To Validate or Not To Validate: A Daily Question for the Pharmaceutical Scientist (Pharmaceuticals)
Venue: Online Event
|Event Date/Time: Sep 20, 2012||End Date/Time: Sep 20, 2012|
Why Should You Attend:
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 especially with the changes throughout the drug development process. It is important to understand validation requirements set forth by ICH and FDA.
This 90-minute webinar will present the common deficiencies in relation to method validation, outline regulatory requirements and the change control process needed to stay in compliance.
Upon completion of this session, attendees will learn key factors that would affect validation process of analytical procedures. One must understand validation characteristics and able to determine when re-validation would need to take place.
Areas Covered in the Seminar:
- Deficiencies related to Method Validation.
- Factors affecting Quality of Medicines.
- Validation Characteristics.
- Validation vs. Re-Validation plan.
- Tracking record of validation project.
- Change control of validation.