There are eight types of water used in manufacturing drug products. And, it is of paramount importance to design, validate and control water systems used in the manufacture of drugs, biologics and medical devices.
This session by our expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA, is intended to discuss FDA requirements for water systems from a microbiological aspect for drugs, biologics and medical devices. In particular, it is intended to discuss microbial control, monitoring and validation of water systems.
This presentation will provide great opportunities for industry professionals to be better aware of and get more familiar with the FDA’s expectations for establishing water systems suitable for use in the manufacture of drugs, biologics and medical devices.
Who should attend?
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.