CALIBRATION - The
Risk Based Approach
to Calibration
Management

Conference Date: 19 Jan 2010-02 Mar 2010
Conference Ref: M1-6010
Fee: £1220 + VAT
Venue: Millennium Gloucester Hotel, London

An Opportunity to Preview the New ISPE GAMP Good Practice Guide due out in 2010

This seminar will provide an interactive approach to understanding the new GAMP Good Practice Guide:
The Guide offers a pragmatic approach, based on a criticality assessment, to provide effectiveness and regulatory compliance as cost effectively as possible.

Revision of the Calibration Management Good Practice Guide:- Update and Status:

• Focused calibration effort concentrating on regulatory risks and patient safety
• Software systems for supporting calibration both as scheduling and data record tools
• Internal and external auditing of systems and the use of supplier systems and documentation
• Guidance on the application of ‘errors of uncertainty’ calculations and Assumptions
• Physical labelling and tagging schemes
• Risk based interval setting
• Reference standards and traceability
• Tolerance, Alert and Action limits
• Adjustment (within range, out of range)

Currently Industry/Regulatory Thinking

• Alignment with GAMP 5, ICH 8/9/10, VPCS and other ISPE initiatives including C&Q
• Regulatory changes in SOP requirements, contractor competency assessment
• Documentation sign off (paper or electronic), verification vs qualification

Workshops on:

• Documentation, Auditing and Good Practice
• Criticality Risk and Impact Assessment

Click here to register for this important event.