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Watch our on-demand webinars:
Nitrosamines - New Requirements to Evaluate Contamination Risks
The Emprove® Program: an introduction focussing on the Emprove® Suite and Emprove® Chemicals content
New developments of excipient regulations in China
Extractables profiles for chromatography resins - adapted approach of upcoming USP <665>
Process equipment characterization – how standardized extractables data support E&L risk assessment
Challenges using Multiple Single-use Systems: Functionality versus Extractables and Leachables
BioPhorum Raw Materials Risk Assessments
New PDA/IPEC Technical Report on excipient risk assessment - insights for drug product manufacturers
Identifying Appropriate-Quality Pharmaceutical Raw Materials in an Evolving Regulatory Environment
Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and Tomorrow
Risk-Based Approach to Evaluate Nitrosamines and Elemental Impurities from Single-Use Components
Is USP <88>, Class VI Animal Bioreactivity Testing necessary for Plastics used in Manufacturing?
Regulatory Talks: Finalization of USP <665>
Risk-Based Qualification of X-Ray Sterilization for Single-Use Systems
The Future of Pharma- and Biopharmaceutical Audits
Regulatory Considerations Including Extractables & Leachables for Single-Use Manufacturing