Resources

As the pharmaceutical market continues to expand globally, regulatory affairs in pharma is making an effort to harmonize global standards and to protect the complex supply chain. Pharma companies and...

Products must be manufactured by following guidelines and in accordance with appropriate medicine manufacturing regulatory requirements, even during a pandemic and crisis management, says Susan J. Schniepp, Distinguished Fellow, Regulatory...

Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates®, discusses the quality metrics journey in determining the suitability of pharmaceutical products. One of the most discussed and debated topics on today’s...

The quest is on for machine learning (ML) to turn raw data into useful medical devices that improve outcomes and reduce burden on the healthcare system. Supporting, and someday emulating,...

The internal audit function of life science companies is one cornerstone of an effective and efficient quality management system. There are several types of audits that comprise a robust internal...

Quality inspection results should be included as part of the batch release documentation, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates. Q: My company is a contract manufacturer....