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Siegfried Schmitt
Siegfried Schmitt, PhD, principal consultant at PAREXEL.
Staffing and Preparation for Audits
Pharmaceutical Technology - Jan 02, 2017
Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to handle audits and inspections during business expansion.
Staffing and Preparation for Audits
BioPharm International - Jan 01, 2017
Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to handle audits and inspections during business expansion.
The Human Factor in Inspections
BioPharm International - Nov 02, 2016
Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to prepare for an inspection by a foreign regulatory agency.
The Human Factor in Inspections
Pharmaceutical Technology - Nov 02, 2016
Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to prepare for an inspection by a foreign regulatory agency.
Root Cause Analysis–Finding the Root of the Problem
Pharmaceutical Technology - Sep 02, 2016
Siegfried Schmitt, principal consultant, PAREXEL International, discusses how to find the root cause of the problem.
Quality System for a Regulatory Affairs Department
Pharmaceutical Technology - Jul 02, 2016
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses standard operating procedures for the regulatory affairs department.
Reporting Quality Metrics to FDA
Pharmaceutical Technology - May 02, 2016
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.
Reporting Quality Metrics to FDA
BioPharm International - May 01, 2016
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.
Phase-Appropriate GMP
Pharmaceutical Technology - Mar 02, 2016
Siegfried Schmitt, principal consultant, PAREXEL, discusses the regulatory requirements for CGMPs in the different phases of drug development and manufacture.
Managing Market Expansion’s Effect on Procedures
Pharmaceutical Technology - Jan 02, 2016
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to streamline the document management process during market expansion.
Managing Market Expansion’s Effect on Procedures
BioPharm International - Jan 01, 2016
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to streamline the document management process during market expansion.
Good Documentation Practice: Saving Data for the Long Term
Pharmaceutical Technology - Nov 02, 2015
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to ensure archive records can be retrieved.
Good Documentation Practice: Saving Data for the Long Term
BioPharm International - Nov 01, 2015
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to ensure archive records can be retrieved.
Computerized Systems Validation
Pharmaceutical Technology - Sep 02, 2015
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for automated systems.
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Outsourcing

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