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Delivered as a Hybrid Event
June 21-22, 2022Hilton Alexandria Mark Center | Alexandria, VAkeyboard_arrow_right
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DAY 2 ✦ IN-PERSON ✦ Wed, June 22 - All Times are EST
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DAY 2 ✦ IN-PERSON ✦ Wed, June 22 - All Times are EST
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7:30am - 8:00am30 mins
General Session
Breakfast
8:00am - 8:05am5 mins
General Session
Chairperson’s Day 2 Kick-Off
8:05am - 8:50am45 mins
General Session
DOJ Address — Analysis of Enforcement Trends and Industry Oversight for Drug Compounding
- Raquel Toledo - Trial Attorney, U.S. Department of Justice
8:50am - 9:35am45 mins
General Session
Using Rapid Microbial Methods for Safe, Same-Day Product Release
- Lori Daane, PhD - Director of Scientific Affairs, Pharmaceutical Microbiology, BioMerieux
9:35am - 10:05am30 mins
General Session
Networking and Refreshment Break
10:05am - 10:50am45 mins
General Session
Introduction of Risk- & Science-Based Limits for USP <800>’s Hazardous Drugs
- Seth DePasquale - Owner and Pharmacist in Charge, BET Pharm
10:50am - 11:35am45 mins
General Session
How Smart Microbial Control Contributes to Cost Avoidance — A Contamination Event Case Study
- Jonathan Kallay - Senior Technology and Market Development Manager, Charles River Laboratories
11:35am - 12:35pm60 mins
General Session
Networking Luncheon: Diversity, Equity and Inclusion Highlight
CUSTOMIZE YOUR LEARNING EXPERIENCE ★ CHOOSE BETWEEN 2 CONCURRENT TRACK OPTIONS
12:35pm - 1:20pm45 mins
Track 503A
Incorporating USP Standards into Compounding Practices
- Helen McKnight, PharmD, MBA, BCSCP - Director of Pharmacy, Princeton Baptist Medical Center
12:35pm - 1:20pm45 mins
Track 503B
Enhance Your Quality Management Systems — Best Practices and Brainstorming
- Paul Baker, PharmD, BCSCP - Compounding Compliance Coordinator, Massachusetts General Hospital
CUSTOMIZE YOUR LEARNING EXPERIENCE ★ CHOOSE BETWEEN 2 CONCURRENT TRACK OPTIONS
1:20pm - 2:05pm45 mins
Track 503A
Translating Pharmacogenomics into Clinical Decisions
- Cari A. Lalande, PharmD, RPh - Founder and CEO, Health By Genetics
1:20pm - 2:05pm45 mins
Track 503B
Reinventing your Aseptic Processing with Flexible Robotic Manufacturing
- Brittany Hoff - Brand Integration Manager, AST
2:05pm - 2:35pm30 mins
Networking and Refreshment Break
CHOOSE FROM TWO TRACK OPTIONS (A OR B)
2:35pm - 3:20pm45 mins
Track 503A
Comparing Key Players — Evaluating the Evolving Roles of the FDA, State Boards and Industry Perspectives on Compliance
- Jenni Wai, RPh, MBA - Chief Pharmacist, State of Ohio BOP
- Michael Blaire - Vice President, Government & Regulatory Affairs; Member (2015-2020), Wedgewood Pharmacy; Arizona State Board of Pharmacy
2:35pm - 3:20pm45 mins
Track 503B
Meeting Quality Requirements — Quality Assurance Means Quality Built In
- Amy Summers, PharmD, BCSCP - Consultant, Restore Health Consulting
CHOOSE FROM TWO TRACK OPTIONS (A OR B)
3:20pm - 4:05pm45 mins
Track 503A
Managing a 503A Environmental Monitoring Program to Stand Up to Inspection
- David Melton, PharmD, BCSCP - Pharmacist Specialist Compounding Compliance, Department of Pharmacy, University of Michigan
3:20pm - 4:05pm45 mins
Track 503B
Producing Sealed Vials to Comply with Proposed cGMP Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B
- Amy Summers, PharmD, BCSCP - Consultant, Restore Health Consulting
- Doral (Neal) Higgins - Consultant Program Manager, Commercial Technology Development-Pharmaceutical Processing, West Pharmaceutical Services, Inc.
4:05pm - 4:15pm10 mins
Closing Remarks
- Elise Wyatt - Conference Producer, Informa Connect