traceable calibrations, FDA regulations, FDA regulation training, FDA pharmaceutical regulation, 21 CFR Part 820, calibration standards, ISO calibration, FDA cGMP regulations, FDA compliance, FDA cGMP, paperless records, 21 CFR Part 11, calibration procedures, calibration traceability, quality calibration program, a paperless calibration department that meets biotech, pharmaceutical, and medical device reqirements, paperless calibration compliance for national and international standards and regulations, virtual calibration workshops

Calendar of Events 

 

 

MSC 2012
2012 MEASUREMENT SCIENCE CONFERENCE
March 19-23,2012

Tuesday, 20 March 2012

WORKSHOP T-01(Half Day): Calibration Records - From Hardcopy to Paperless - As Simple as 1, 2, 3!

Instructor: Jay L. Bucher, Ph.D.

Abstract: 12 years into the 21st Century, and the majority of calibration/metrology departments in biotech, pharmaceutical, and medical device companies are still collecting, storing, archiving and retrieving their calibration records in hardcopy format. For most departments, this places an enormous burden on them when it comes to filing, archiving, and retrieving records during audits. There is a very simple, cost effective and time saving solution - go paperless. You can still meet the FDA requirements under 21 CFR Part 11, Electronic Records, Electronic Signatures; and all of the calibration requirements that fall under the various 21 CFRs, including the compliance standards for ISO 9001:2008 & ISO 13485:2003. The learning objectives for this 4 hour tutorial are identifying the requirements; designing templates that meet those requirements; creating electronic templates that meet the regulations/standards; how to use/file/archive your records; and lessons learned about designing and using paperless calibration records.

 

WORKSHOP T-02(Half Day): Basic Training For New Calibration Technicians In The Biopharma & Medical Device Industries - Getting A Leg Up On The Competition!

Instructor: Jay L. Bucher, Ph.D.

Abstract: Most biopharma and medical device companies give calibration responsibilities to the lowest ranking member of their quality assurance department. That is how it used to be done, but this is the 21st Century and times have changed. A quality calibration program, no matter if all their test equipment is sent out for calibration/repair, or accomplished in-house, must include a training program which is a mandatory requirement under ISO standards and FDA regulations. This 4 hour tutorial provides the basic training needed to get started in the right direction for any calibration/metrology department. The learning objectives for this workshop are: The real meaning of calibration and traceability; What the regulations actually say; Calibration records and what to do with them; The five steps of a quality calibration program; and Surviving an audit/inspection.