Quality Systems

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Articles

Siegfried Schmitt, principal consultant, PAREXEL International, discusses how to find the root cause of the problem.

Root Cause Analysis–Finding the Root of the Problem

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses standard operating procedures for the regulatory affairs department.

Quality System for a Regulatory Affairs Department

The agency cited Apotheca Supply, a repackager and relabeler of pharmaceuticals for CGMP violations.

FDA Issues Warning Letter to Repackaging Facility

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.

Reporting Quality Metrics to FDA

Andrew Harrison is chief regulatory affairs officer and general counsel with Regulatory Compliance Associates.

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

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to create a robust CAPA system and how to identify root cause.

Creating Robust CAPA Systems

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to streamline the document management process during market expansion.

Managing Market Expansion’s Effect on Procedures

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to write standard operating procedures that hold up to audits.

Crafting Standard Operating Procedures

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to ensure archive records can be retrieved.

Good Documentation Practice: Saving Data for the Long Term

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for automated systems.

Computerized Systems Validation

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general council, both of Regulatory Compliance Associates, discuss the requirements for a successful corrective action and preventive action (CAPA) system.