Mariann Neverovitch
Sr. Manager Logistics Operations
Mariann Neverovitch
MS Pharmacy; Research Scientist at Bristol-Myers Squibb.
Cleaning Validation Subject Matter Expert with 15+ years of experience in cleaning verification method development and support. Leading cleaning verification program in Support of Clinical Supply Operations for the ten years. Presented a number of papers on Cleaning Validation Lifecycle management and co-authored number of papers along with the international team of industry experts on Cleaning Validation in the 21st Century.
Co-Author of ASTM Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation (E3106-17), Standard Guide for Derivation of Health-Based Exposure Limits (HBELs) (E3219-20),and Standard Practice of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for residues (E3263-20).
Member of the task force team for PDA TR 29.
Member of Eastern Analytical Symposium Governing Board
Member of USP Expert Committee
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.
