Pharmaceutical Compliance Best Practices

Ensuring Quality through Documentation, Training and Auditing

Pharmaceutical Compliance Best Practices

$995.00

An effective, empowered pharmaceutical compliance function ensures that companies avoid the cost and trouble associated with fines, recalls, audits and more. This report’s benchmark data and in-depth team profiles detail compliance structures, staffing, resources and best practices across different company types and industry sectors. Build an organization that features both strong central oversight and specialized on-the-ground expertise. See how other organizations face key challenges, such as keeping pace with the everchanging array of national and international standards — and how they leverage digital training tools to maximize employee understanding, track training, and identify and eliminate trouble areas.

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REPORT HIGHLIGHTS

Pharmaceutical Compliance Best Practices: Ensuring Quality through Documentation, Training and Auditing

  • Publication Date: May 2012
  • Pages: 119
  • Chapters: 2
  • Metrics: 500+
  • Charts/Graphics: 73

Data split by company type:

  • Top 20 pharma
  • Top 50 pharma
  • Biotech
  • Medical devices
Report Features

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.

Reason to Buy

Team structure is critical to success. Use the report’s team profiles to build effective, empowered pharmaceutical compliance groups. Understand internal alignment models, leadership, staffing levels and outsourcing. Explore training metrics to spot recurring trouble spots, improve processes and avoid costly compliance issues. 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.

Target Audience

Executives, directors, and managers involved in the following areas should consider purchasing this report:

– Pharmaceutical compliance
– Product commercilization
– Product marketing
– Market research
– Regulatory Affairs
– Clinical Development
– Medical Affairs

Chapter Example

The pharmaceutical industry relies heavily on compliance teams to ensure that business operations do not run afoul of regulatory bodies. In addition to several other tasks, these teams have the critical triple mandate of developing standards, training staff on those standards and monitoring employees to gauge adherence to those standards. They operate across a range of functions within companies to ensure compliance is enforced from product development to commercialization.

Nonadherence costs the industry billions of dollars annually in fines, recalls, audits and other punitive noncompliance actions by governmental agencies. Systemic noncompliance can spell the demise of whole companies. Strict adherence to the business rules, on the other hand, is the competitive advantage companies are looking for: the first to stumble on regulations could quickly find itself struggling to catch up with companies that avoided such trouble. To complicate matters, compliance teams juggle an increasingly dizzying array of international standards and regulations.