Good Documentation Practices for GMP Operations -Webinar By GlobalCompliancePanel by globalcompliancepane


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									GlobalCompliancePanel                                                 Your Gateway to Regulatory Compliance

Live Webinar on

Good Documentation Practices for GMP Operations

Date: Tuesday, March 19, 2013                                         Time: 10:00 AM PST | 01:00 PM EST

Duration: 60 Minutes             Location:   Online          Instructor: Kerry Paul Potter

Course "Good Documentation Practices for GMP Operations" has
been pre-approved by RAPS as eligible for up to 1.00 credits towards a               Register Now
participant's RAC recertification upon full completion.

Whether you work in production or in a laboratory or if you conduct investigations or finalize
product release, sound data and information is essential to success and compliance. To ensure
success and avoid those frustrating, embarrassing discussions of missing or doubtful data,
laboratory employees must follow good documentation practices.

According to the FDA, if it isn't written down, it didn't happen. As well, if it isn't written down
clearly, it didn't happen either. GMP compliance (21CFR, Part 211) requires the use of good
documentation practices.

Areas covered in the session:

    l   21CFR Part 211 and Eudralex references to documentation
    l   Correcting errors and omissions
    l   Dates and formats
    l   Meanings of initials and signatures
    l   Use of "NA"
    l   Comments and explanations
    l   Handling raw data (charts, strips, printouts)
    l   Blanks
    l   Entering numerical data

Who Will Benefit:                                         About Speaker

                                                          Kerry Paul Potter
    l   Production personnel                              President, Summit Consulting, Inc.
        (operators, supervisors)                          Kerry gained his pharmaceutical
    l   Laboratory personnel                              manufacturing experience during his
                                                          28-year career with Merck. His career
        (chemists, technicians,
                                                          spanned the areas of Quality
        supervisors)                                      Operations, Audits & Inspections,
    l   Batch record reviewers                            Laboratory, Human Resources, and
    l   QA Auditors of Production                         Learning & Development. More
                                                          specifically, his responsibilities
        and Laboratory Documents                          included quality management of
    l   Validation, Engineering                           laboratory assessment, site GMP lead
    l   Maintenance personnel                             auditor, FDA QSIT/Quality
                                                          Management System manager, 5S
        (mechanics, supervisors)
                                                          coordinator, GMP trainer (annual,
    l   Warehousing personnel
                                                          ongoing, new hire),   ...more

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