Quality Systems

Kari Miller is senior director, Product Management, QMS, IQVIA.

Articles

Eradicating paper-based workflows and standalone solutions operating in isolation provides a good starting point to update quality management processes.

Revitalizing Quality Management Processes through Digitalization

Kate Coleman is Principal Quality and Compliance Consultant with Arriello Ireland.

The ICH Q9 revision clarifies QRM implementation for the pharmaceutical industry and expands descriptions of methodology, formality, and risk-based decision making to provide the industry with a solid base from which to build their own QRM programs.

The ICH Q9 Revision and a Renewed Focus on Quality Risk Management Fundamentals 

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

Final product inspection results should be included as part of the batch release documentation, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Final Product Inspection: Making the Most of Your Processes

Feliza Mirasol is the science editor for 

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, discusses the differences in how E&L study design should be approached based on whether the study  is following ISO or USP standards. 

Discussing E&L Study Design Between ISO and USP (AAPS PharmSci 360) 

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

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Videos

Pharmaceutical Technology Europe® spoke with Joren van der Horst from Luo Automation, a Dutch company focused on automated visual inspection solutions, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

Making Visual Inspection Accessible with Luo Automation at CPHI Barcelona

H. Gregg Claycamp, MS, PhD, is a Risk and Decision Analysis Consultant, hgclaycamp@gmail.com.

More attention should be given to how expert opinions and judgments are elicited for reducing uncertainty in quality risk management and risk-based decision making. 

Elicitation of Expert Knowledge and Probabilities for Controlling Subjectivity in Risk-Based Decision Making

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

There are key elements that should be covered when dealing with third-party auditors, according to Siegfried Schmitt, vice president, Technical, at Parexel. 

Using a Third Party to Perform Audits

Podcasts

In this episode of the Drug Solutions Podcast, industry experts discuss the challenges and advantages of the digitalization trend in the biopharma industry, with particular emphasis on the impacts to biomanufacturing.

Drug Solutions Podcast: Digital Transformation in the Biopharma Industry

Kent Malmros is senior director of training at Veeva Systems. He has spent the majority of his career delivering technology-enabled training solutions to life-sciences companies and has held leadership positions at companies that include AdMed, ClearPoint (Red Nucleus), and UL EduNeering (UL).

Companies can benefit from developing a single programmatic approach to a GxP training matrix.

Quality's Unsung Hero: The GxP Training Matrix

Dr. Nikunj Patel is a senior director of PBPK Consultancy Services in the Simcyp division of Certara. Nikunj helps clients with advanced PBPK modeling to expedite internal decision making, support biowaivers via virtual bioequivalence assessments, and develop model-informed regulatory strategies for novel products, generic formulations, scale-up and post-approval changes (SUPAC), and justification of dissolution specifications. He has more than more 13 years’ experience in computer-aided drug design and PKPD modeling, including 10+ years’ experience focusing on PBPK modeling.

Ellen Leinfuss is senior vice president and chief commercial officer for Certara’s Simcyp Division. Simcyp is the global leader in mechanistic modeling, employing its Simcyp Simulator physiologically based pharmacokinetic (PBPK) and quantitative systems pharmacology (QSP) immunogenicity, immuno-oncology, vaccine, and gene therapy modeling and simulation platforms. Ellen has worked for Certara for eight years, serving for several years as chief marketing officer for the corporation. She has a BA in chemistry and an MBA in marketing.

Model informed formulation development uses in-silico modeling and simulation to identify and/or refine promising formulations faster and cheaper, support formulation strategy and increasingly, demonstrate virtual bioequivalence and obtain biowaivers.

Quality Assurance/Quality Control