BEGIN:VCALENDAR PRODID:-//Tendenci - The Open Source AMS for Associations//Tendenci Codebase 12 MIMEDIR//EN VERSION:2.0 METHOD:PUBLISH BEGIN:VEVENT DTSTAMP:20240329T140415Z ORGANIZER: DTSTART:20130327T130000Z DTEND:20130327T210000Z LOCATION:Labtopia, Inc. TRANSP:OPAQUE SEQUENCE:0 UID:uid25@labtopiainc.com DESCRIPTION:--- This iCal file does *NOT* confirm registration.\r\nEvent details subject to change. ---\r\nhttps://www.labtopiainc.com/events/25/\r\n\r\nEvent Title: Laboratory Controls in the GMP/GLP Environment\r\nStart Date / Time: Mar 27, 2013 08:00 AM America/Chicago\r\nLocation: Labtopia, Inc.\r\nGoogle\r\nhttp://maps.google.com/maps?q=12929+Gulf+Freeway,+Suite+108,Houston,TX,77034\r\n\r\nForecast\nhttp://www.weather.com/weather/monthly/77034\r\n\r\nOverview:\r\nWhat controls should laboratories implement in an FDA regulated environment? This training course provides a thorough review of GMP/GLP requirements and current industry practice for labs which support clinical trials as well as those who provide quality control testing for commercial products.\r\nKey Session Topics:\r\n\r\nCalibration programs\r\nAnalytical method validation\r\nEquipment qualification\r\nControl of standards and reagents\r\nSOPs\r\nDocumentation practices\r\nOutsourcing\r\nTraining programs\r\nChange control\r\n\r\nThe speakers will also cover advanced topics which include out of specification (OOS) investigations, stability testing, and computer systems validation as it pertains to the laboratory.\r\nAs is apparent from the multitude of GMP warning letters related to laboratory compliance, laboratory controls is an area the FDA considers vital to drug product safety, quality, and efficacy. The laboratory plays a crucial role in the development and manufacture of drug products from the approval of submission documents to the release of the final product. Whether you work in paper based systems or electronic databases, this course will focus on effective ways to meet the requirements of the standards at any stage in the drug lifecycle.\r\nWho Should Attend:\r\nManagers or Personnel who are required to work in a GMP/GLP Environment--- This iCal file does *NOT* confirm registration.Event details subject to change. ---\r\n\r\n--- By Tendenci - The Open Source AMS for Associations ---\r\n X-ALT-DESC;FMTTYPE=text/html:
Overview:
What controls should laboratories implement in an FDA regulated environment? This training course provides a thorough review of GMP/GLP requirements and current industry practice for labs which support clinical trials as well as those who provide quality control testing for commercial products.
Key Session Topics:
The speakers will also cover advanced topics which include out of specification (OOS) investigations, stability testing, and computer systems validation as it pertains to the laboratory.
As is apparent from the multitude of GMP warning letters related to laboratory compliance, laboratory controls is an area the FDA considers vital to drug product safety, quality, and efficacy. The laboratory plays a crucial role in the development and manufacture of drug products from the approval of submission documents to the release of the final product. Whether you work in paper based systems or electronic databases, this course will \;focus on effective ways to meet the requirements of the standards at any stage in the drug lifecycle.
Who Should Attend:
Managers or Personnel who are required to work in a GMP/GLP Environment