Day 1 - ET (Eastern Time, GMT-05:00)
- Explain the process for creating or revising a USP standard
- Describe the background of the revisions for USP <795> and USP <797>
- Identify key aspects of the latest revisions to USP <795> and USP <797>
- Lauren Pearson, Pharm.D., MBA - Senior Scientist I, Personalized Medicines, US Pharmacopeia
- Gain insight on how independent and national compounding companies can prepare for inspections
- Preparing for on-site and remote inspections
- Handling 483s once you are inspected
- Ross Caputo, PhD - President, Eagle Analytical
- Dorcas Ann Taylor, PharmD, JD - CDR, U.S. Public Health Service Team Lead, Regulatory Counsel, Division of Compounding Policy and Outreach, Branch 5, Office of Compounding Quality and Compliance, Office of Compliance, FDA/CDER
Gain insights on the challenges with compounded medications not covered by insurance/Medicare
Explore key strategies in liaising with FDA and state boards
- Melissa Stefko - Senior Vice President, Regulatory Affairs, Wells Pharmacy Network
- Expectations of USP 795 for non-sterile compounding pharmacies
- Which unsanitary conditions documents are applicable to 503As
- Ted Toufas, BS, PharmD, RPh - Pharmacist-in-Charge, Acton Pharmacy
- Victor Hill - Director of Quality, Vios Compounding
Explore the strategies in managing patient care amidst both drug shortages and 503B product scarcities, while gaining insights on the essential methodologies 503A compounding pharmacies can employ to effectively vet their supplies, mitigating potential risks within the supply chain.
- Viral Jani - Director of Pharmacy Operations, Town & Country Compounding
With the recent supply chain issues and drug shortages, discuss:
- How compounding pharmacies will be working to fill those gaps
- What 503Bs are currently doing in the interim to mitigate shortages?
- FDA considerations on bulk list revisions due to drug shortage
- Navigating drug shortages due to quality issues from 503Bs
- Aseptic process manipulation
- Shipping and validation for compounds
- Qualifying vendors for API and critical components
- 503 Bulk Lists
- Trupti Sindhi - Senior Managing Pharmacist, Operations, QuVa Pharma
- Sophia Flores - Director of Manufacturing Operations, QuVa Pharma
- Jon Kallay - Senior Technology and Market Development Manager, Charles River
- Testing requirements for sterile and non-sterile compounding
- Strategies for identifying and mitigating inconsistencies in 503A products
- Jules D'Souza - 503A Quality Director, Empower Pharmacy
- Katrina Harper - Director of Clinical Education, AIS Healthcare
- Discuss the challenges surrounding USP 800 and the yet to be revised NIOSH list
- Stay up to date with documentation requirements regarding environmental monitoring.
- Keeping up with environmental monitoring documentation requirements.
- Kathleen Kane - Assistant Director of Pharmacy, Compounding Integrity and Compounding Regulatory Compliance, UChicago Medicine
Engage in discussions on FDA 483 trends, the progression of the 503B market, and strategic measures to stay ahead of the curve in this industry
QUVA Pharma is a large compound pharmacy that performs a vast number of endotoxin tests per year. The number of tests monthly has been just under 2,000 samples, which equates to 24,000 tests a year. With sample volume projected to further increase, product test costs, variability, reproducibility as well as sustainability become paramount. Given that current cartridge-based testing was seen to be lagging in many of these attributes, studies were undertaken to explore the feasibility of switching to recombinant methods. The data generated has shown improvements on all these parameters and therefore an extensive validation was performed by bracketing like sample concentrations. Today, most samples have been switched to recombinant tests. This presentation will detail this journey in detail.