Siegfried Schmitt

Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, at Parexel, explain a company’s regulatory affairs department is subject to inspections by regulators and should, therefore, be prepared.

Three regulatory actions are converging to move biologics, gene therapy, and the ATMP platform forward quickly, say Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, technical, Parexel.

Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how companies can investigate patient complaints involving prefilled syringes and combination products.

Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, provide advice on creating a robust out-of-specification procedure.

Alternative methods to the use of animals in pharmaceutical testing are becoming more used and accepted. Laura Lotfi of Charles River breaks down the basics of virtual control groups in drug development.

Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how companies can investigate patient complaints involving prefilled syringes and combination products.

In this episode of Ask the Expert, Susan J. Schniepp and Siegfried Schmitt discuss how companies should approach preventing product recalls.

It is necessary to search beyond the term “data integrity” to stay abreast of developments in this field, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

In this episode of Ask the Expert, Susan J. Schniepp, Nelson Labs, and Siegfried Schmitt, Parexel, discuss the benefits of orphan drug development and how a mid-sized company can work with regulators through the pathway to approval.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs company, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how involving procurement early on in drug development can ensure a quality product.

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates (RCA), and Siegfried Schmitt, Parexel, tackle the ever-growing problem of having a properly trained workforce with a variety of needed skill sets.

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates (RCA), Siegfried Schmitt, Parexel, and Anita Michaels, RCA, explain how CDMOs can best handle regulatory inspections and client expectations.

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates, and Siegfried Schmitt, Parexel, give their opinions on why those working in the pharmaceutical industry should lend their voices to draft regulations.

Siegfried Schmitt, PhD, vice-president, Technical at Parexel, answers questions on the use and benefits of real-world evidence for small-molecule and large-molecule drug development.

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates, and Siegfried Schmitt, PhD, Parexel, answer questions on the use of real-world evidence for both small-molecule and large-molecule drug development. In addition, they tackle a question on supply chain security problems that arise during transportation of pharmaceutical goods.

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss if and when identity testing is necessary to be performed on a final product when the API is sourced from a third party.

Speedier implementation of the Post-Approval Change Management Protocol is essential for it to have a positive effect on supply security, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how to address an FDA warning letter citation for a failure to establish a quality control unit.

While global harmonization exists, there are still differences between the US and European GMP requirements that manufacturers should know, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

Compliance and competitiveness are key factors in aseptic processing, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

AI regulations in healthcare are rapidly evolving, and one should consult with regulatory subject matter experts, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

The product license holder must have a supplier oversight system in place, says Siegfried Schmitt, PhD, vice president, Technical, Parexel.

Updating your audits and inspections program ensures inspection preparedness, says Siegfried Schmitt, vice president, Technical at Parexel.

Communication and meetings with FDA after receiving a warning letter demonstrates a serious response, says Siegfried Schmitt, vice president, Technical at Parexel.

Guidance documents and interaction with FDA can help manufacturers stay in GMP compliance, says Siegfried Schmitt, VP Technical, at Parexel.

The license holder should negotiate, educate, contract, and then oversee the transportation contractor, says Siegfried Schmitt, vice president, Technical at Parexel.

Process validation for a drug product must be done with commercial scale batches, says Siegfried Schmitt, vice president, Technical at Parexel.

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.

Auditors must have access to the batch records of the activities they are reviewing, says Siegfried Schmitt, vice president, Technical at Parexel.

Siegfried Schmitt, vice president Technical at Parexel, discusses the difficulty of operating non-GMP and GMP quality systems in the same facility.