Abstract: The concept of regulatory document quality in the pharmaceutical industry derives, in part, from the idea of “scientific data integrity” set out in good clinical practice (GCP) guidance. In practice, the concept of document quality in this regulatory context is structured around key elements that include writing that is clear, precise, concise, consistent, and sound scientifically.
Achieving these key elements requires the development and adherence to strict working practices by individuals with the highest levels of expertise. In this Expert Insights webinar, MMS will explore the challenges and pitfalls of ensuring documents for regulatory audiences are high quality, without error and fit for purpose.
Attendees will learn:
- The parameters that define document quality
- How to create processes that foster an environment of “first-time quality”
- Who should be the gatekeepers of quality?
- Balancing idealism and pragmatism in quality control
- Changes to the way QC teams are working including emerging QC innovations
- Methods in use to measure document quality
Jim Newman, Senior Manager, Regulatory & Medical Writing (UK)
Ravi Kishore Kandula, Team Lead – Quality Control (Bangalore, India)