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Visionary Standards: Advancing Science and Regulation in Generic Ophthalmic Products
Intricacies in development opthalmic products, BE studies , challenges in generics, invitro drug release testing, qualitative (Q1) & quantitative (Q2) sameness of complex ingredients, characterisation |
FDA & CRCG |
20 Nov 2025 |
Workshop |
Free |
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Modeling and Artificial Intelligence (AI) in Generic Drug Development and Product Lifecycle Management: Regulatory Insights and Future Trends
Current thinking from FDA, EMA on AI integration in drug development, AI applications in drug development, regulatory writing, product development, predictive modelling, product & process optimization |
USFDA & CRCG |
16 Oct 2025 |
Workshop |
Free |
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Orthogonal Analytical Methods for the Characterisation of Pharmacopoeial Reference Standards
How are pharmacopoeial reference standards characterised? assigned values (or purity values) established? Case studies, structure characterisation, impurity identification, potency assignment #Reference & Working Standards,
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USP & EDQM Joint Webinar |
09 Oct 2025 |
Webinar |
Free |
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Future of Automated Environmental Monitoring in Pharma
Regulations on environmental monitoring for pharma, mapping of sampling plan and measurement processes including active air monitoring, automation possibilities, eliminating manual interventions #Environmental Monitoring,
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Particle Measuring Systems (PMS) |
14 Oct 2025 |
Webinar |
Free |
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Exploring the Expanding Uses of USP Apparatus 1 and 2
Using USP Apparatus 1 and 2 for todays testing needs for dissolution, chewable products, products with nanoparticles, poor solubility, low doses, products other than solid oral dosage forms |
LCGC & Agilent |
07 Oct 2025 |
Webinar |
Free |
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AI & Data Integrity: Navigating Compliance in the Digital Age
Artificial intelligence (AI) and data integrity in Computer System Validation (CSV), AI’s impact on data integrity and compliance, regulatory expectations, Best practices for validating AI- systems #CSV,
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KENX |
15 Oct 2025 |
Webinar |
Free |
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Advances in Gas Chromatography: A Virtual Symposium
Recent advances in GC, practical approaches to boost method development skills, Analysis of Nitrosamine Precursors, Surface Energy Analysis on Fine Powders, Non-targeted Screening of Complex Samples |
LCGC |
29 Oct 2025 |
Virtual Symposium |
Free |
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Everything You Should Know About Headspace GC
• Headspace GC, Type of samples for Headspace GC, analyte solubility, working of headspace sampling, headspace instrumentation, , optimizing parameters, calibration of headspace GC |
Chromacademy |
16 Oct 2025 |
Webinar |
Free |
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Advancing Pharmaceutical GC Method Development with Vacuum UV (VUV) Detection
Vacuum ultraviolet (VUV) detection technology, theory and operation, spectral fingerprints, impurity profiling, peak purity assessment of coeluting analytes, Uses in conjunction with FID, MS |
LCGC |
22 Oct 2025 |
Presentation |
Free |
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Controlling Analytical Variability to Justify Change and Ensure Compliance
Understanding and controlling multiple sources of variability—reagent quality, instrument performance, operator technique, sample preparation, data processing; identify, monitor, document variability #Analytical Validation,
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Peter Baker & Waters |
22 Oct 2025 |
Webinar |
Free |
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Tools for Reviewing and Managing Method Variability
Understanding and controlling sources of variability—reagent, instrument, operator, sample preparation, data processing; identifying, managing variability; risk assessments, control charts, AI support #Analytical Validation,
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Peter Baker & Waters |
11 Nov 2025 |
Webinar |
Free |
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Managing Method Variability: A Foundation for Risk-Based Change
Understanding sources of method variability—reagent, instrument, operator, sample preparation, data processing, examples, justifying changes due to shift in materials, instruments, processes #Analytical Validation,
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Peter Baker & Waters |
02 Dec 2025 |
Webinar |
Free |
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2025 EDQM Virtual Training Programme: Module 1: General methods, General chapters and General monographs
Fundamentals related to the use of the European Pharmacopoeia (Ph. Eur.), walk-through of the structure of the Ph. Eur, correct use of general monographs, dosage form monographs and general chapters |
EDQM |
01 Dec 2025 |
Webinar |
Free |
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2025 EDQM Virtual Training Programme: Module 2: Individual monographs
Individual monographs of actives, excipients, medicinal products, link between individual, general monographs and general chapters, policy for medicinal product monographs, titles, dissolution tests |
EDQM |
02 Dec 2025 |
Webinar |
Free |
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LCMS/MS Method Considerations for Nitrosamine Analysis in APIs
Challenges in retention of polar low molecular weight nitrosamines, interference from other impurities, isobaric interference from DMF, over quantification of NDMA, challenges in metformin analysis |
LCGC |
21 Oct 2025 |
Webinar |
Free |
