Ask the Expert

Latest News

Cancer Question | Image Credit: ©freshidea - Stock.adobe.com

August 2nd 2024

The implementation of new quality control methods must be reported to regulators, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

July 1st 2024

Post-Warning Letter Interaction with FDA

By Siegfried Schmitt

June 2nd 2024

Elements for a Sustainable Environmental Monitoring Program

By Susan J. Schniepp, Zachary S. Anderson

May 2nd 2024

Good Manufacturing Practices for Emerging Therapies

By Siegfried Schmitt

April 1st 2024

Focusing on Effectiveness for CAPAs

By Kate Rice, Susan J. Schniepp

Latest Videos

Ask the Expert: Complying with 21 CFR 211.110

Ask the Expert: Product Inspection, Part One; Risk Mitigation in Secondary Packaging

Non-Animal-Derived Reagents for Endotoxin Testing

Retrofitting Facilities for Cell and Gene Therapy Production

Cell and Gene Therapy Production Facilities

Submitting Regulatory Applications Connects to Quality

Quality Considerations for Using AI in Bio/Pharma

Quality Considerations in Changing Excipient Providers

More News

Ensuring Contractors Perform Good Distribution Practices

BySiegfried Schmitt

March 1st 2024

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

Computer Validation Confirms Evidence

BySusan J. Schniepp

February 1st 2024

Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Are You Ready for Inspection?

BySiegfried Schmitt

January 1st 2024

Reviewing regulatory documents, such as 483 forms and Warning Letters, can aid in determining a facility’s inspection readiness, says Siegfried Schmitt, vice president, Technical at Parexel.