ComplianceOnline, Online Event
2013-11-07
Why Should You Attend: New medicines are developed every day to meet medical needs and improve quality of life. 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 session will discuss what type of changes exist in the product life cycle and how these changes can affect the stability profile of the pharmaceutical product through expiry. We will also discuss potential risks to manage these changes to the stability program. Learning Objectives: Upon completion of this session, attendees will understand the factors that would affect the stability program and how to establish the change control to support product marketing strategies. This session will also discuss the observations and infractions due to lack of change control system of the program. Areas Covered in the Webinar: - 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
- Distinguish between minor and major changes of a registration stability program
- Determine potential risks to manage these stability changes
Who will benefit: - Quality Control managers and personnel
- Pharmaceutical scientists
- Manufacturers of raw material and ingredients
- Analysts and lab managers
- QA managers and personnel
- Regulatory affairs
- Compliance scientists
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