Chemistry, Manufacturing, and Controls (CMC) programs are an integral part of the development process which brings a drug from the preclinical phase to the market. Without a CMC program that is properly integrated with the clinical, non-clinical, and marketing programs, the entire development cycle can be delayed, resulting in lost time, revenues and market life cycle. However, the extent of necessary activities in CMC programs can vary depending on the development phase of the drug.

This audio conference explores how the skillful combination of drug characterization, manufacturing and packaging processes, analytical test methodology, compliance with applicable regulations and adequate documentation all help to ensure that the CMC portions of an application meet the necessary requirements, as well as supporting the clinical and nonclinical studies being performed to establish the safety and efficacy of the drug.

This audio conference covers:

• Components of CMC programs
• CMC activities at various phases of development
• General CMC activities for drug substances
• Compliance activities for CMC programs
• General CMC activities for drug products

About the speaker:

Miguel de Soto-Perera, PhD, is Vice President of Pharmaceutical Sciences at Beckloff Associates, Inc. (BAI). He holds a Doctorate in Electroanalytical Chemistry and a Master’s Degree in Analytical Chemistry, both from the University of Massachusetts at Amherst, and has nearly 30 years of experience in the pharmaceutical industry. He also has extensive teaching experience at the undergraduate and graduate levels, and is a regular lecturer at regulatory workshops offered by BAI, both domestically and internationally.

Dr. de Soto-Perera began his career as Senior Analytical Chemist with Dow Chemical before joining BAI in 1995. His responsibilities at BAI have specifically included performing cGMP audits and developing cGMP compliance programs for APIs and drug products in various countries. In his current position, he is responsible for all the managerial, business, and technical aspects of one of the Chemistry, Manufacturing, and Control (CMC) groups, which includes personnel located in offices in Overland Park, KS and San Diego, CA.

Who should attend?

• CMC Specialists
• Quality Assurance & Quality Control
• Regulatory Affairs
• Research & Development
• Operations Managers