Brochure

Training Programme

Key Features

  • Class room sessions by experts
  • Research & Development
  • Warehouse management
  • Practical Demonstration
  • Manufacturing
  • Customer Management
  • Hands on exposure in Industrial Set-up
  • Quality Management
  • Interactive Workshop
  • Quality Control

Objectives of Programme

Overview of Pharmaceutical Industry

  • Overview of pharmaceutical industry and its role in health care system
  • Career options in pharmaceutical industry
  • Different functional departments and their role in pharmaceutical industry
  • Good Industrial Practices Discipline, personal behavior, and personal safety Human skills Goal setting. Motivation, Time management, communications & Team work

Facilities, Equipment and System overview

  • Facilities Design/Layout
  • Water systems
  • Calibration
  • HVAC Design and validations
  • Qualification of equipment
  • Team work
  • Monitoring of clean room & filter validation
  • Process validations and cleaning validations
  • Water systems
  • Importance of Preventive maintenance of equipment

Quality Management System overview & cGMP

  • Schedule-M, WHO GMP, EU guidelines and USFDA guidelines.
  • Complaints and recall
  • Documentation practices, Quality evaluation & batch release
  • Quality assurance - Role and responsibilities
  • Contract production and analysis
  • Management responsibility: Quality overview
  • Batch reconciliation and Finished goods release
  • Self-inspection and quality audits Personnel Training
  • Sanitization and hygiene
  • Personal hygiene, Premises, equipment and materials

Quality Management System and its Elements

  • Change Control
  • Handling of non-conformance
  • Material systems
  • Packaging and labeling system
  • Deviation-(planned and unplanned)
  • Out of specification (OOS)
  • Production system
  • Incident
  • Market recalls
  • Laboratory control systems
  • CAPA
  • Market complaints
  • Facilities and equipment systems

Materials Control, Manufacturing, Packaging of Dosage forms and Manufacturing of API

  • Vendor Selection
  • Receipt, Sampling and Dispensing
  • Finished Product Warehouse management
  • cGMP of Pharmaceutical manufacturing
  • Evolution and Principles of cGMP, Schedule-M, WHO-GMP requirements, EU and USFDA guidelines
  • Manufacturing of Dosage Forms
  • cGMP complied manufacturing and documentation aspects including Environmental monitoring Cleaning (Equipment, Area, Environment), BMR, Process flow, in-process checks and FP analysis
  • Tablets
  • Capsules
  • Liquid Orals
  • Liquid Orals Parenteral/ Injectable/ Semisolids/ Ointments
  • GMP ICH Q7A
  • Drug substance development, scale-up, cGMP complied manufacturing and documentation aspects of API production
  • Unit operations
  • Handling of solvent
  • Waste management
  • Safety of personnel

Quality Control

  • Chemical and physical analysis
  • Application of microbiology in pharmaceutical
  • Deviations Planned and Unplanned
  • Instrumental analysis(GC, HPLC, UV, HPTLC, Dissolution)
  • Impurities (known and unknown) : ICH guideline
  • Post release monitoring-complaints, recalls
  • Reference Standards managements (RS and WRS)
  • Calibration of instruments
  • Stability studies application and guidelines
  • Good laboratory practices
  • Packing material analysis

Warehouse Management

  • Maintain the area according to the cGMP requirements with continuous monitoring.
  • Storage of materials according to the recommended storage conditions
  • Controlled materials to be upkeep as per the legal requirements
  • Receipt of material from approved source and labeling according to the status
  • Receipt information to the respective departments and sections i.e. QC, commercial or PPC
  • Documents like SOP, Bin Cards, Registers, schedules and etc to be upkeep as per cGMP requirements.
  • Verifications of the documents and physical verification of material against receipt of documents
  • Issuance of the required materials against approved BOM
  • Arrangements of materials according the status
  • Reconciliation and record up keeping of all materials in register or software