Quality Systems

Cliff Campbell is senior consultant at KPC.

Articles

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

Points to Consider for Knowledge Management Acceleration

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

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 the editorial director of 

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.

Convergence in the Global Regulatory Village

Shifting guidance and the growing prominence of computer software assurance exemplify the state of computer software validation.

The Punctuated  Evolution of Computer Software Validation

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

Shiri Hechter is senior lab operations manager for Nelson Laboratories

Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Shiri Hechter, senior lab operations manager for Nelson Laboratories, provide a simple approach to validating analytical methods.

Considerations for Method Validation

Editor of Pharmaceutical Technology Europe

In light of increasingly stringent sustainability requirements, bio/pharma companies need to make sure they formulate effective ESG strategies.

Setting Goals for Sustainability

A CCS provides significant benefits to the industry and helps with holistically understanding contamination controls, says Siegfried Schmitt, vice president, Technical at Parexel. 

Quality Assurance/Quality Control