Pharma and Biopharma Quality System Refresher Course
Why Should You Attend:
Quality System Training is mandatory per regulatory agencies, no matter where in the world you want to market your medicinal products including Pharmaceuticals and Biopharmaceuticals. Regulatory agencies are looking into seeing whether companies’ Quality Systems are in control during License Renewal Inspections, Cause Inspections, System Based Inspections and Pre-approval (PAI) Inspections. Many companies are getting Warning Letters and or Consent Decree due to violations in Quality Systems requirements.
This session will train you in one of the eight major modules of ASQ cGMP Certification Training Program for Pharma and Biopharma. The presenter will share new information and industry best practices and provide ample opportunity to ask questions.
Attendees are highly encouraged to submit pre training questions. The instructor will make every effort to cover or answer most of the questions during the presentation or during Q&A the session.
Learning Objective:
Attendees will gain a thorough understanding of Pharmaceutical and Biopharmaceutical Quality Systems and the associated requirements.
Areas Covered in the Seminar:
- Quality Management System (QMS)
- QMS elements
- QMS requirements
- Quality Unit (site) Management
- Risk Management
- Training and personnel qualification
- Needs Analysis
- Staff development requirements
- Change Control and Management
- Pre-change analysis
- Post-change analysis
- Investigations and corrective and preventive action (CAPA)
- Trigger events
- Response actions
- CAPA feedback and trending
- Audits and self-inspections
- Audits processes and results
- Audit follow-up
- Ineffective corrective actions
- Documents and records management
- GMP document system
- GMP compliance records
- Record retention
- Product quality complaints vs. adverse event reports
- Quality complaints
- Adverse events and pharmacovigilance
- Problem response
- Product trend requirements
- Supplier and contractor quality management
- Supplier quality systems
- Supplier controls
- Supplier evaluation
