Founder and CEO PDF Print E-mail

Mr. M. M. Chowdhury is the Founder & CEO of Amreteck LLC, a western educated and has worked in the world class pharmaceutical companies in USA and helped companies during USFDA inspections. He has been a member of ISPE since 2004. He has a Bachelor degree in chemical engineering and is in the process of getting MBA on Global Management.  

He has worked on Rx, Generic, OTC drugs, and cosmetics products and has experiences in equipment, cleaning, process, computer, utilities, facilities, and laboratories validation. He has multiple trainings in cGMP, Audits, Validation, Quality Control and Quality Assurance.Mr. Chowdhury has more than 14 years of pharmaceuticals, biotech & medical devices, biotech manufacturing experience including areas of engineering, commissioning, qualification & validation, technical support, audits, compliance, production, technology transfer, supplier/vendors audits, quality control, quality assurance and preparing for USFDA inspections and defending companies during the inspections .  He began his career as a validation engineer with Progenics Pharmaceuticals Inc, USA. In addition, he has held various management positions in Pfizer Inc, Johnson & Johnson, Schering-Plough, Sanofi, Dow Biopharmaceuticals, Élan Pharmaceuticals Inc, AVI BioPharma, CMIC-VPS Corporation, CB Fleet Laboratories and Cody Laboratories in USA.  

His professional achievements include: 

  • Developed Plant Master Validation Plans for multiple pharmaceutical companies.
  • Updated and developed comprehensive Change Control programs at multiple pharmaceutical companies.
  • Performed Gap Analysis on the existing validation documents, testing, and provide corrective actions.
  • Implemented new protocol format at multiple plants with adding more validation testing.
  • Trained multiple groups about documentation and error correction procedures at multiple pharmaceutical companies.
  • Advised and made ready multiple pharmaceutical plants for upcoming FDA Pre-Approval Inspection (PAI) from USFDA, MHRA, ANVISA (Brazil) and Health Canada.
  • Developed multiple SOPs and implemented across the plant.
  • Provided cGMP Training to multiple pharmaceutical companies.
  • Satisfactorily coordinated multiple US FDA and vendor inspections/Audits at multiple pharmaceutical companies in USA.
  • Developed CAPA and Deviation programs at multiple pharmaceutical plants.
  • Completed multiple process and technology transfer projects.
  • Helped developing and updating validation department at Pfizer Inc, Élan, AVI BioPharma, and CB Fleet Laboratories.
  • Completed re-validation and 21 CFR Part 11 compliance projects at multiple pharmaceutical plants.
  • Completed US$11 Million Aseptic filling lines project with HVAC monitoring system at Pfizer Inc.
  • Provided greater understanding and completed multiple drugs technology transfer projects from R & D to commercialization.
  • Worked in various clinical trials projects for the phases I –III products.

Affiliations:

  1. Ex-member, Public Relationship Officer for American Institute of Chemical Engineering (AIChE) (1996-1999), USA
  2. Ex-member American Management Association (AMA), USA
  3. Current Member, International Society of Pharmaceuticals Engineers (ISPE), USA