QA/QC

QA/QC | Regulatory Affairs

Regulatory Compliance Trends

Re-assessing outsourcing strategies for ‘new normal’ regulatory compliance.

Steve Cottrell, President, Maetrics 10.14.20

Breaking News | cGMP Manufacture | Industry News | Parenterals | QA/QC

Lonza Expands QC Testing Portfolio

Launches PyroCell MAT System for in vitro Pyrogen testing to help ensure safety of parenteral pharmaceuticals during development, manufacture and release.

Contract Pharma Staff 10.01.20

Breaking News | Industry News | QA/QC

Rx-360 Expands Audit Program

Adds remote auditing and new checklists.

Contract Pharma Staff 08.12.20

APIs | Clinical Trial Materials | Process Validation | QA/QC | Regulatory Affairs

Regis Custom Pharma

07.31.20

Drug Development | GMPs/GCPs | Information Technology | QA/QC

Solving Compliance Challenges and Beyond with Natural Language Processing

Understanding new data sources and elevating compliance to drive innovation.

Updesh Dosanjh, Practice Lead, IQVIA Vigilance Platform, IQVIA, Jane Reed, Head of Life Science Strategy, Linguamatics, an IQVIA company 06.16.20

Drug Development | Industry News | QA/QC

USP Provides Guidelines for rFC Reagent

Recombinant Factor C critical to development of vaccines and other sterile pharmaceutical products.

Contract Pharma Staff 06.01.20

cGMP Manufacture | CRO News | QA/QC

Parexel Launches COVID-19 Risk Mitigation Offering

Four-step methodology aims ensure manufacturers can safely continue manufacturing operations through the COVID-19 pandemic

Contract Pharma Staff 05.13.20

Clinical Trials | Information Technology | QA/QC

Managing Clinical Trials Amid the Coronavirus Pandemic

Patrick Hughes of CluePoints discusses the impact on clinical trials and how leveraging data may herald a long overdue paradigm shift in the industry.

Online Exclusives Kristin Brooks, Contract Pharma 04.06.20

Breaking News | Industry News | Inspections | QA/QC | Regulatory Affairs

COVID-19 Update: FDA Foreign Inspections

To postpone most foreign inspections through April, effective immediately

03.10.20

Breaking News | Industry News | Inspections | QA/QC | Regulatory Affairs

FDA Provides Update on Activities Related to Coronavirus

Says it continues to monitor the global drug supply chain by prioritizing risk-based inspections in other parts of the world

02.25.20

Breaking News | Industry News | QA/QC

ALKU Expands Services to Focus on Analytical R&D

Expands services into two groups, Pharmaceutical Quality, Validation, and Compliance, and Pharmaceutical Analytical Research and Development

02.21.20

QA/QC

Quality Management: Preserving and Perpetuating Your Record

CDMOs must ensure that their top priority be delivering the highest quality products.

Colleen Herczak, Vice President of Quality, Grand River Aseptic Manufacturing 01.28.20

Clinical Trials | Drug Development | GMPs/GCPs | Information Technology | QA/QC

Compliance Practices 2020 Predictions

Joe Rymsza of IQVIA shares insights on pharmacovigilance, safety and regulatory trends and the use of advanced technologies in 2020

Joe Rymsza , vice president, Pharmacovigilance and Regulatory Technology Solutions, IQVIA 01.13.20

Breaking News | Packaging & Tracking | QA/QC

Pelican BioThermal Achieves ISO Accreditation

Laboratories in the UK and US receive global recognition for technical capabilities and quality standards

12.12.19

Analytical Services | Industry News | QA/QC

Recipharm Launches Recipharm Analytical Solutions

Stand-alone service offers analytical services including method development, method validation, and stability program design and implementation

11.04.19

Microbiology | QA/QC

Pharma Manufacturing: Methods for Real-Time Microbiology

Vicki Barbur of Battelle discusses real-time microbiology, critical factors determining the rapid method of choice, and accessibility to new technologies

Online Exclusives Kristin Brooks, Contract Pharma 09.16.19