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Change Control

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August 21 @ 12:00 pm - August 23 @ 4:30 pm

Philadelphia, United States

Implement Procedures and Discover Techniques that Have Immediate Impact

 

Managing changes in your Quality Management System is a FDA regulatory requirement and is one of the top issues cited in Warning Letters. KENX is excited to announce a conference the can dramatically CHANGE your strategy surrounding your change control program. KENX’s Change Control conference provides the knowledge and tools to develop, implement and maintain best-in-class procedures that impresses FDA investigators and makes an immediate impact to your organization and professional career. This program guides you through the process of developing, implementing and maintaining an effective change control program enterprise-wide.

 

 

Top 10 Reasons to Attend:

  • Know the regulations, guidance and warning letters
  • Build and manage a program that is inspection ever-ready
  • Recruit and train your change control committee
  • Learn how to use risk management and conduct impact assessments
  • Change control and configuration management
  • Discover documentation practices and effective quality management software
  • Identify and classify changes
  • Implement post approval change control protocols
  • Handle deviations in change control processes
  • Perform a quality system gap assessment

 

Personnel in the Following Environments Should Attend:

  • Validation
  • QA/QC
  • Engineering
  • Regulatory Affairs
  • Compliance
  • Manufacturing
  • Laboratory

 

 

 

This event is also appropriate to business development and sales managers that offer innovative solutions for change control, risk management, statistics and validation.

Agenda

  • 12:00
    Conference Registration
    Coffee and Lite Snacks On-the-Go
  • 1:15
    Chairperson’s Opening Remarks
  • 1:30
    Regulatory Intelligence—Staying Up to Speed on Regulatory Thinking
  • 2:15
    Observations and Responses—Interpreting and Responding to Regulatory Concerns
  • 3:00
    Afternoon Refreshment Break
  • 3:30
    Hot Topics for Regulatory Inspections – Change Control, Data Integrity, Metrics, QRM
  • 4:15
    Staying Compliant by Knowing and Understanding Warning Letter Trends
  • 5:00
    KENX/Temple Scholarship Award & Welcome Reception
  • 7:00
    Coffee and Lite Breakfast
  • 7:30-8:15
    Select Between Knowledge Exchange Sessions (1-2)
  • (1)
    Internal Auditor Master Class
    Share and overcome project management challenges
  • (2)
    Perform an Effective Quality Assessment
  • 8:30-12:00
    Knowledge Exchange Workshop
  • Build and Manage a Change Control Program that is Inspection Ever-Ready
  • 12:00
    Focus Group Luncheons (3-4)
  • (3)
    ICH Guidance and Why You Should Care
  • (4)
    Recruit and Train Your Change Control Committee
  • 1:15 – 2:45
    Knowledge Exchange Session
  • Implement Risk Management and Impact Assessments for Change Control
  • 2:45
    Afternoon Refreshment Break
  • 3:15-4:45
    Knowledge Exchange Session
  • Change Control and Configuration Management
  • 4:45
    Close of Day Two
  • 7:00
    Coffee and Lite Breakfast
  • 7:30-8:15
    Knowledge Exchange Breakfasts (5-6)
  • (5)
    Discover Documentation Practices and Effective Quality Management Software
  • (6)
    Identification and Classification of Changes
  • 8:30 – 10:00
    Knowledge Exchange Session
  • Managing Change Control Globally – A Case Study
  • 10:00
    Mid-Morning Refreshment Break
  • 10:30-12:00
    Knowledge Exchange Session
  • Post Approval Change Control Protocols
  • 12:00
    Focus Group Luncheons (7-8)
  • (7)
    Advanced Audit Professional Master Class
    • Program Management for Internal Auditors
  • (8)
    Dealing with Software Changes
  • 1:15-2:45
    Knowledge Exchange Session
  • Handling Deviations in Change Control Processes
  • 2:45
    Afternoon Refreshment Brea
  • 3:15 – 4:45
    Knowledge Exchange Session
  • Perform a Quality System Gap Assessment
  • 4:30
    Close of Conference

Faculty

  • Advisory Board Members

  • Coming Soon!

  • Faculty

  • Coming Soon!

Sponsors

Partners

Venue

Details

Start:
August 21 @ 12:00 pm
End:
August 23 @ 4:30 pm
Event Category:
Website:
https://www.kenx.org/events/change-control-aug-2018/

Venue

Doubletree by Hilton
237 South Broad Street
Philadelphia, PA 19107 United States
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Pricing & Registration

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