Webinar: Preparing for USP 797 and 800 – No Time to Rest
Thursday, June 14, 2018
1:00 – 2:00 PM EST
Navigating and complying with the new USP 800 standards and proposed USP 797 standards is complex, time-consuming, and often expensive. The December 1, 2019, deadline for compliance may seem far off; but hospitals must act now because it will be a long, difficult road to compliance. These new standards provide additional infrastructure requirements, which many organizations will struggle to meet given limitations involving time, costs, and understanding of compliance elements related to facility design, engineering controls and architecture. The deadline allows very little time to plan for the design and construction necessary to achieve compliance.
Industry surveys indicate less than 50% of pharmacies have plans for cleanroom renovations although gap assessments conducted by EH&E have shown less than 20% of facilities are compliant with current regulations. Costs associated with renovations range from $100,000 to upwards of $2 million.
This webinar will prepare pharmacies for the upcoming challenges and is designed to provide a better understanding of the changes, potential impacts, and next steps so informed decisions regarding operations and budgets can be made.
- USP 797 and 800 regulations – what has changed and strategies for compliance.
- State of the industry and current trends.
- Measures to protect the environment during construction in a compounding pharmacy.
- Environmental monitoring – sampling, interpretation and corrective action plans
- Case studies illustrating the importance of pressurization and how differential pressure is used as a barrier for contamination.
Questions? Contact us at firstname.lastname@example.org or at 1-800-825-5343.