Mr. M. M. Chowdhury

is the Founder & CEO of Amreteck LLC , USA ( www.amreteckpharma.com ).  He is a Chemical & Validation Engineer and an expert of GMP compliance in the Pharmaceutical Industries.  He lives at Lynchburg , Virginia , USA  with his wife and daughter. He is currently working to expand Bangladesh Pharmaceuticals sector in Bangladesh . He has served in important positions at the following companies in USA :

1) Pfizer Inc.

2) Schering Plough

3) Aventis-Sanofi

4) Dow Chemical

5) Elan Pharmaceuticals Inc.

6) Progenics Pharmaceuticals Inc.

7) AVI BioPharma

8) CMIC-VPS Corporation

9) CB Fleet Laboratories

He has experiences in validation to all types of Solid Dosage & aseptic equipments, facilities, utilities, laboratory systems, computer and control systems, cleaning validation, process validation, and technology transfers.  He has defended multiple pharmaceutical companies during US FDA facilities inspections and Pre-Approval Inspections (PAI) for new products. 

He helped various pharmaceutical companies to building Quality Management System to manufacture quality medicines in USA. 

Prior experiences include equipment, cleaning, process, facilities, utilities, laboratory, computer validation, aseptic filling line validation, automated lyphilization and loading equipment validation, and electronic change control system supervision.  He has completed multiple projects including facility expansion projects in USA.

He believes that pharmaceuticals Industries in Bangladesh can benefit from his expertise and experiences in commissioning, validation, quality assurance, regulatory compliance, moderator for US FDA plant inspections, supervision, project management, internal aurdits, retrospective/legacy systems validation, Gap analysis, technology transfers, CAPA, change controls, and engineering. 

A few of his accomplishments are listed below:

1. Developed Plant   Master Validation Plans   for multiple pharmaceutical companies.

2. Updated and developed comprehensive   Change Control   programs at multiple pharmaceutical companies.

3. Performed   Gap Analysis   on the existing validation documents, testing, and provide corrective actions.

4. Implemented new protocol format at multiple plants with adding more validation testing.

5. Trained multiple groups about documentation and error correction procedures at multiple pharmaceutical companies.

6. Advised and making ready multiple pharmaceutical plants for the upcoming   Pre-Approval Inspection (PAI)   from   US FDA and EU .

7. Developed multiple SOPs and verified that SOPs are followed across the plant following cGMP.

8. Provided   cGMP Training   to multiple pharmaceutical companies.

9. Satisfactorily completed multiple   US FDA   inspections at multiple pharmaceutical plants.

10. Developed   CAPA   and   Deviation   programs at multiple pharmaceutical plants.

11. Completed multiple   process   and   technology transfer   projects.

12. Helped Elan Pharmaceuticals to get out from   US FDA Consent degree .

13. Helped developing and updating  validation department   at Pfizer Inc, Elan and AVI BioPharma.

14. Completed   re-validation and 21 CFR Part 11   compliance projects at multiple pharmaceutical plants.

15. Completed   US$11 Million   Aseptic filling lines project with HVAC monitoring system at Pfizer Inc.

16. Greater understanding and completed multiple drugs   technology transfer   projects from R & D to commercialization.

17. Worked in various projects in   clinical trials   of phases I to IV products.

Affiliations:

1. Current Director of Social, Political and Economical Development in Bangladesh ,   Change Bangladesh Organization, USA ( www.changebangladesh.org )

2. Ex-Member, Public Relation Officer for American Institue of Chemcial Engineering (AIChE) (1996-1999).

2. Current Member, International Society of Pharmaceuticals Engineers (ISPE) in USA , member since 2001.

3. Current Member, American Management Association (AMA) in USA

 

Thanks,

M. M. Chowdhury (Mithu), USA

Village: Kalma, Munshigonj

PH: (678) 858-5952