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
- 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
- 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
- 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
- Auxiliary Systems
- 2:45 PM -3:00 PM Break
- 3:00 PM -4:00 PM
- Auxiliary Systems – Cont.
- Engineering Change Control
- Replacement Parts
- Contractor Control
- Auxiliary Systems – Cont.
- 4:00 PM -4:30 PM Q&A
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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