Microbial Control in Oral Solid Dose Manufacturing

Why Should You Attend:

Training on personnel practices and microbial control of non-sterile manufacturing areas and process equipment are a critical part of your facility operations and overall control program to meet FDA, EMA, IMB, and MHRA regulations. This process involves updated personnel training and having a validated cleaning and disinfection program to control microbes on both product and non-product contact process equipment and cleanroom surfaces.

Areas Covered in the Webinar:

• General oral solid dose (OSD) manufacturing considerations
• Addressing bioburden and cleaning and sanitization or process equipment
• Discussing the most current methods for applying disinfectants, sanitizers, and sporicides on process equipment and in the cleanroom
• Control of bioburden with a validated cleaning and disinfection program
• Effective methods for controlling residues
• Necessary components will be discussed that will allow end users to be in compliance with FDA and EMA/European regulatory agencies

Who will benefit:

This webinar will provide valuable assistance to all FDA and EMA/European regulated manufacturers that need to validate their cleaning and disinfection programs, including manufacturers in the Pharmaceutical, Biotech, Medical Device, and Oral Solid Dose fields. Employees who will benefit include:

• QA and QC Managers and Personnel
• Disinfectant Validation Managers
• Operations Managers
• Cleanroom Managers
• Regulatory Managers
• Lean Managers
• Personnel and contractors that clean and disinfect cleanrooms
• EH&S Managers
• Regulatory Compliance Managers & Environmental Monitoring Managers