Early Bird Registration and Hotel Block Available Until
APRIL 10
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Workshops
WorkshopsMay 1, 9am - 4pm
Excipient Supplier Qualification - Deep dive into qualification for supply resiliency
May 1, 9am - 12pm
This workshop will take a deep dive into excipient supplier qualification with a focus on achieving resiliency of excipient supply. Supplier qualification guidances will be reviewed. Points to consider for risk assessment and supplier qualification stages will be discussed in detail. Recent examples of counterfeit and adulterated excipients will be shared followed by workshop participant brainstorming session on creative solutions for preventing counterfeit and adulterated excipients from being used to manufacture medicinal products.
Key new IPEC Papers and Guides: What you need to know!
May 1, 1pm - 4pm
This half-day workshop will focus on a review of recently published and pending IPEC Position Papers and Guides. The interactive workshop will be designed with breakout sessions to facilitate audience participation and feedback. It will also include group discussion on ideas for future improvements and/or needs.
The following new and revised guides will be covered during this workshop:
- IPEC/PQG The Joint Good Manufacturing Practices Guide for Pharmaceutical Excipients (V5, Sept 2022)
- IPEC-Americas Good Manufacturing Practices (NSF/IPEC/ANSI 363) Audit Guide for Pharmaceutical Excipients (NEW Jan 2023)
- IPEC Excipient Information Package User Guide and Template, Part IV: Sustainability (NEW March 2023)
- IPEC Significant Change Guide for Pharmaceutical Excipients (V5, Feb 2023)
- IPEC Stability Guide for Pharmaceutical Excipients (V2, Nov 2022)
- IPEC Certificate of Analysis Guide for Pharmaceutical Excipients (V2, Nov 2022)
- Questionnaire for Excipient Nitrosamines Risk Evaluation (Feb 2023)
Registration Pricing
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