Quality Considerations for a Robust Data Integrity Program

Quality, with its checks and balances, is the foundation and a key to success for your pharma startup. A proactive, vigilant culture of quality is patient-focused and science-based, allowing you to identify and respond to issues while they are still small. It affects access and availability of medicines to support the commercialization of your product pipeline. Assuring quality becomes a competitive advantage as it creates higher yield, dependability, and sustainability to support your business needs.

A startup must build a culture of quality and set up consistent, reliable processes that deliver on objectives and promote continual improvement. This webinar outlines the most important aspects of quality management for a pharma startup, and how to set a foundation that builds toward a modern quality maturity model (QMM).

Discuss areas of responsibility and accountability to prioritize patient-centricity and data accuracy and how to meet current and future regulatory requirements—right from the start.

– When to start building a quality unit
– Senior Management responsibilities
– Considerations for selecting quality employees
– Centralize vs. decentralize approaches to quality units
– Governance and oversight
– QMS approaches (paper vs. electronic)

Subject area:
cGMP

Objectives (If applicable):
N/A

Target Audience (If applicable):
Drug manufacturing, pharmaceutical manufacturing, biologics organizations; Job function: quality assurance (QA), quality control (QC), operations managers, quality management, pharmaceutical quality directors, MHA, MPH.

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Global Benchmarking Tools (GBT) Category

01 National Regulatory System (RS)

Region / Country

Global

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Live Webcast
On-Demand
Registration Required

Cost

Varies

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