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Hilton Philadelphia at Penn's Landing,
Philadelphia, PA
Drive Excellence in Compounding Compliance and Quality Standards
Delivering timely regulatory updates, innovative technology solutions, and industry best practices to elevate quality assurance and compliance
2026 Regulatory Updates and Compounding Solutions
USP 795, 797 & 800 — From Guidance to Execution
- Examine how compounders are operationalizing updated USP requirements across facilities, workflows, training, and documentation
- Identify common implementation gaps that create compliance risk during inspections
- Clarify when USP monograph methods meet stability-indicating expectations across compounded preparations
Inspection Readiness, Audits & 483 Intelligence
- Break down the most frequent FDA 483 observations and what they reveal about current enforcement priorities
- Learn how to interpret audit findings to drive meaningful quality improvements and avoid repeat deficiencies
- Understand FDA focus areas including environmental monitoring, documentation integrity, and aseptic technique
503A & 503B Compliance in a Shifting Landscape
- Navigate evolving regulatory expectations for both 503A and 503B facilities
- Strengthen CAPA programs, contamination control strategies, and quality oversight for outsourcing facilities
- Evaluate readiness, risks, and operational requirements for transitioning from 503A to 503B
Sterile Integrity & Ingredient Verification
- Address compliance risks tied to ingredient sourcing, sterility designation, and labeling accuracy
- Understand how dual monographs and ingredient classifications impact sterile compounding decisions
- Improve purchasing and quality controls by clarifying API vs excipient use, NDCs, and chemical grades
GLP-1s & Emerging Compounded Therapies
- Understand the regulatory landscape for compounded GLP-1s, including recent FDA decisions and enforcement trends
- Assess the impact of GLP-1 demand on compounding operations, patient access, and risk exposure
- Prepare for how emerging therapies may reshape compounding oversight and expectations
Technology, AI & New Care Models
- Explore practical applications of AI and automation to enhance accuracy, efficiency, and patient safety
- Navigate regulatory and validation considerations for digital tools in compounding environments
- Examine telepharmacy and direct-to-patient models, including compliance challenges and state-level considerations
Who Should Attend
You will benefit from the attending this event if you work in a facility that produces compounded drugs and have responsibilities or involvement in:
Quality Assurance
Quality Control
Pharmacy Operations
Owner / President / CEO
Compliance
Pharmacist in Charge
Policy & Regulatory Affairs
Legal
General Counsel
Pharmacy Services
Facilities Management
Engage a Qualified Audience of Compounding Pharmacy Professionals!
Whether you’re looking to generate quality leads, showcase thought leaders or reinforce your brand, collaborate with us to identify custom sponsorship opportunities to help you reach your business objectives.
Contact Steven Markos to learn more about sponsorship opportunities: StevenM@informaconnectls.com
Put Yourself CenterStage
Build your personal brand. Position your company as leaders. Engage your community and peers.
Join CenterStage, Informa Connect's speaker rewards program, and get access to new opportunities to speak, create content, and get published on our online platforms. Earn points and redeem them for rewards every time you speak at an event or your content is viewed on Streamly - the new business video platform, powered by Informa, for experts, by experts like you.
You'll have member access to resources, to guide you through the process and intricacies of showcasing your stories, expertise, learnings, and content across a wide range of in-person, hybrid, and virtual events.
Watch the video and click the link to find out more!
