Robert Michalik

Robert Michalik is advisor (Quality and Corporate Compliance) at Shabas Solutions LLC.

Articles

Businessman pressing quality management button on virtual screens. Business, Technology, Internet and network concept.Image Credit: ©putilov_denis - stock.adobe.com

QMM for Pharmaceutical Manufacturers– Implications for Drug Manufacturers, API Suppliers and Contract Manufacturers

Somnath Mishra;William Hauck ;Clyde Schultz;Zachary Royal;Robert Michalik

May 2nd 2023

QMM principles and practices can positively influence a sustainable drug supply and bolster the bottom-line of drug manufacturers, API suppliers, and CMO/CDMOs.

Introduction to Pharmaceutical QMM Model: QMM Assessment to Promote Pharmaceutical Operational Excellence

Somnath Mishra;William Hauck ;Zachary Royal;Robert Michalik

December 3rd 2022

QMM is an evolutionary advancement in FDA’s quality management maturity initiative that provides industry with a viable methodology to assess and improve manufacturing quality and supply chain reliability.