New medicines are developed every day to deliver medical needs and improve quality of life. Pharmaceutical companies spend an average of between 800 million to 1.2 billion dollars in R&D to bring a new drug to market. The analytical development program plays a critical role in the pharmaceutical industry, where much effort is spent on developing testing procedures to ensure quality, safety, and efficacy of new drug products. The effectiveness of Quality Control (QC) laboratories depends on the quality systems to stay in compliance with the FDA regulations.

This live interactive webinar will discuss different phases of the drug development process and the role of the QC laboratory. Good Manufacturing Practices (GMPs) regulations of the lab to establish the laboratory controls will be reviewed. The interactions between Quality Control (QC) and Quality assurance (QA) units will be clarified.

Analytical data are used to verify the quality and identity of the API and DP; therefore, it is important to maintain the QC lab in an FDA compliance state. Quality systems will be discussed as to how they support analytical functions. Quality programs such as metrology, testing methods, reference standards, materials, will be discussed. Warning letters and violation observations found with pharmaceutical QC laboratories will also be discussed.

Analytical methods are critical to the data collection; therefore, validation based on the Quality-by-Design concept will also be discussed to support analytical lifecycle management (ALCM).

Equipment plays a critical role in the QC lab. A metrology system will be introduced to support the QC laboratories. A reference standard program must be established to ensure the accuracy of the analytical testing. Training is also critical to ensure the analysts are qualified for release and stability testing. Also, a change control program according to ICH Q8, Q9, and Q10 will be discussed to ensure that the QC laboratories can maintain their compliance status throughout the product lifecycle.

Learning Benefits:

• Current drug development process
• Regulatory FDA, ICH and WHO requirements for pharmaceutical laboratories
• Lab controls requirements from cGMPs
• Discuss warning letters affecting the analytical labs
• Review GMP requirements related to the analytical labs
• Understand quality systems to support analytical functions

Time: 10:30 AM - 12:30 PM (Eastern New York Time)