Time: 9:00 AM to 4:30 PM
Location: US Pharmacopeial Convention
121601 Twinbrook Parkway,
Rockville, MD 20852
Register Agenda and Speaker Bios coming soon!
Workshop Objectives:
The objective of this one-day joint workshop between the United States Pharmacopeia (USP) and the Parenteral Drug Association (PDA) is to bring together regulators, manufacturers, suppliers, and scientific experts to:
- Discuss and clarify the proposed revisions to USP General Chapters 〈660〉 and 〈1660〉, including scientific rationale, scope, test approaches, and anticipated impact on qualification and lifecycle management of glass packaging systems.
- Examine current, new, and emerging topics in parenteral glass, including manufacturing performance, innovation, and sustainability considerations.
This workshop is designed to foster science-based dialogue, promote regulatory and industry alignment, and support practical, risk-based implementation strategies that can help advance patient safety, product quality, and long-term sustainability.
Participants will have the opportunity to:
- Understand the intent, scope, and technical framework of the proposed 〈660〉/〈1660〉 revisions and their alignment with contemporary glass manufacturing and control strategies, including discussion of:
- Autoclave procedures
- Glass composition testing using XRF
- Discuss implementation considerations, including management of legacy systems, supplier qualification strategies, and global regulatory expectations.
- Explore current and emerging challenges in parenteral glass manufacturing and use, such as:
- Delamination mechanisms and mitigation strategies
- Surface chemistry, durability, and chemical resistance
- Manufacturing variability, defect control, and process capability
- Review new and emerging glass technologies, including advances in:
- Glass composition
- Surface treatments and coatings
Speakers:
- United States Pharmacopeia (USP)
- Pharmacopeia Discussion Group (PDG)
- U.S. Food and Drug Administration (FDA)
- Parenteral Drug Association (PDA)
- Global glass manufacturers and industry stakeholders
Registration Fee:
- Associations / Industry Early Registration (before 4/1/2026): $750.00
- Associations / Industry Regular Registration: $850.00
- Regulatory Agencies: $100.00
- Academia / Research Institutions: $100.00
- Students: 100.00
- Event Speakers: Free
- USP Volunteers: Free
- USP Staff: Free