Professional Development Opportunities
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Professional Development Opportunities

When considering paying for personnel to attend industry conferences & networking events, decision-makers often focus on attendance costs and ‘downtime’. They forget to consider the productivity increases and financial benefits of investing in professional development opportunities (PD events) for their employees. PD events are best viewed as an ‘uptime’ opportunity because time spent with industry…

Implementing a new Quality Management System (QMS): What comes first? The chicken or the egg?

Implementing a new Quality Management System (QMS): What comes first? The chicken or the egg?

So, you’re working for an exciting brand-new start-up. It’s getting to the pointy end – you understand all your processes, but you need to have these documented and in place to control and direct your regulated activities, ready for your initial regulatory inspection. Or perhaps your business is evolving – you need to incorporate regulation-driven…

Corrective and Preventive Action – is the CAPA closed?
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Corrective and Preventive Action – is the CAPA closed?

Corrective and Preventive Action (CAPA) is a key process within a pharmaceutical quality management system. It is the process of identifying and documenting corrections and improvements to systems and processes to reduce the risk of a deviation, non-conformance or quality issue occurring or recurring (hereafter referred to as an ‘issue’). A CAPA record must include…

We have a Pharmaceutical Quality System, why do we then need a Quality Culture?
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We have a Pharmaceutical Quality System, why do we then need a Quality Culture?

Once the Pharmaceutical Quality System (PQS) (as per ICHQ10: Pharmaceutical Quality System) is implemented, it must be ensured that it continues to be effective, and for this to happen there has to be a clear commitment from senior management to a Quality Culture. There are several ways senior management can demonstrate their commitment to the…