Cleaning Validations Using Extraction Techniques

Cleaning validations are an essential step in the medical device development process. One of the most common methods is using extraction techniques to validate the cleanliness of a device. This webinar will provide valuable guidance on how to achieve a thorough validation of a cleaning process. Why should you attend:Medical device manufacturers have always been under […]

200+ followers. WOWWWWWW…

Hello Everyone, Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community. we are so incredibly […]

Process Development and Validation rest on the right Design of Experiments and Statistical Process Control

The application of DOE and SPC to the development, design and monitoring of manufacturing and testing requires the use of procedures. Why? It is because in a recent guidance document on Process Validation, the FDA has named the Quality Unit as being responsible in the review and interpretation of DOE and SPC studies. The Quality […]

Drug dissolution testing and establishing plasma drug levels in humans

Dissolution testing is a very important tool that determines and help understand the performance and effectiveness of oral solid dosage forms. It is significant for the field of medicine because if a drug has to be effective, it must be released first from the product form, and it should then be allowed to get dissolved […]

21 CFR Part 11 compliance requirements for software validation and SaaS/Cloud

  Software as a Service, SaaS, is a way by which applications are delivered over the Net. It provides Software as a Service using just the Internet, and hence the name. SaaS applications are known by varied names. On-demand software, hosted software, and web-based software are some of these. Where SaaS differs as a method […]

Learn any professional courses for $10 only

Want to enhance your regulatory compliance career by learning a new course? All that it costs is $10. Yes, GlobalCompliancePanel, a provider of professional trainings, is offering hundreds of high value regulatory compliance courses for a mere $10 each. Regulatory compliance learning, that vital ingredient needed for professionals in any area of regulatory compliance, is […]

Implementing ICH guidelines-compliant validation

Professionals in the field of statistical analysis need to possess clarity on understanding and interpreting statistical concepts used to investigate quantitative ICH Guidelines, such as: Analytical methods validation Procedures and acceptance criteria in calibration limits Process and Quality Control Process and quality controls ICH Q8 and Q9. The ICH tripartite-harmonized ICH Guideline on Text, which […]

Validation the complies with ICH guidelines

A clear and perceptive insight into how to understand and interpret statistical concepts used to investigate quantitative ICH Guidelines such as analytical methods validation, procedures, and acceptance criteria in calibration limits is required from professionals in the field of statistical analysis. They also need to have a proper understanding of process and quality controls, as […]