Quality Systems

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

Articles

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

Emerging Therapies and GMPs

Feliza Mirasol is the science editor for 

In the new draft guidance, FDA provides recommendations on cell safety testing of human-sourced allogeneic cells for sponsor companies.

New FDA Draft Guidance Issued for Sponsors of Allogeneic Cell-Based Medical Products.

The agreement, which will allow participants to share confidential information on medical and medicinal products, builds on the cooperation fostered between the two regulatory authorities during the COVID-19 pandemic.

Confidentially Agreement Signed Between European Union and Republic of Korea Regulatory Bodies

The majority of PMCs/PMRs are proceeding according to schedule.

FDA Reports on Status of Postmarketing Requirements and Postmarketing Commitments

Michele Duggan is senior manager, Regulatory Affairs, at Thermo Fisher Scientific.

Regulations for mRNA products are evolving as the market for mRNA expands. 

Navigating an Uncertain Regulatory Environment for mRNA-based Products

A panel of experts went over new regulatory requirements for contamination control and gave guidance on implementing a contamination control strategy in cell and gene therapy facilities at INTERPHEX 2024.

INTERPHEX 2024: Implementing Contamination Control Strategies in Cell and Gene Therapy Facilities 

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Videos

Susan Schniepp, distinguished fellow, Regulatory Compliance Associates, and co-chair of board of directors, Parenteral Drug Association, demonstrates QMS impact on quality maturity at INTERPHEX.

Susan Schniepp of Regulatory Compliance Associates Explores the Impact of QMS on Quality Maturity (INTERPHEX 2024)

Former FDA drug investigator, Daniel Roberts, discusses the importance of updating process validation and maintaining proper data integrity at a keynote session during INTERPHEX.

Keynote Session Highlights Importance of Process Validation and Data Integrity (INTERPHEX 2024)

C3TI will promote CDER’s clinical trial innovation activities both internally and externally.

FDA Establishes Center for Clinical Trial Innovation

The draft guidance provides recommendations for data integrity for clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted with drug applications.

Regulatory/GMP Compliance