Expert Forums
Beyond Sample Tracking – LIMS as the Backbone of Laboratory Data Integrity
Beyond Sample Tracking – LIMS as the Backbone of Laboratory Data IntegritySponsorship opportunities are available for this event. Please contact Dean Graimes or Jeroen Reiniers for more information. Event Overview Laboratory Information Management Systems (LIMS) have...
CMC: A Developmental Approach to Ensure Drug Quality – from Small-Molecule Drugs to Biotherapeutics
CMC: A Developmental Approach to Ensure Drug Quality - from Small-Molecule Drugs to BiotherapeuticsJoin our experts, and by attending this forum, you will: Enhance your understanding of the role of CMC (Chemistry, Manufacturing and Control) in drug development and...
Understanding The Difference Between Small-Molecule Drugs And Biotherapeutics
Understanding The Difference Between Small-Molecule Drugs And BiotherapeuticsJoin our experts, and by attending this forum, you will: Enhance your comprehension of the fundamental differences between small-molecule drugs and biologics, including monoclonal antibodies...
Best Practices for Updating Analytical Procedures in Drug Development and Manufacturing
Best Practices for Updating Analytical Procedures in Drug Development and ManufacturingJoin our experts, and by attending this forum, you will: Learn the regulatory expectations for replacing or updating analytical procedures during drug development and manufacturing...
Overcoming key challenges in understanding and implementing guideline ICH Q14 for Analytical Procedure Development
Overcoming key challenges in understanding and implementing guideline ICH Q14 for Analytical Procedure DevelopmentJoin our experts, and by attending this forum, you will: Benefit from in-depth knowledge sharing and insightful discussions for a deeper understanding of...
Setting Biopharmaceutical Specifications: Navigating Regulatory Requirements in Accordance with ICH Q6B
Setting Biopharmaceutical Specifications: Navigating Regulatory Requirements in Accordance with ICH Q6BJoin our experts, and by attending this forum, you will: Gain in-depth knowledge and engage in insightful discussions to deepen your understanding of ICH Q6B. Learn...
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Webinars
Capillary Electrophoresis (CE) versus quantitative Polymerase Chain Reaction (qPCR) for direct quantification of intact adenovirus particles
Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics
Practical Examples and Regulatory Expectations for the Validation of Biotechnological Analytical Methods – Linearity Testing, Total Error Approach
ICH Q2 Revision 2 and Method Development and Validation Objectives (Analytical Target Profile)
Analytical Quality by Design: from Quality Target Product Profile to the Analytical Target Profile
Advertisement Contributed by Lukas MoglerPrincipal Scientist, Forensic Chemistry, Drug Product Services, LonzaConnectAdvertisementAdvertisement[lwp_divi_breadcrumbs _builder_version="4.27.4" _module_preset="default" hover_enabled="0"...
Patient-Centric Commercial Specifications for Biotherapeutic Products, Strategies and Case studies
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Articles
ICH Q14: Guideline Overview for Analytical Procedure Lifecycle Management
AdvertisementThe ICH Q14 guideline, formally part of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), represents a step forward in ensuring that analytical methods for pharmaceuticals are scientifically...
Quality Control in the (Bio)Pharmaceutical Industry: Safeguarding Medicines for Global Health
AdvertisementIn the pharmaceutical industry, the stakes for producing high-quality products are unparalleled. Medicines, whether traditional small molecules or advanced biologics, can save lives, prevent diseases, and improve quality of life. However, rigorous Quality...
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