Training

(BUILDING CAPABILITIES FOR QUALITY)

We offer a variety of training to enhance the skills of your staff. The modules may be customized to suit your needs. Using the extensive industry experience, the modules are designed to impart practical training useful in the day-to-day job and at the same time, to broaden the subject knowledge and skills of the participants. These includes, but not limited to:

Quality Assurance /Compliance :

  • cGMP (Separate for API and Formulation)
  • Data Integrity Management
  • Good Documentation Practices
  • How to Face Regulatory Audits
  • Change Control Management
  • Deviation Management
  • How to Perform Investigation using Quality Tools
  • Effective CAPA Management System
  • Quality Risk Management
  • Role of Quality Unit
  • Validation
  • Hold Time Studies
  • Stability Study Management
  • Complaint, Return and Recall Management

Quality Control Laboratory:

  • Good Laboratory Practices
  • Elemental Impurities
  • Analytical Method Validations and Verification
  • OOS Investigation
  • Environmental Monitoring

Operations :

  • Warehouse Management System
  • Process Validation and Optimization

People Development :

  • Train the Trainers
  • Role of Supervisor
  • FDA Warning Letters Learning’s
  • 5’s The Japanese Model
  • SWOT Analysis