Risk Management

Quality risk management solutions begin and endure as risk-based thinking. As a pharmaceutical, biotechnology or medical device company, you benefit from a logically efficient, forward-looking process development and product manufacturing function.

Emphasize an integrated quality risk management effort. Drive successful outcomes on knowledge, skill, experience, and curiosity. Yes, curiosity. Just how much will risk-based thinking impact your efficiency and outcomes? Let’s find out.

The Approach.

Dispel the myth. Addressing risk and protecting patents requires a formal approach. Regulators are demanding a discernably structured, consistent approach to risk-based thinking. ValSource equips you to meet these fast growing expectations.

The ICH Q9 Quality Risk Management guidance is just a starting point. What next? Practical, unexciting issues persist. Where to start? What scales to use? What tools exist beyond FMEA? Answers await.

The Pains.

Uninformed and poor decision-making.

Provisional and sporadic QRM competencies.

Few or no ongoing QRM learning events.

An organizational culture that does not motivate or support risk-based thinking.

The Relief.

Pragmatic, tactical decision-making.

Predictable, current and evolving QRM competencies.

Continuing QRM learning events at team, facilitator and leadership levels.

An organizational culture that motivates and supports risk-based thinking.