Mariann Neverovitch
Sr. Manager Logistics Operations | Cleaning Validation SME
Mariann Neverovitch, MS Pharmacy
Research Scientist at Bristol-Myers Squibb with over 20 years of experience in HPLC method development and validation for drug product, API and intermediates.
Cleaning Validation Subject Matter Expert with 15+ years of experience in cleaning verification method development and support. Since 2010 leading cleaning verification program in Support of Clinical Supply Operations
Presented a number of papers on integrated approach in method development, analytical support, and challenges in life cycle management of analytical methods for determination of residual product on the equipment, and development and implementation of visual inspection program.
Co-Author of ASTM WK15778 “Standard Guide For Science-based and Risk-based Cleaning Process Development and Validation” and number of articles for Cleaning Validation For the 21 Century series.
Member of Eastern Analytical Symposium (EAS) Governing Board
Member of United States Pharmacopoeia (USP) Expert Committee
DAY 1: May 28th, 2026
SESSION: Analytical Approach for Implementation of Visual Inspection
◆ Visual inspection following equipment cleaning is a mandatory step in the cleaning verification workflow for pharmaceutical equipment. Equipment must pass visual inspection before swab sampling for analysis can be performed.
◆ Since a significant number of low-risk compounds are visible well below established safety levels, it is possible to justify equipment as “visually clean” without performing swabbing analysis. Internal studies performed at BMS showed that over 90% of participants could identify residual product at a level of ~2 ppm without preliminary training.
◆ The implementation of a robust visual inspection qualification program and clear “Visually Clean” inspection parameters can enable visual inspection to be used to qualify equipment in lieu of swab analysis for low-risk products.
DAY 1: October 1st, 2025
SESSION: Lifecycle Management of Analytical Methods for Cleaning Verification Support
◆ Common analytical techniques (HPLC, TOC).
◆ Sensitivity, specificity and validation of analytical methods.
◆ Recovery studies and swab sampling considerations.
DAY 2: October 2nd, 2024
SESSION: Lifecycle Management of Analytical Methods for Cleaning Verification Support
◆ Equipment Cleaning is a critical GMP element of the Manufacturing Process. It ensures quality and safety of future batch. Cleaning Validation/verification is a measurement of the effectiveness of the cleaning process.
◆ In this presentation we will go over advantages and challenges of specific and nonspecific analytical methods based on risk assessment of the residual product.
◆ Case studies, training and qualification programs will also be discussed.
DAY 1: September 29th, 2021
SESSION: Lifecycle Management of Analytical Methods for Cleaning Verification Support
◆ Equipment Cleaning is a critical GMP element of the Manufacturing Process. It ensures quality and safety of future batch. Cleaning Validation/verification is a measurement of the effectiveness of the cleaning process.
◆ In this presentation we will go over advantages and challenges of specific and nonspecific analytical methods based on risk assessment of the residual product.
◆ Case studies, training and qualification programs will also be discussed.
