A Quality Calibration Program for
Biotech and Pharmaceutical Companies:
Meeting the FDA requirements
for traceable calibration;
also included in this
Paperless Records -
Designing and Creating Your
Own Electronic Forms.
Course topics include:
Overview
The criticality of calibration
A short history of calibration
Background of
the
FDA
Requirements
21 CFR Part 820.72 (FDA – QSR)
21 CFR Part 820.25 (Training requirements)
21 CFR Parts: 58, 110, 121, 145, 211, and 606
ISO 9000, ISO 13485
A Quality Calibration Program
Calibration procedures – writing them
Calibration procedures – using them
Calibration records
Out of tolerance procedures
Managing a Quality Calibration Program
Setting up and implementing a new metrology department
Managing a QCP through best practices/lessons learned
Paperless Records using MS Word
Formatting using MS Word
How to use Word and the Form tools
Making templates
Making pre-filled templates
Protecting your forms
Using your forms – cosigning and re-protection
Assist attendees with their individual requirements using MS Word
Paperless Records using Adobe Acrobat 8.0 Pro
Using the various form tools in Adobe Acrobat
Setting up digital signatures
Lessons learned using Adobe Acrobat
Assist attendees with their individual requirements using Adobe
Acrobat
Attendees receive a handout booklet
on a QCP for Biotech and
Pharmaceutical companies, a video CD, and
a handout of the book -
Paperless Records
This workshop fulfills training requirements
for ISO and the FDA, and is worth
1.6 RUs towards ASQ CCT recertification.
Dates and times TBD.
Workshops can also be given
in-house for 5 or more attendees.
Call or email for details.