Good Identification Practices for Organic Extractables and Leachables Via Mass Spectrometry
Ensuring the safety and efficacy of pharmaceutical products requires the accurate identification of organic extractables and leachables....
Archives: Courses
Benefits of Premarket and Postmarket Particulate Testing of Cardiovascular Devices
Incorporating particulate testing into the development plans of medical devices, particularly cardiovascular devices, is crucial for ensuring...
DISINFECTION VALIDATION: How to Classify and Validate Your Medical Device Disinfection Process
Reprocessing reusable medical devices involves cleaning, disinfecting, and sterilizing them to ensure they are safe and effective...
Good Identification Practices For Organic Extractables & Leachables Via Mass Spectrometry
Ensuring the safety and efficacy of pharmaceutical products requires the accurate identification of organic extractables and leachables....
The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products: Some Fallacies Addressed
When selecting and qualifying the primary packaging for lyophilized drug products, an essential question arises: How comprehensive...
Establishing Bioburden Alert and Action Levels
In the realm of bioburden, sterilization, and environmental testing, national and international standards play a crucial role...
Meeting the Requirements of 10.4 of MDR How to Address CMRs
Ensuring compliance with the Medical Device Regulation (MDR) requires a thorough evaluation of medical devices for the...
Animal Testing
Traditionally, animals have been used as test subjects during drug development studies to reliably detect the toxic...
Challenges in Design Development – Why Design Control Makes Sense
The journey from a novel idea for a new medical product to its commercial realization involves significant...
Developing a Quality System on a Budget
Developing a robust quality system is fundamental to ensuring that an organization’s products or services are safe,...
GMPs for Early Stage Development Projects
Good Manufacturing Practices (GMPs) should be implemented during the later stages of clinical development, where the final...
Implementing Risk Managed Supplier Quality
A risk-managed approach to the global supply chain is more important than ever for life science manufacturers....
Internal Audit Be Ready for FDA Inspections Hope is not a Strategy
Life science companies recognize that the FDA inspection process is a cornerstone of ensuring the safety and...
IVDR Regulation for Medical Device Directive in EU: Impact Assessment of Revision of the Regulatory Framework for MDD in EU
The existing regulatory framework for medical devices, which has been in place for 20 years, has recently...
Outsource Quality and Regulatory Agencies: Right-Sizing Need and Cost
Small or emerging life science organizations often face the dilemma of when to hire Quality and Regulatory...
US Food and Drug Administration Regulatory Pathways
Over the past five years, the medical device industry has witnessed an explosion of new and innovative...
Microbiological Control in a Pharmaceutical Manufacturing Environment
This webinar will focus on the evaluation of microbiological and environmental monitoring data, highlighting what constitutes significant...
Considerations for Third Party Reprocessing of Single-Use Medical Devices
Reusing single-use devices that have been safely reprocessed by third-party reprocessors can enable healthcare providers to maintain...
MPO Packaging Validations – A Look at Current and Future State Testing
This webinar will explore the significant changes implemented with the release of the Medical Device Regulation (MDR)...
Guidance for Cleaning, Disinfection and Sterilization of Reusable Medical Devices
All reusable medical devices must include specific instructions for cleaning, disinfecting, and/or sterilization to ensure patient safety...