QA/QC
-
QA/QC | Regulatory Affairs
Are We Embracing FDA’s Messages?
FDA guidance on analytical procedures and methods validation for drugs and biologics.Anthony J. DeStefano, Ph.D. and Tom Kester 03.06.19
-
Breaking News | Industry News | Information Technology | Inspections | QA/QC | Regulatory Affairs | Validation
Top Global Pharma Company to Implement ValGenesis' VLMS
Paperless validation system aims to harmonize and standardize the validation process across all its global sites02.12.19
-
Breaking News | Clinical Trials | Industry News | QA/QC
WCG, Prudentia Enter Pharmacovigilance Alliance
Aims to deliver a comprehensive solution aimed at enhancing the quality, safety and regulatory compliance of adverse event monitoring in drug development01.29.19
-
QA/QC
Three Ways Quality Can Impact a Business’s Bottom Line
The Quality function today is tasked with helping to improve overall company performanceStephen McCarthy, Vice President of Digital Innovation at Sparta Systems 12.05.18
-
QA/QC | Serialization | Supply Chain
Don’t Just Tick the Box, Think Outside Of It
How a quality-first approach to serialization can deliver long-term value beyond compliance.Martin Van Trieste, CEO, Civica Rx and Board Member, rfxcel 11.13.18
-
Aseptic Processing | Formulation Development | Information Technology | Logistics | QA/QC
-
APIs | Breaking News | Cytotoxics and High Potency Manufacturing | Industry News | Inspections | QA/QC | Regulatory Affairs
Recipharm Audit Results in Licence Restriction
Five non-critical highly potent products from the Ashton-u-Lyne, UK site suspended due to potential cross contamination risk10.25.18
-
Breaking News | Industry News | QA/QC
USP Launches Impurities for Development Program
Aims to help manufacturers meet quality standards and regulatory requirements to control impurities10.10.18
-
Logistics | Process Validation | QA/QC
Nulogy Launches Quality & Compliance Solution
Capabilities provided to contract packagers are purpose-designed for compliance and GMP compatible and unique to the marketOnline Exclusives Betsy Louda, Associate Editor 10.04.18
-
Facilities | Inspections | QA/QC | Regulatory Affairs
Are Indian Generic Firms Improving Compliance?
Indian firms take the generics battle to U.S. turf.Online Exclusives S. Harachand, Contributing Editor 08.09.18
-
Bio News | Biologics, Proteins, Vaccines | QA/QC
Avalon GloboCare Forms Strategic CAR-T Pact
Aims to co-develop bio-production and standardization procedures for CAR-T therapy in accordance with standards08.07.18
-
QA/QC | Regulatory Affairs
Data Integrity Awareness in Pharma
Most data integrity violations are just a result of simple lack of knowledge, negligence, or even a wrong management strategyVideos
-
Information Technology | QA/QC | Regulatory Affairs
Top 5 Misconceptions About Data Integrity
Ron Tetzlaff of PAREXEL Consulting reveals the top five misconceptions management has about data integrityVideos
-
CRO News | Industry News | Promotions & Moves | QA/QC
TFS International Appoints Quality Assurance EVP
Dr Suzanne Pavon brings over 20 years’ global experience in the CRO, biotechnology and pharmaceutical industries06.20.18
-
QA/QC | Regulatory Affairs
The Outsourcing Balancing Act
Achieving the best blend of oversight and involvementLeona Fitzgerald and Denise Moody, PPD 06.12.18
-
Breaking News | Industry News | Promotions & Moves | QA/QC
Melissa Ertl Joins PCI as Quality Head for Philadelphia
To lead quality activities at Philadelphia commercial packaging center of excellence05.14.18
-
Analytical Services | QA/QC
-
Bio News | Breaking News | Industry News | QA/QC | Regulatory Affairs | Validation
Samsung BioLogics Achieves Regulatory Milestone
Becomes first in South Korean pharma industry to achieve ISO 22301 certificate04.27.18
-
Analytical Services | Breaking News | Industry News | QA/QC
LSNE Expands Capabilities and QC Laboratory Space
Will build new state-of-the-art laboratory to support its growing pharmaceutical and medical device client base04.10.18
-
QA/QC
Pharmacovigilance Market to Grow Significantly via Contract Outsourcing
The crucial need to monitor the efficiency and after effects of drugs will drive pharmacovigilance marketGlobal Market Insights 02.16.18
