Attend this seminar to learn the concepts for developing compliance programs to maintain the validated state. These programs are included in the Six-system Inspection Model of the Facility portion of the FDA Guidance For Industry – Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations. Topics include GMP Maintenance, Calibration, Pest Control, Replacement Parts, and Project Engineering/Engineering Document Control.

Learning Objectives:

  • To understand the ongoing requirements of facilities, maintenance, and calibration systems to maintain the validated state of equipment and facilities.
  • Understand requirements for a complaint Project Engineering Program
  • Instituting a Compliant Maintenance Program
    • Developing Preventive Maintenance Regimen
    • Handling Demand (Corrective) Maintenance Requirements
    • Handling late PM assignments
    • Maintenance Metrics
Seminar Fee Includes:
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar
  • Instituting a Complaint Calibration Program
    • Developing Calibration Parameters:
      • Classifications
      • Limits and tolerances
      • Frequency of Calibration
    • Out-of-Tolerance responses
    • Calibration Metrics
  • Ensuring an adequate Pest Control Program
    • Location and types of Pest Control Devices
    • Monitoring, reporting and responding to Pest Control issues
  • Requirements for replacement parts
    • Types of replacement parts
    • Approving Functional Equivalent (Like-for-Like) Parts
  • Technical Document Control
  • Storing and controlling Manuals and Drawings

Areas Covered :

GMP Facilities, Project Engineering, Maintenance, and Calibration

Who will Benefit:

Operations, Engineering, Maintenance, Calibration and support personnel in the FDA regulated industry

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 08.59 AM – Registration, Meet & Greet
  • 09.00 AM - Session Start Time
  • 9:00 AM -10:00 AM
    • Seminar objectives review, expectations and scope.
    • Introduction/The Basis
  • 10:00 AM -10:45 AM
    • Calibration Program Intro
    • Risk Based Approach to Classifying Instruments
    • Setting Limits & Tolerances
  • 10:45 AM -11:00 AM Break
  • 11:00 AM -12:00 PM
    • Setting Limits & Tolerances – Cont.
    • Test Accuracy Ratios
    • Incorporating the Quality Unit in Calibration
  • 12:00 PM -1:00 PM Lunch
  • 1:00 PM -2:00 PM
    • Calibration System SOPs
    • Specific Calibration Procedures
  • 2:00 PM -2:45 PM
    • Calibration Test Points and Rationale
    • Developing Device Specific SOPs
  • 2:45 PM -3:00 PM Break
  • 3:00 PM -4:00 PM
    • Contractor SOPs
    • SOP Review and Approvals
    • Out-of-Tolerance Response
  • 4:00 PM -4:30 PM
    • Laboratory Instruments
    • Control of Standards
Day 02(8:30 AM - 4:30 PM)
  • 09.00 AM - Session Start Time
  • 9:00 AM -10:00 AM
    • Project Engineering Approach.
    • Introduction/The Basis
  • 10:00 AM -10:45 AM
    • Maintenance Program
    • Preventive Maintenance Regimen Development
    • Incorporating the Quality Unit in Maintenance
  • 10:45 AM -11:00 AM Break
  • 11:00 AM -12:00 PM
    • Demand/Corrective Maintenance Requirements
    • Out-of-Frequency Reporting
  • 12:00 PM -1:00 PM Lunch
  • 1:00 PM -2:45 PM
    • Auxiliary Systems
      • Pest Control
      • Cleaning
      • Drawing Control
  • 2:45 PM -3:00 PM Break
  • 3:00 PM -4:00 PM
    • Auxiliary Systems – Cont.
      • Engineering Change Control
      • Replacement Parts
      • Contractor Control
  • 4:00 PM -4:30 PM Q&A
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Joseph T Busfield

Joseph T Busfield
Principal, Pharmaceutical Technical Services

Experienced cGMP compliance consultant, helping organizations achieve or maintain compliance in engineering, facilities, maintenance, calibration, equipment qualification, validation, and related operational areas. Assisted in remediation efforts at some 14 plus Consent Decree sites and numerous Warning Letter and 483 remediation efforts as well as organizations wanting to put robust systems in place to avoid regulatory distress.

Specialties: GMP Engineering, Operations, and Facility Programming, e.g. Project Engineering, Maintenance, and Calibration programming, Engineering Change Control, Facility & Equipment Qualification, Pest Control, etc.

Extensive seminar/training experience in areas of expertise, including Compliant GMP Maintenance, Compliant GMP Calibration, Facility & Equipment Quality Systems, and GMP Project Engineering.

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Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]

Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

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We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

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After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

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    For more details and other sponsorship options at this event, please contact Event Manager: [email protected] or call: +1-650-238-9656

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