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

James Vesper, PhD, MPH  is director, Learning Solutions at ValSource,
Jvesper@valsource.com.

Amanda McFarland, MSc is senior QRM and Microbiology consultant at ValSource.

Articles

Using the four-phased method to assess QRM can ensure continual improvement and that regulatory requirements are met.

A Four-Phased Approach for Evaluating a Quality Risk Management Activity

All aspects of a drug’s lifecycle should be considered when evaluating risk assessment for elemental impurities.

Impurities Testing of Drug Products

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

An increase in applications for gene therapies is putting stress on FDA’s resources.

FDA Eyes New Strategies to Spur Gene Therapy Development

Suzanne Shelley is contibuting editor to 

Makers of specialty biologics, gene therapies, and other personalized medicines are working to identify and reduce potential supply chain risks both upstream and downstream.

Reducing Vulnerabilities in Upstream and Downstream Supply Chains

Mike Hennessy Jr. is the President and CEO of 

COVID-19 has raised the specter of pandemic planning and the question of what can be done now to prevent future disaster.

Governance of  Future Pandemics

Feliza Mirasol is the science editor for 

Sandoz’s marketing authorization applications for a proposed biosimilar to denosumab are supported by a comprehensive analytical and clinical data package.

EMA Accepts MAAs from Sandoz for Proposed Denosumab Biosimilar

The guidance describes FDA’s current recommendations regarding adjusting for covariates in statistical analysis of randomized clinical trials.

FDA Releases Final Guidance on Adjusting for Covariates in Randomized Clinical Trials 

Myrna Wilson, director, Global Marketing, Strategic Growth and Technical Sales, Pharmaceutical Ingredients, Univar Solutions, discusses the state of the biopharma supply chain, movements in the patent industry, and more.

Investigating the Pharmaceutical Ingredients Industry with Myrna Wilson (DCAT Week 2023)

Challenges to approval decisions have prompted FDA officials to reexamine of the role and composition of the agency’s many advisory committees and to explore options for change.

FDA Eyes Advisory Committee Reform to Enhance Credibility

FDA has approved the first topical gene therapy product for treating wounds in patients with dystrophic epidermolysis bullosa.

Quality Systems

Steps Towards Demystifying Risk-Based Decision Making

Computer Validation Confirms Evidence

Digitalization of QbD Risk Assessments