Webinar: Preparing for USP 797 and 800 - No Time to Rest
June 14, 2018
1:00 - 2:00 PM EDT
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.
Join this webinar to learn about:
- 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.
Erin Higgins, MS, CIH, CSP, Senior Scientist at EH&E, has significant expertise in USP 797 and 800 compliance, providing support to healthcare pharmacies through compliance gap assessments, feasibility studies and compliance strategies for healthcare systems, development of facility and engineering controls design and construction standards, and development and implementation of comprehensive risk-based environmental monitoring programs. In addition, Erin has provided site management for contaminant control and qualifying environmental conditions during and following construction efforts, and interfaces with regulatory agencies on behalf of pharmacies.
Questions before the webinar? Contact Erin at firstname.lastname@example.org or at 1-800-825-5343.