QA/QC

Chime Biologics Receives Commercial Manufacturing License

GMP commercial manufacturing license authorized by the China's NMPA demonstrates capabilities in large scale commercial production.

08.02.22

QA/QC | Regulatory Affairs

Automation Is Key to Meeting Demands in Pharmacovigilance

To handle the spike in safety reports and improve general efficiencies with adverse event reporting, the industry is turning to newer technologies.

Bruce Palsulich, Vice President of Product Strategy, Oracle Health Sciences 08.01.22

QA/QC | Regulatory Affairs

Responding to Consumer Complaints While Working with CMOs

All manufacturers face questions on how to respond to consumer complaints when working with a contract manufacturing organization.

Online Exclusives Ricki Chase & Carrie Colella, Lachman Consultant Services, Inc. 07.19.22

Selkirk Pharma Appoints New Head of Quality

Sandra Lueken has assumed the role of Vice President, Head of Quality & Regulatory Affairs.

06.09.22

QA/QC | Regulatory Affairs

Be Safer by Doing Less: The Future of Zero Touch AE Case Processing

AI & NLP Technology are critical to overcoming current adverse event processing challenges.

Updesh Dosanjh, Practice Leader, Pharmacovigilance Technology Solutions, IQVIA 06.07.22

Information Technology | QA/QC | Regulatory Affairs

Data Governance for Outsourced Facilities Management Services

Data integrity is a growing and mainstream concern within the pharmaceutical industry.

Scott Deckebach, Director & Patrick Day, Principal Consultant, Lachman Consultants 06.07.22

QA/QC | Regulatory Affairs

QSR – ISO Harmonization

All things being equal, they are not—a deeper dive.

Ricki Chase, Vice President, Lachman Consultants 06.03.22

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