Quality Systems

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Articles

A risk assessment should be performed as part of the CAPA process, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates. 

The Relationship Between CAPAs and Data: What’s the Right Balance?

Christopher Burgess, PhD, is managing director, Burgess Analytical Consultancy Limited, Barnard Castle, Co Durham, UK.

How confident are you in your lab results? This paper explores this question and, by way of a worked example, provides a methodology to answer it.

Never Mind the Statistics; Just Tell Me What the Answer Is! 

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

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

The ability of artificial intelligence to process large amounts of diverse data cleanly creates more accurate reports for improved drug safety. 

Harnessing Technology to Ensure Drug Safety

Phil Borman, DSc, has served in multiple quality-related roles at GlaxoSmithKline; as of April 2021, he is senior fellow and director of product quality.

Amanda Guiraldelli Mahr is scientific affairs manager, US Pharmacopeia.

Joachim Ermer is head of Analytical Lifecycle Management Chemistry Frankfurt at Sanofi.

Stephanie Sproule is a member. of the USP M&DQ EC.

Jean-Marc Roussel is a  member of the USP M&DQ EC.

Jaime Marach is member of USP Analytical Procedure Life Cycle Joint Subcommittee.

Horacio Pappa is senior director, US Pharmacopeia.

Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.

Ongoing Analytical Procedure Performance Verification—Stage 3 of USP<1220>

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Good distribution practices ensure appropriate physical storage, distribution, and supply chain security, says Siegfried Schmitt, vice president, Technical, at Parexel.

Securing the Supply Chain with Good Distribution Practices

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

The further we pursue CGT, the more variability we need to account for in order to engineer consistency into these new products.

Designing Potency Assays for Complex Novel Modalities

Ashley Boam, MSBE, is the Director of the Office of Policy for Pharmaceutical Quality in FDA’s Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research. 

Theresa Mullin, PhD serves as CDER’s Associate Director for Strategic Initiatives and leads CDER’s International Program in FDA.

Harmonization of global regulations fosters innovation and ensures quality medicines.

Quality Assurance/Quality Control