FDA Compounding Quality Center of Excellence: Ten Years of Regulated Outsourcing Facilities: A Decade of Progress, But More to Do – (Sept. 11th-13th) Virtual Conference
The MediZap team spent 3 days engaged in all virtual meeting topics and have created a downloadable PDF document that incorporates highlights and learnings we have gathered from this conference. Topics included: Prohibition on wholesaling under section 503B of the Federal Food, Drug, and Cosmetic Act Stakeholder Perspective: 503Bs as Partners to Providers: Benefits and Challenges Quality Throughout the Supply Chain Drug Shortages Managing State Regulatory Challenges Stakeholder Perspective: Purchasing and Forecasting: How it Works Product Complaints and Investigations Process Validation and Automation Click here for MediZap’s summarized PDF Click here to view FDA recordings directly
Act Now: Exploring Alternative Terminal Sterilization by Irradiation Methods of E-Beam and X-Ray Compared to Gamma
Check out what's new at MediZap. MediZap White Paper Act Now: Exploring Alternative Terminal Sterilization by Irradiation Methods of E-Beam and X-Ray Compared to Gamma This white paper is a call to action and instills the need for consideration in terminal sterilization by irradiation, a high-level comparison between E-Beam, X-Ray, and Gamma. Read White Paper
Attended by MediZap CEO Jonathan Bergstrom on May 19, 2023, at the Paradise Point Resort, 2023 San Diego Equality Awards, celebrating our community and honoring the inspirational leaders whose selfless work helps create a world that is healthy, just, and fully equal for all LGBTQ+ people! Our Mission Equality California brings the voices of LGBTQ+ people and allies to institutions of power in California and across the United States, striving to create a world that is healthy, just, and fully equal for all LGBTQ+ people. We advance civil rights and social justice by inspiring, advocating, and mobilizing through an inclusive...
Problem Statement: There is a gap in the combined compounding industry knowledge base with the most common API’s and excipients to the exposure to E-Beam | X-Ray forms of terminal sterilization by irradiation. This slows the movement of more compounds to this advanced form of sterilization and its increased proven potential to reduce safety risk and increase sterility assurance level (SAL); which is an ongoing current focus of regulatory bodies. Vision Statement: MediZap and SteriTek have deep subject matter expertise on this terminal sterilization technology and across the compounding industry there is a need for a database that Compounders/Manufacturers (C/M)...