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Parexel
Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.
May 02, 2022
Process validation for a drug product must be done with commercial scale batches, says Siegfried Schmitt, vice president, Technical at Parexel.
March 15, 2022
This article discusses select industry experience with regulatory authorities utilizing alternative mechanisms for assessing compliance as part of their review and approval of existing marketing authorizations or new applications.
March 02, 2022
Auditors must have access to the batch records of the activities they are reviewing, says Siegfried Schmitt, vice president, Technical at Parexel.
January 02, 2022
Siegfried Schmitt, vice president Technical at Parexel, discusses the difficulty of operating non-GMP and GMP quality systems in the same facility.
November 02, 2021
Siegfried Schmitt, vice president, Technical at Parexel, comments on the new paradigm of remote audits.
September 02, 2021
Siegfried Schmitt, vice president, Technical at Parexel, provides best practices for switching from paper-based to automated processes.