Excellence in compliance is a critical success factor in any FDA-regulated operation, whether in R&D, manufacturing or customer-facing issues such as complaints. The ability to achieve compliance efficiencies and sustainable improvements has serious impact on company revenues/expenses. Yet this is very often seen as “that’s quality’s job”, with others handing off to QA/RA and taking an arm’s length stance. This program will clearly define a process to get out of silos, move to cross-operations ownership and build towards excellence. We also cover next step keys to tracking meaningful metrics not as punishment but as reward.
This program provides a process and tools for improving the effectiveness and efficiency of compliance activities. It is built around the critical role of diverse, cross-operational teams in building and taking ownership of improvements. The system is applicable across a range of operations in the FDA-regulated environments, and examples will be drawn from diverse areas to illustrate how this can be implemented. The program provides some diagnostics and problem identification tools to use in setting up for mapping and metrics success. Participants will leave with a well-defined map for implementation. This includes how to define priority areas, gaining management commitment, engaging appropriate teams and utilizing cross-operational expertise for maximum results.
· Compliance as an operational priority with revenue impact
· Silos and ownership — the critical cross-operational team
· Diagnosing expertise and functional areas to involve in each project
· The base process – what and why; easy fixes and longer term targets
· Team identification of new process maps with timelines and specific goals
· Management’s role at each stage— commitment, decision-making, oversight
· The challenge of change in a regulated environment — learning and unlearning
· Information flow – just enough, only when needed
· Establishing the metrics ‘dashboard’ – fewer are better
· Internalizing the team approach, metrics review, rewards, long term success
· Senior management
· Compliance directors and managers
· Regulatory affairs professionals
· Quality Assurance staff
· Manufacturing and engineering directors
· R&D directors and managers
Physical CD-USB of recorded session will be despatched after 72 hrs on completion of payment
Dorothy Erlanger is a process and metrics expert who has an established system/process for improvement leading to sustained compliance excellence. Combining her process and scientific background with facilitation expertise, Ms Erlanger leads teams to a fundamental shift in thinking and operations around FDA compliance. Her metrics work has been used by corporations for over 20 years and has included R&D, manufacturing/production and customer-facing issues such as complaints. Her Metrics for Excellence processes have been successfully implemented in Pharma and Medical Device companies.