When designing a cleanroom, many factors should be considered to adequately implement the requirements for an effective cleanroom design and validation. Otherwise, it can be costly and time-consuming later.
This audio conference by expert speaker Dr. David Lim is intended to discuss FDA regulations and the requirements for an effective cleanroom and facility validation as part of current good manufacturing practices (CGMP) for sterile drug and biological products.
Understand what firms should know about the statutory and regulatory requirements so that the industry can implement good manufacturing practices to ensure an effective cleanroom design and validation. This session will greatly help you understand and establish an effective environmental monitoring program in view of CGMP (USP, ISO and FDA recommendations).
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.