Marcus McNeely, Business Process Analyst at Blue Mountain Quality Resources, will be presenting “Healthcare Metrology Program Documentation Best Practices – An Industry Perspective” at the Measurement Science Conference on March 20th, 2013 in Anaheim CA. This half day tutorial session will cover current practices on Calibration Master Plans and Sub-Documentation.
Also sponsored by NCSLI Healthcare Metrology Committee, this session will cover:
- Quality System Inspection Technique
- Equipment / Process Relationships
- A Typical System Lifecycle
- The Calibration Program
- Calibration Master Plans
- Equipment Categorization
- Equipment Registration
- Numbering and Labeling
- Equipment IDs
- Process Versus Calibration Limits
- Guard Banding Process Limits
- Calibration Frequencies
- Calibration SOPs
- Master History Records
- Calibration Certificates
- Tolerance Logs
- Calibration Frequency Logs
- Calibration Failures of Critical Instruments
- OOT Impact on Business
- OOT Investigations
- Change Control SOPs
McNeely has been in the field of Biotech and Pharmaceutical metrology and validation for over 17 years. He has managed GMP/GLP/GSP biotech calibration programs in both manufacturing and laboratory environments, in addition to involvement in various biopharmaceutical quality programs. He has also been responsible for GMP, calibration and systems training for large groups and individuals worldwide.
About Blue Mountain Quality Resources, Inc.
Blue Mountain Quality Resources sets the standard for regulatory asset management software and services in the Life Sciences industry. Their flagship EAM offering, Blue Mountain RAM, integrates functionality for the full cycle of maintenance operations with world-class calibration management. Founded in 1989, the firm offers solutions for Biotech, Medical Device and Pharmaceutical companies ranging from small startups to the Fortune 500.