Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of BioPharm International's Editorial Advisory Board.

Susan J. Schniepp

Articles

When in-person training may not be feasible, there are still opportunities to ensure employees receive the required training, says Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates.


Training During a Pandemic

ICH will be taking industry comments under consideration when it revises its Q9 guideline in order to clarify QRM requirements, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

ICH to Revise Quality Risk Management Guideline

Quality risk management plans provide identified actions to ensure a continuous supply of safe
and effective drug products


Quality Risk Management Plans Create Effective Quality Systems

Investigating deviations or failures of combination products needs to accommodate both the drug and device components, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished 

Author | Susan J. Schniepp