Topics
- Provide guidance on industry trends, regulatory feedback, and designs for a successful disinfection validation program which meet FDA and EMA scrutiny. Current 483`s, Warning Letters, and Field Experiences will be conveyed that allow end users to determine that best methods to validate their products against their isolates
- Design and implement and effective cleaning and disinfectant program to control the Cleanroom environment to minimize downtime and get the best product yield
- Learn how to develop a successful contamination control program with an emphasis on personnel practices, environmental controls, minimizing risks and avoiding common mistakes
- Microbial control in Oral Solid Dose manufacturing
- Learn how to start-up a new Cleanroon and re-establish control of a Cleanroom after a shut-downs or worse case events
- Learn how to troubleshoot excursions in Pharmaceutical and Biotech Operations
Who should Attend
Disinfectant Validation Managers, QA and QC Managers, Cleanroom Managers, Operations Managers, Regulatory Compliance Managers & Environmental Monitoring Managers, Personnel and contractors that clean and disinfect cleanrooms and Lean Managers from Biotech, Pharmaceutical and Medical Device companies.
