Topic

 has more than 20 years of experience in the pharmaceutical industry. She has built her career in the areas of computer system validation, IT quality, and computer systems quality assurance. And while her current role focuses on data integrity, DI has been an important driving force throughout her entire career. She is an audit trail review subject matter expert, a leader in process improvement, and happily challenges the status quo.

Articles

Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.

A Novel, Enhanced, and Sustainable Approach to Audit Trail Review

The company is voluntarily recalling one lot of cefazolin for injection, USP, 1 gram per vial due to customer complaints of the wrong product being included in a carton.

Sandoz Recalls Cefazolin Due to Mispackaging, Opens Biosimilar Facility in Slovenia

Videos

In this episode of the Ask the Expert video series, Simona Guidi, Associate Director, Cell and Gene Therapies at ProPharma, discusses the options available for controlling adventitious contamination in cell processing and the use of closed processing systems for cell therapy production.

Ask the Expert: Adventitious Contamination Control

The 12th edition of the European Pharmacopoeia will be an all-digital, redesigned, user-friendly issue. 

European Pharmacopoeia Goes Digital

A total of 13 drugs were granted recommendation for market authorization at EMA’s CHMP June 2025 meeting.

Six Biosimilars Part of EMA’s Authorization Recommendations in June

Nishant B. Thakar, RPh, PharmD is assistant professor Clinical Sciences, Roosevelt University College of Science, Health, and Pharmacy.

 is clinical laboratory instructor, University of Illinois College of Pharmacy in Chicago, IL, USA.

Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling.

Pharmaceutical Compounding Calculations, Part Two–Bulk Drugs

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

NIBRT, Firefinch, and eg technology will join the center, adding to its collective of healthcare innovators.

EIT Health Ireland–UK Expands European Network with Three New Members

The new facility offers cleanroom packaging and high-sensitivity analytical testing.

BASF Opens GMP Manufacturing Facility in Michigan

The Commissioner’s National Priority Voucher can be used by drug developers to participate in a novel priority program for shortened drug approval review time.

FDA Voucher Program Provides Shorter Drug Application Review Time

The warning letters deal with a range of violations involving items from personal hygienic products to mismarketed analgesics.

Quality Systems