists
- Analysts and Laboratory Managers
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>>>