Susan J. Schniepp

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

Articles

Frequently Asked Questions About Quality Control vs. Quality Assurance

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about the difference between the roles of quality assurance and quality control.

The Basics of Aseptic Processing

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about aseptic processing.

GMPs for Emerging Therapies

Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, provide answers to frequently asked regulatory questions about advanced therapy medicinal products.

The Facts About Filing Drug Applications

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about regulatory filings.

Impact of Pandemic on Permanent Procedures

Virtual audits, virtual training, and more robust quality agreements may become positive impacts on the industry, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

Training During a Pandemic

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.

ICH to Revise Quality Risk Management Guideline

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.

Investigating Combination Product Failures

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