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Pharma and Biopharma Quality System Refresher Course


Friday, January 11, 2013 from 10:00 AM to 11:30 AM (PST)

Palo Alto, CA

Pharma and Biopharma Quality System Refresher Course

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Ticket Type Sales End Price Fee Quantity
Online Registration Ended $249.00 $14.69

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Event Details

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.

Learning Objective:

Attendees will gain a thorough understanding of Pharmaceutical and Biopharmaceutical Quality Systems and the associated requirements.

Areas Covered in the Seminar:


  1. Quality Management System (QMS)
    • QMS elements
    • QMS requirements
  2. Quality Unit (site) Management
  3. Risk Management
  4. Training and personnel qualification
    • Needs Analysis
    • Staff development requirements
  5. Change Control and Management
    • Pre-change analysis
    • Post-change analysis
  6. Investigations and corrective and preventive action (CAPA)
    • Trigger events
    • Response actions
    • CAPA feedback and trending
  7. Audits and self-inspections
    • Audits processes and results
    • Audit follow-up
    • Ineffective corrective actions
  8. Documents and records management
    • GMP document system
    • GMP compliance records
    • Record retention
  9. Product quality complaints vs. adverse event reports
    • Quality complaints
    • Adverse events and pharmacovigilance
    • Problem response
  10. Product trend requirements
  11. Supplier and contractor quality management


For Registration:

Have questions about Pharma and Biopharma Quality System Refresher Course? Contact ComplianceOnline

When & Where

Online Webinar
2600 E. Bayshore Road
Palo Alto, CA 94303

Friday, January 11, 2013 from 10:00 AM to 11:30 AM (PST)

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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.




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