Market Research Report - 242694
Pharmaceutical Compliance Best Practices: Ensuring Quality Through Documentation, Training, and Auditing
|Published by||Cutting Edge Information|
|Published||Content info||119 Pages|
|Pharmaceutical Compliance Best Practices: Ensuring Quality Through Documentation, Training, and Auditing|
|Published: May 25, 2012||Content info: 119 Pages||
Each year, regulatory non-compliance costs the life sciences industry billions of dollars in fines, recalls, audits and more. To avoid these missteps, companies rely heavily on experienced compliance teams, which provide oversight from the earliest R&D to the very end of the product lifecycle.
Compliance teams do critically important work across a wide range of functions, but they face a raft of challenges. Simply keeping pace with the dizzying, ever-growing array of national and international standards is difficult enough, but groups also face obstacles in securing needed resources, building internal buy-in, strengthening training programs and more.
This report provides detailed benchmark data and case studies for teams seeking to improve their organizations' approaches to compliance. With metrics on budgets, staffing and support, as well as specific challenges, the findings provide a guide for compliance teams across all company types and sizes.
Team structure is critical to success. Use the report's team profiles to build effective, empowered compliance groups. Understand internal alignment models, leadership, staffing levels and outsourcing.
Striking the balance between over- and under-compliance is an art and a science. Leverage digital training to keep employees up-to-date with the latest policies and regulations, enforce employee accountability and escalate problems via proper channels. Explore training metrics to spot recurring trouble spots, improve processes and avoid costly compliance issues.
Compliance teams juggle a staggering number of laws, regulations and guidelines in markets around the globe, which means increased - and increasingly complicated - workloads. Implement best practices and successful processes to meet the internal and external challenges of this reality head on.
Structure and Responsibilities
Staffing and Outsourcing
Challenges and Performance