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Online Webinar
19 Mar 2013

Good Documentation Practices for GMP Operations

Good Documentation Practices for GMP Operations - Webinar By GlobalCompliancePanel

Overview: 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. 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 these requirements, recognize their significance to their job and be aware of the consequences of non-compliance. During this 1-hour webinar, we will review the Good Documentation Practices plus demonstrate examples of these practices (both good and bad!) as they apply to the pharmaceutical arena.Why you should attend: The Learning Objectives of this presentation include:Discover what the regulations say about documentation practicesLearn what your signature and/or initials mean on a document See how to correct errors and omissions in data entry Learn "Do's" and "Don'ts" of documentation practicesLearn how to attach raw data to recordsReview rounding and limit expression determinationsAreas Covered in the Session:21CFR Part 211 and Eudralex references to documentationCorrecting errors and omissionsDates and formatsMeanings of initials and signaturesUse of "NA"Comments and explanationsHandling raw data (charts, strips, printouts)BlanksEntering numerical dataWho Will Benefit:Production personnel (operators, supervisors)Laboratory personnel (chemists, technicians, supervisors)Batch record reviewersQA Auditors of Production and Laboratory DocumentsValidation, EngineeringMaintenance personnel (mechanics, supervisors)Warehousing personnelUSAGlobalCompliancePanel,Livermore Common, Fremont, CA, 94539USA Phone:800-447-9407Fax: 302-288-6884


19 Mar 2013 @ 10:00 am

19 Mar 2013 @ 11:00 am

Duration: 1 hours

Timezone: GMT -8:00


Online Webinar


English en

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GlobalCompliancePanel (deactivated)

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