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Compliance Management

For pharma manufacturers, regulatory compliance is a focal point of company strategy. Pharma manufacturers need to comply with an array of regulations, so enabling a proper compliance management strategy will help build quality and security into the product lifecycle from the start. Here you will find broad coverage related to the tools and strategies needed to maintain compliance.

Articles

Getting drug quality right the first time

CAPA remains an integral element of cost-effective quality management in pharma

Juggling the regulatory complexities of global clinical trials

Deploying an automated process can help simplify safety and compliance information

Glass pieces trigger Merck recall

Merck has voluntarily yanked 22,000 vials of Cubicin after a piece of glass was found in a vial.

Maintaining compliance beyond the pandemic

Investing in employee readiness will be crucial to present and future success

The time for quality content standards is now

Adopting a standardized approach to content management can transform quality operations

News

Wintac slapped with FDA warning letter

GSK Gains First FDA Approval for Autoimmune Disease Drug

Sanofi-Aventis Wins FDA Approval for Follow-On Diabetes Drug

FDA OKs First Biosimilar for Breast, Stomach Cancers

Compliance Director Pleads Guilty to Conspiracy

Indivior's Opioid-Use Drug Earns FDA Approval

Is it time to call the dogs off drug testing?

One group is putting pressure on the FDA and Congress to move pharma away from animal modeling in drug development

A better pH measurement approach

How purpose-built sensors can help overcome biopharma single-use challenges

E-learning: Shifting pharma’s training strategy amid COVID-19

With the advancement in learning technologies, training departments should be poised to continue to support compliance and competency needs in the pharma manufacturing

The higher they fly: Managing pharma’s COVID-19 reputation risk

The response to the COVID-19 crisis is casting a bright reputational halo over the entire industry. But if you’re going to fly close to the sun, you’d better be sure your wings...