Pharma and Biopharma Quality System Refresher Course
Friday, January 11, 2013 from 10:00 AM to 11:30 AM (PST)
Palo Alto, CA
This 90-minute quality system requirements training will cover industry best practices, recent regulatory updates and practical tips on how pharmaceutical and biopharmaceutical companies can ensure their quality systems are in control and in compliance with agency expectations.
Why Should You Attend:
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.
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
- Needs Analysis
- Staff development requirements
- Pre-change analysis
- Post-change analysis
- Trigger events
- Response actions
- CAPA feedback and trending
- Audits processes and results
- Audit follow-up
- Ineffective corrective actions
- GMP document system
- GMP compliance records
- Record retention
- Quality complaints
- Adverse events and pharmacovigilance
- Problem response
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.