When contracting with external experts, you may be uncertain about whether to select a consulting fi...
When it comes to ensuring compliance and avoiding FDA warning letters, regulatory affairs consultant...
Creating an effective quality system (QS) requires a significant investment of time and resources. T...
Medical device labeling changes are made for a wide array of reasons. When a manufacturer makes chan...
In 2020, the most common reason for FDA's 483 observation letters was "procedures for corrective and...
The key to a successful quality audit is selecting a highly qualified auditor. Since the quality of ...
For FDA (U.S. Food and Drug Administration)-regulated industries, organizations, and projects, the i...
Developing an effective regulatory strategy is more than following the step-by-step requirements out...
Quality managers everywhere will attest to the fact that effective document control is critical to t...
Regular internal audits are a vital part of QMS maintenance and are in many cases a regulatory requi...