QA/QC

Information Technology | QA/QC | Regulatory Affairs

The Importance of Data Integrity Risk Assessment

Executing Data Integrity Risk Assessments for systems that generate and store both paper (manual)-based systems as well as computer-based and hybrid systems.

Paul Mason, Ph.D., Lachman Consultants 06.07.21

cGMP Manufacture | QA/QC

Ensuring Pharma Manufacturing Quality

How today’s life sciences manufacturers can effectively monitor processes, integrate with sub-contractors and align with regulatory reporting requirements.

Online Exclusives Kristin Brooks, Contract Pharma 04.14.21

Clinical Trials | Drug Development | QA/QC

RBQM Comes of Age: COVID as a Catalyst for Change

Clinical trial conduct has undergone a fundamental shift over the last year – and things will never be the same again.

Online Exclusives Kristin Brooks, Managing Editor 04.01.21

Enteris BioPharma: Custom Solutions – From Bench to Market

CDMO operations are housed within a 32,000-square-foot, FDA-inspected and cGMP-compliant facility in northern New Jersey.

Sponsored released by Enteris BioPharma 04.01.21

CDMO Cognate BioServices Teams Up with L7 Informatics

To implement L7|ESP for integrated manufacturing and lab operations.

Contract Pharma Staff 12.16.20

Samsung Biologics Adopts Veeva Vault QMS to Unify Quality Management

CDMO is managing quality processes and content for greater visibility and compliance across global manufacturing.

Contract Pharma Staff 12.16.20

Breaking News | Facilities | Industry News | QA/QC

The Wasdell Group Earns ISO 13485 Certification

The newly certified facility will provide a base for PPFL services in Ireland.

Contract Pharma Staff 12.14.20

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

UK’s VMIC to Implement Lonza’s MODA-EM

To digitize its Microbiology Quality Control operations.

Contract Pharma Staff 12.08.20

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

Regis Custom Pharma

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Deanna Rentner, Marketing Coordinator 11.12.20

Breaking News | Facilities | Industry News | QA/QC

Wuxi Griffin Completes Investment in New QC Lab and Storage Facility

Offers fully equipped microbiology and analytical testing lab for bulk and final product testing.

Contract Pharma Staff 10.26.20

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

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