PDA/FDA ICHQ10

Has your company faced stock outs due to quality problems in the past couple of years? Have you experienced different and stricter regulatory Health Authority dialog recently? Are you considering how deviations and failures in your operations can be reduced and how the product supply can become more reliable and predictable? This ICH Q10 workshop will cover each of these questions and be directly targeted to executive and senior operations management.

The ICH Q10 Document is the first time a regulatory guidance has significantly ventured into the area of expectations to senior management outside those of strictly meeting the GMPs. There are now clear expectations to management in terms of sponsorship & support, allocating adequate resources, setting clear roles and responsibilities, and sponsoring continual improvements of the Pharmaceutical Quality System. Quality is no longer just for the Quality Professionals. Quality must be owned by all across the technical disciplines in the company and from the shop floor to the most senior executive.

During this workshop, participants will meet and learn from other industry leaders on how ICH Q10 can be used as an incredibly efficient and powerful way to drive improvements within your company, including improving the predictability of your product supply, proactive identification of quality issues, selecting the right KPIs to drive the right behaviors, and delivering a culture of accountable leaders across the organization.

This is the workshop to attend if you want ‘everything quality in one package' as it relates to expectations of Operations and Executive Leaders in our pharmaceutical and biopharmaceutical industry.