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From GlobalCompliancePanel
Master Production Record Requirement - Webinar By GlobalCompliancePanel
This program will address the 21CFR and Eudralex Volume 4 requirements and interpretation, as well as FDA Guidance regarding the creation, review and approval, and control of Master Production Records.
Tuesday, December 20, 2011
10: 00 AM PST | 01: 00 PM EST
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Master Production Record Requirements - Webinar By GlobalCompliancePanel
...Eudralex Volume 4 requirements and interpretation, as well as FDA Guidance regarding the creation, review and approval, and control of Master Production Records.
The material will enable attendees to establish a consistent approach to the design of MPR, including cover page content, instructions, processing requirements and limits, and signature expectations. (There will also be a note on
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Good Documentation Practices for Laboratory Operations - Webinar By GlobalCompliancePanel
...didn't happen either. GMP compliance (21CFR, Part 211 and Eudralex, Volume 4) requires the use of good documentation practices. These practices apply to all pharmaceutical manufacturing and support areas. Good Documentation Practices describe the required activities and steps to use when recording data and other handwritten entries. Personnel, who work with documentation must be informed of
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Requirements of the Master Production Record - Webinar By GlobalCompliancePanel
...Eudralex Volume 4 requirements and interpretation, as well as FDA Guidance regarding the creation, review and approval, and control of Master Production Records.
The material will enable attendees to establish a consistent approach to the design of MPR, including cover page content, instructions, processing requirements and limits, and signature expectations. (There will also be a note on
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Good Documentation Practices for GMP Operations - Webinar By GlobalCompliancePanel
...Areas Covered in the Session:
* 21CFR Part 211 and Eudralex references to documentation
* Correcting errors and omissions
* Dates and formats
* Meanings of initials and signatures
* Use of "NA"
* Comments and explanations
* Handling raw data (charts, strips, printouts)
* Blanks
* Entering numerical data
Who Will Benefit:
* Production
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