Our company understands the technology and medicines in the Pharmaceuticals industry which is consistently progressing. Our team of experienced USA professionals stays current about the latest drug manufacturing trends. We bring 25 years for USA Pharma industries practical knowledge and experience to you.
Training Modules:
Module 1: 1) CGMP overview: Talk about CFR 21 Part 210 – Current Good Manufacturing Practice in Manufacturing Processing, Packing or Holding of Drugs (USFDA)2) CGMP Documentation: What needs to be followed during the manufacturing process, what are the steps for the cGMP documentation? 3) US FDA and EU prospectus on manufacturing quality medicines, and multiple case studies from the big Pharmaceutical companies.4) Exporting Medicines: What are the critical barrier in exporting drugs in various countries and how Bangladesh can overcome that barrier?5) Technology Transfer: How to smooth the process of transferring a product from R & D to production, what are the important steps to follow? Who are responsible for and what?6) What are the steps to follow exporting drugs in USA and other countries and how develop the background to move forward?Module 2: 1) Validation Overview by Categories: How to determine what kind of validation (IQ, OQ, PQ) is required and what kind of testing is required during validation of the systems.2) Strategies and techniques of validation (Equipment, systems, computer, facilities, utilities, laboratories and cleaning) 3) Providing templates for various validation documents and SOPs. 4) Facilities Auditing: How to complete internal facility auditing before open to the USFDA, EU or WHO regulatory inspection for new drugs. 5) Change Control Program: How to initiate change control program, what needs to be included, who are responsible for the approval process, why change control is important? How to manage change control program?6) Deviations: How to write deviation and what information needs to include in the deviation report. 7) Corrective and Preventive Action (CAPA): How to initiate and what procedures should be followed for CAPA and how to tract it until its completion.8) Total Quality Management (TQM) settings: How to set-up total quality management and how it will help to produce quality medicines with expedite approval process in various countries.9) Implementation of Process Analytical Technologies (PAT): How PAT helps in the industries to expedite the approval process.