Establish Change Control for Pharmaceutical Stability Program 2014

Topics

• What type of CMC changes in the life cycle of a drug product
• Stability is defined as a critical quality attribute
• Distinguish between minor and major changes of a registration stability program
• How changes affect the stability profile of the product throughout the expiry
• Determine potential risks to manage these stability changes

Who should Attend

• Pharmaceutical scientists
• Quality Control managers and personnel
• Analysts and lab managers
• Manufacturers of raw material and ingredients
• Regulatory affairs
• QA managers and personnel
• Compliance scientists