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  • Validating Manufacturing Control Systems (MCS) to Meet
    Compliance Requirements

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Tuesday - May 21, 2013 10:00 AM
  • End Time:
  • Tuesday - May 21, 2013 11:30 AM
  • Location:
  • Online
  • This webinar will cover the unique validation requirements and compliance issues of the most critical system in your supply chain viz. the manufacturing control system.

    Why Should You Attend:

    A review of recent citations reveals that auditors are inspecting how companies are validating to manage the compliance risks of manufacturing control systems which are automating manufacturing operations such as in production management, generation of production records and EBRs, equipment usage history, operator actions, alarm handling etc.

    This basic to intermediate level webinar is designed to address the hot button issues for auditors of automated manufacturing control systems. It is presented by a process automation regulatory expert with over 35 years of experience. At the conclusion of this webinar, you will be able to understand the compliance issues of your most critical system in your supply chain viz. the manufacturing control system. This system has been at the heart of most of the consent decrees.

    Areas Covered in this Webinar:

    1. What core system functions do regulators consider as regulatory impacting
    2. What are the system’s three broad functions that regulators expect to be tightly integrated.
    3. What applications of these systems must meet 21 CFR part 11 requirements.
    4. How are compliance issues addressed through use of current design standards.
    5. What are the unique validation requirements for these systems.
    6. What are the 5 areas of such systems that inspectors assess for compliance.
    7. Techniques to strike a balance between business and compliance requirements.
    8. Inspection trends with examples of some recent 483s and WL
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