BEGIN:VCALENDAR PRODID:NingEventWidget-v1 VERSION:2.0 METHOD:PUBLISH BEGIN:VTIMEZONE TZID:America/New_York X-LIC-LOCATION:America/New_York BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:19700308T020000 RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:19701101T020000 RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU END:STANDARD END:VTIMEZONE BEGIN:VEVENT UID:2140535:Event:63362 DTSTAMP:20260520T124004Z SUMMARY:Good Documentation Practices for GMP Operations DESCRIPTION:Overview: Whether you work in production or in a laborator y or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensur e success and avoid those frustrating, embarrassing discussions of mis sing or doubtful data, laboratory employees must follow good documenta tion 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 ha ppen 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 othe r handwritten entries. Personnel who work with documentation must be i nformed of these requirements, recognize their significance to their j ob and be aware of the consequences of non-compliance. During this 1-h our webinar, we will review the Good Documentation Practices plus demo nstrate examples of these practices (both good and bad!) as they apply to the pharmaceutical arena.Why you should attend: The Learning Objec tives of this presentation include:\nDiscover what the regulations say about documentation practices\nLearn what your signature and/or initi als mean on a document \nSee how to correct errors and omissions in d ata entry \nLearn \"Do's\" and \"Don'ts\" of documentation practices\ nLearn how to attach raw data to records\nReview rounding and limit ex pression determinations\n\nAreas Covered in the Session:\n\n21CFR Part 211 and Eudralex references to documentation\nCorrecting errors and o missions\nDates and formats\nMeanings of initials and signatures\nUse of \"NA\"\nComments and explanations\nHandling raw data (charts, strip s, printouts)\nBlanks\nEntering numerical data\n\nWho Will Benefit:\n\ nProduction personnel (operators, supervisors)\nLaboratory personnel ( chemists, technicians, supervisors)\nBatch record reviewers\nQA Audito rs of Production and Laboratory Documents\nValidation, Engineering\nMa intenance personnel (mechanics, supervisors)\nWarehousing personnel\n\ n\n\n\nKerry gained his pharmaceutical manufacturing experience durin g his 28-year career with Merck. His career spanned the areas of Quali ty Operations, Audits & Inspections, Laboratory, Human Resources, and Learning & Development. More specifically, his responsibilities includ ed quality management of laboratory assessment, site GMP lead auditor, FDA QSIT/Quality Management System manager, 5S coordinator, GMP train er (annual, ongoing, new hire), OSHA regulations and Process Safety Ma nagement training, as well as internal and external public relations.  \n\nQuick Contact:\nGlobalCompliancePanel USA Phone:800-447-9407webin ars@globalcompliancepanel.comhttp://www.globalcompliancepanel.comEvent Link - http://bit.ly/1blYnmT\n\n\n\n\n\nFor more information visit h ttps://medtechiq.ning.com/events/good-documentation-practices-for-gmp- operations DTSTART;TZID=America/New_York:20140324T100000 DTEND;TZID=America/New_York:20140324T110000 CATEGORIES:webinar, pharma, medical, clinical, health LOCATION:Online Event WEBSITE:http://bit.ly/1blYnmT URL:http://bit.ly/1blYnmT CONTACT:8004479407 ORGANIZER;CN="John Robinson":https://medtechiq.ning.com/profile/JohnRo binson ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/ file/get/2562011838?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob inson":https://medtechiq.ning.com/profile/JohnRobinson END:VEVENT END:VCALENDAR