Amreteck Pharma, USA plans to develop Pharmaceutical professionals in Bangladesh, India & China using the strategies & techniques that are being used in the USA Pharmaceutical Industries. Quality Assurance Personnel Training Program: 1. Technique of Reviwing Batch Records, SOPs, GMP documents 2. Determine the sampling size and number for the in-process and final step of the manufacturing process 3. Technique of conducting products failure 4. Technique of Conducting Batch Failure Investigation 5. Planned & unplanned Deviations 6. Develop and Management of CAPA system 7. Products Disposition Plan 8. Prepare for USFDA, MHRA, ANVISA (Brazil), WHO and other regulatory inspections 9. Develop & Management of Equipment & Process Change Control System 10. Develop & Management of Document Change Control System 11. Technique of Developing Anual Product Review (APR) Documents 12. Annual GMP Training Program 13. SOPs Training and Implementation Procedure 14. Management of QA personnel 15. How to conduct internal and external GMP Aduits Quality Control (QC) Lab Personnel Training Program: 1. Technique of Understanding and Operation of the Lab Equipment 2. Lab Equipment Calibration and Verification 3. Technique of Recording QC Lab Testing Data 4. OOS Investogations and Reporting 5. Raw Materials Testing requirements and reporting 6. Method Validation 7. GC Method & HPLC Methods 8. Qualification of Lab Equipments 9. QC Sampling Techniques Validation Personnel Training Program: 1. Technique of Writing & Executing IQ, OQ, PQ, PV, CLN Validation Documents 2. Technique of Developing Manter Validation Plan & Project Validation Plan 3. Technique of Writing SOPs 4. Products Scale-up Technique and Documents requirements Engineering Personnel Training Program: 1. Develop and management of CAD Drawings 2. Technique of understanding the requirements of the process equipments, systems, facilitites, utilitites 3. Technique of Dry Run/Engineering Run 4. Development of Engineering TOP (Turn Over Package) 5. Development and Management of Maintenance Program 6. Development and Management of Calibration Program Regulatory Personnel Training Program: 1. Technique of Development and Submisssion of Products DMF Files 2. Understanding of US FDA NDA, ANDA fillings requirements 3. Understanding of reporting of process changes to US FDA 4. Understanding the USFDA, MHRA, ANVISA (Brazil), WHO and other regulatories agencey DFM files review process and communication Contact us at info@amreteckpharma.com for more topics that are being provided by Amreteck Pharma, USA!!! Regards,
Bangladesh is far behind as far as quality pharmaceuticals skill workers are concern. Amreteck Pharma, USA believes that Bangladesh would need to develop minimum 10,000 quality pharmaceutical professionals (QA, QC, Engineering, Validation, Operators, EHS, Inspection, Audits, R & D) every year to meet its growth projection in the Pharmaceutical sector.
Amreteck Pharma, USA would start working on these programs in 2Q, 2011. Please see the snapshot of the program to develop Quality Pharmaceutical skill workers. Actual USFDA and US Pharmaceuticals working experiences will be used during the following training programs:
Mr. M. M. Chowdhury, ChE, Engineering, Validation, Quality & GMP Expert
Founder/CEO/Pharmaceuticals Consultant,
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