QA/QC

Inspections | QA/QC | Regulatory Affairs

FDA Inspection Trends Update

Insulate yourself from risk to achieve success in your FDA inspections.

Ben Locwin, Contributing Writer 05.02.22

Clinical Trials | QA/QC | Regulatory Affairs

Conducting Clinical Trials During the Pandemic: What Did We Learn?

Key takeaways from MHRA's Good Clinical Practice Symposium.

David S. O’Connor, Senior Director, Lachman Consultants 04.08.22

Information Technology | QA/QC

5 Key Characteristics of a Next Generation QMS Solution

Pharmaceutical companies must modernize their QMS to provide equal or greater value in today’s world of digital tools and information.

Kari Miller, QMS Regulatory and Product Management Leader, Global Tech Solutions, IQVIA 04.04.22

Information Technology | QA/QC

Achieving Quality Maturity: 5 Key Characteristics of a Next Generation QMS Solution

Pharmaceutical companies must modernize their QMS to provide equal or greater value in today’s world of digital tools and information.

Kari Miller, QMS Regulatory and Product Management Leader, Global Tech Solutions, IQVIA 03.28.22

Information Technology | QA/QC

Advancing Quality Transformation

Best practices for generics manufacturers and CDMOs.

Ashley Wentworth, Director, Vault Quality, Veeva Systems 02.01.22

Breaking News | Industry News | Inspections | QA/QC

WuXi STA Passes First U.S. FDA PAI at Waigaoqiao Site

Included manufacturing facility, equipment, labs, quality management system, tablet production, material handling, computer control systems, and data integrity.

01.04.22

Clinical Trials | Drug Development | QA/QC | Regulatory Affairs

Pharmacovigilance: Improving Public Health

A look into modern pharmacovigilance, regulatory role in drug safety, and public health and ADR reporting.

John Buchan, pharmasol 11.23.21

QA/QC

Three Tips for Navigating Post-Approval Pharmacovigilance

Seamlessly transition from regulatory reporting to post-approval safety surveillance in today’s market.

Emmanuel Belabe, ArisGlobal and Nina Patel Lahanis, Eversana 10.06.21

Analytical Services | QA/QC | Solid Dosage/Creams/Ointments

Fewer Vendors, Easier to Ship On-Time

Another tool to defeat supply chain problems.

Emil W. Ciurczak, Contributing Editor 10.06.21

cGMP Manufacture | Drug Development | QA/QC

Three Tips for Navigating Post-Approval Pharmacovigilance

Seamlessly transition from regulatory reporting to post-approval safety surveillance in today’s market.

Emmanuel Belabe, Associate Vice President, Safety Product Management, ArisGlobal, Nina Patel Lahanis, Associate Vice President, Safety Science, EVERSANA 09.08.21

APIs | QA/QC | Validation

Microbiological Testing Considerations for Pharmaceutical Products

Microbiological testing is a critical component to ensuring the quality and safety of pharmaceutical products. Explore more in this webinar on August 26.

07.26.21

Bioanalytical Services | Biologics, Proteins, Vaccines | Filtration & Purification | QA/QC | Reader Showcase

MOBILion Launches MOBIE HRIM for Biotherapeutic Drug Development

Designed to address characterization challenges during biopharmaceutical drug development and quality monitoring.

07.21.21

Breaking News | Industry News | QA/QC | Regulatory Affairs | Supply Chain

United States Pharmacopeia Acquires Pharmatech Associates

Expanded offerings will help regulated life science companies strengthen the supply chain for safe, quality medicines.

07.09.21

APIs | Breaking News | GMPs/GCPs | Industry News | QA/QC

Purisys Obtains Two Global ISO Certifications

Now certified for ISO 17025 for Testing and Calibration Laboratories and ISO 17034 for Reference Material Producers.

07.08.21

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