It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.

Steps Towards Demystifying Risk-Based Decision Making

Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Computer Validation Confirms Evidence

Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.

Digitalization of QbD Risk Assessments

Topic

Articles

27 drugs within Medicare will face penalties for having their prices raised faster than the rate of inflation. 

First Drugs Hit by Inflation Reduction Act Price Controls

Mike Wilson, QA/QC Strategy, Waters Corporation

Technological advances hold promise for mitigating human error in the pharmaceutical industry, especially in quality assurance/quality control, by reducing the incidence of, and risk associated with, mistakes.

Mitigating Human Error and Supporting Compliance with Smart Technology

Paul Van Tilborg is director of analytical sciences at Ardena.

A phase-appropriate analytical development strategy is crucial, especially for complex (formulated) drug substances.

Phase-appropriate Analytical Methodology

David R. Schoneker is chairman of the International Pharmaceutical Excipients Council of the Americas. He also is director of global regulatory affairs at Colorcon.

The impact of the potential ban would have serious consequences for the availability of many drugs for European patients.

How Banning Titanium Dioxide Might Impact Pharma

Manual aseptic operations make quality practices necessary in the manufacturing of compounded drugs.

Quality Considerations for the Manufacture of Compounded Drugs

Pankaj Bhardwaj serves as a senior product manager Datafoundry for DF mSignal AI.

Ryanka Chauhan serves as a product manager at Datafoundry for DF mSignal AI.

By leveraging certain strategies, organizations can effectively close data gaps and achieve more accurate and effective machine learning models in pharmacovigilance.


Overcoming Data Gaps in Pharmacovigilance

Cliff Campbell is senior consultant at KPC.

Quality quartets support an integrated and stable combination of
commissioning and qualification and quality risk management processes.

Points to Consider for Knowledge Management Acceleration

Feliza Mirasol is the science editor for 

FDA has approved Acadia Pharmaceuticlas’ Daybue (trofinetide), the first treatment for Rett syndrome, a rare genetic disorder.

Acadia Pharmaceuticals Receives FDA Approval for First Treatment for Rare Genetic Disorder

FDA has approved Pfizer’s ZAVZPRET (zavegepant), a new nasal spray treatment for migraine. 

FDA Approves Pfizer’s New Migraine Nasal Spray

FDA is seeking $7.2 billion to enhance food safety and advance medical product availability. 

Quality Systems

Steps Towards Demystifying Risk-Based Decision Making

Computer Validation Confirms Evidence

Digitalization of QbD Risk Assessments