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Navigating 340B Program Changes in 2025

Proxsys Rx

billion in 340B savings is at risk, due to increasing limitations imposed by pharmaceutical manufacturers which could further strain the healthcare safety net and patient care services. Engage in proactive communications with 340B program stakeholders Foster transparent relationships with drug manufacturers and wholesalers.

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How to use quality risk management in validation testing

GMPSOP

Table of Contents Quality risk management principles are already effectively utilized in many areas of pharmaceuticals manufacturing business. Risk management scope definition The purpose or objective of the application of risk management needs to be clearly understood. Subscribe Step 1. All written and updated by GMP experts.

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NHC Submits Comments on FDA Draft Guidance on AI to Support Regulatory Decision-Making for Drugs/Biologics

Putting Patients First Blog

By ensuring that any inherent limitations or biases are recognized, addressed, and clearly communicated to clinicians and patients, the FDA can help sustain public trust in AI-driven regulatory processes. These variables, tailored to the intended users, can help identify where improvements are needed to support confident decision-making.

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Corrective and Preventive Action (CAPA) Procedure for GMP

GMPSOP

Immediately communicate the incident to stakeholders and initiate an internal laboratory investigation. By definition, corrective actions are required to eliminate the causes of an existing nonconformity, defect, or other undesirable situation. No, this will be a violation of good laboratory practice.

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Ep. 002 – John Mack Podcast Transcript

Pharma Marketing Network

But also everybody reaches a worldwide audience because of that because the web is worldwide by definition. I think you did an incredibly effective job of communicating what it’s like to live a life in this industry, from both sides. If you’re a pharmaceutical company or if you’re an agency or even a consultant.