KENX Insights

White Paper: Evolving from ALCOA+ to DYNAMIC+: A Modern Framework for Data Integrity

With the rapid rate of digital change nowadays, ensuring data is secure and intact across complicated systems is the biggest challenge for the pharmaceutical industry.

Breaking Down Risk for Medical Device Hazard Analyses

In medical device risk management, the structure of a hazard analysis greatly impacts both product development and post-market surveillance

Stability considerations for drug-device combination products-21 CFR part 4 update

Combination products are therapeutic and diagnostic products that include two or more of the following: drug, biologic, and device.

STAGE 1: HIGH POTENT ACTIVE PHARMACEUTICAL INGREDIENT (HPAPI) CLEANING VALIDATION (CV)

This article not only applies to high potent (HP) active pharmaceutical ingredient (API) manufacturing, but it also includes pharmaceutical manufacturing products with HP APIs.

PRODUCT COMPLAINTS AND ADVERSE EVENTS

This article provides an overview of the receipt, investigation and categorization of product complaints. An example of a product complaint triggered by a serious adverse event is also described.

Paper 1: Improving Risk-Based Decision Making Effectiveness: Insights From Other Industries

The Pharmaceutical Regulatory Science Team (PRST), founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing science and risk-based decision making and manufacturing approaches… see more

Paper 2: Improving Risk Based Decision Making Effectiveness: A Case For Risk Decision Review Points (KDRPS) In The Quality Risk Management Process

The Pharmaceutical Regulatory Science Team (PRST), founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing science and risk-based decision making and manufacturing approaches.

Paper 3: Improving Risk Based Decision Making Effectiveness: Determining The Level Of Formality

The Pharmaceutical Regulatory Science Team (PRST) founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing Science and Risk based decision making and manufacturing approaches. Since its inception, the PRST has continued… see attached

Paper 4: Improving Risk Based Decision Making Effectiveness: Addressing Uncertainty

The Pharmaceutical Regulatory Science Team (PRST) founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing Science and Risk based decision making and manufacturing approaches.

Cleaning Validation Program Design: Risk-Based Lifecycle Approach

In traditional monoclonal antibody (mAb) manufacturing, the first purification process step of crude harvest (obtained from cell culture) is Protein-A Chromatography. This expensive column resin is often under-utilized for clinical or orphan drug products since the chromatography columns are dedicated per product…