Extractables and Leachables: Setting Up Early for Success with your CDMO

Explore information tailored for drug product research and manufacturers, delivering key insights into extractables, leachables, and implementation strategies. We will cover essential topics such as industry standards, regulatory intelligence, and success keys. This session offers practical guidance on timing, strategy, partner selection, and planning. 

• Extractables and Leachables insights
• Regulatory intelligence on FDA feedback and program successes
• Keys to success: Timing, strategy, partner selection, planning
• Simulated leachable studies: Differences and benefits

Speakers

Amanda Connor

Principal Scientist, Extractables & Leachables

Amanda Conner is a Principal Scientist, Extractables and Leachables with eleven years of analytical development, validation, technical writing, and specialty study design (E&L, Food Effect Studies, etc.) at Alcami.

Chris Williams

Director, Development Services

Chris Williams is a Director of Development Services with over 13 years of analytical development and specialty testing experience at Alcami.