Master Quality Assurance for Pharma Industry

Instrumentation Training Includes:

• Regulatory Guidelines and Compliance
  Understanding key regulatory frameworks such as WHO, FDA, EU-GMP, and ICH Q10.
• cGMP, GLP, GDP Compliance
  Mastering Current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and Good Documentation Practices (GDP).
• 21 CFR Part 11 Training
  Deep insights into electronic records and electronic signatures compliance for pharmaceutical industries.
• ICH Q7 Compliance
  Learning about Good Manufacturing Practices for Active Pharmaceutical Ingredients (APIs).
• SOP Preparation and Management
  Drafting, implementing, and reviewing Standard Operating Procedures (SOPs) to maintain operational integrity.
• Change Control and Handling Non-Conformance
  Efficient management of change controls, non-conformance reports, and continual process improvement.
• Incident, Deviation, and Market Complaint Handling
  Practical training on handling deviations, incidences, OOS (Out of Specification) results, and OOT (Out of Trend) results, ensuring timely corrective actions.
• In-Process Quality Assurance (IPQA)
  Real-time monitoring and controls during production activities.
• Internal Audits and Self-Inspection
  Preparing for internal audits, performing gap assessments, and mock regulatory inspections.
• Quality Management Systems (QMS)
  Developing a robust QMS including preparation and control of Quality Documents, SOPs, and record maintenance.
• Document Control and Data Integrity
  Managing controlled documents and ensuring data integrity compliance according to global standards.

This comprehensive approach ensures you're fully trained in every critical aspect of pharmaceutical QA.