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Technical Aspects of the Pharmaceutical Industry

Technical Aspects of the Pharmaceutical Industry and Regulatory Affairs Workshop

Training Overview

This training will help new and recent Pharmacy / Biology / Chemistry graduates, QA/QC officers, regulatory affairs employees, chemists, biologists,  and other stakeholders at pharmaceutical companies and drugstores, to get oriented on all the technical aspects relevant within the pharmaceutical industry and regulatory affairs. It usually takes a long time and effort for employees within a pharmaceutical company or regulatory affairs to understand the many aspects, documentation, regulations, roles, responsibilities, of the pharmaceutical industry. This intensive training will act as an orientation for the different stakeholders that will help them hit the ground running from day one, with little ambiguities regarding what goes on in other technical departments. It also helps those that have been in the industry for a while but lacks the technical understanding and vocabulary required to cooperate with other departments. Last, it will help new graduates understand the technical career track within the pharmaceutical industry and regulatory affairs so they can choose the right career path.

Program Outline

Day 1

  • An overview of the pharmaceutical industry in Jordan and the Middle East.
  • National and international regulations and requirements for the pharmaceutical industry.
  • An in-depth look at all the technical departments within a pharmaceutical company: R&D, QA, QC, Production, Engineering, Materials & Planning, Scientific Support, Regulatory, and Registration.
  • A general overview of important topics related to the technical field within the pharmaceutical industry
  • Site Master File (SMF)
  • Sites Inspection & Auditing.
  • Good Manufacturing Practices (GMP)
  • Pharmaceutical Engineering (Layouts, Flow, HVAC, Water, Air, Facilities)
  • International Council of Harmonization (ICH) Guidelines.
  • Quality systems (Documentation system, Protocols, Standard Operating Procedures, Standard Testing Procedures, Forms, Records)
  • Master Formula, Batch records & Batch Release
  • Product Classification
  • Product registration

Day 2

  • Technical files (CTD and eCTD)
  • Drug Master File (DMF)
  • Product Development (Preformulation Studies, Formulation, Scaling up)
  • Analytical Methods Development and Validation
  • Related Substances (known impurities, unknown impurities, inorganic impurities)
  • Herbal Products (Standardization, Method of Analysis, Markers)
  • Pharmaceutical Microbiology (Products Preservation, Microbiological Quality, Air Quality)
  • Stability Testing (Accelerated, Long Term, Intermediate, Force degradation)
  • Bioequivalence / Bioavailability (Reference Products, Generic)
  • Validation (Process, Cleaning)

Who should attend

This workshop will particularly interest all those who need to learn about all the technical aspects of the pharmaceutical industry, including:

  • Fresh-graduate Pharmacy majors, who want to explore career options in the technical field of the pharmaceutical industry or regulatory affairs.
  • Chemists, Biologists, Microbiologists, or engineers who want to work in the pharmaceutical industry jobs and lack the needed pharmaceutical background.
  • New Regulatory Affairs Employees in pharmaceutical manufacturing companies or drugstores, who need to understand the complete life cycle of pharmaceuticals starting from R&D to product launch.
  • Human Resources and Training Department personnel within a pharmaceutical company, who want to understand the needed technical competencies for technicians in various technical departments in the pharmaceutical industry.
  • Regulatory and Inspection Staff of Regulatory Authorities, who want to have the required general knowledge of the pharmaceuticals life-cycle in the pharmaceutical industry.

Certificate

We will provide a certificate of attendance for professional development to each participant who completes this workshop.