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DTSTART:19700308T020000
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UID:2140535:Event:66910
DTSTAMP:20260523T080314Z
SUMMARY:Webinar on Good Documentation Practices for GxP Compliance
DESCRIPTION:Overview: Documentation is essential for good science. Th
 is is especially true in life sciences where FDA and other health auth
 ority regulations impose a special recordkeeping burden. In these indu
 stries, documentation serves both the scientific and compliance needs,
  and Good Documentation Practices (GDPs) are the set of activities tha
 t enable you to record your data and hand-written entries in a legible
 , traceable and reproducible manner.\nWhy should you Attend: \nWhethe
 r you work in production or in a laboratory or if you conduct investig
 ations or finalize product release, sound data and information is esse
 ntial to success and compliance. To ensure success and avoid those fru
 strating, embarrassing discussions of missing or doubtful data, all em
 ployees must follow good documentation practices.The use of GDP allows
  companies to comply with regulatory requirements such as Good Laborat
 ory Practices (GLP), Good Manufacturing Practices (GMP) or the applica
 ble quality management system (for example, ISO 13485, 21 CFR parts 11
 ,211,312,and 820), or Good Clinical Practices (GCP).Documentation that
  is used in support of manufacturing, laboratory and clinical practice
 s should adhere to GDP.According to the FDA, if it isn't written down,
  it didn't happen. As well, if it isn’t written down clearly, it did
 n’t happen either. Good Documentation Practices describe the require
 d activities and steps to use when recording data and other handwritte
 n entries. Personnel, who work with documentation must be informed of 
 these requirements, recognize their significance to their job and be a
 ware of the consequences of non-compliance. Areas Covered in the Sess
 ion:\n\nDocument System\nWhat is Documentation?\nType of Documents\nGo
 od Documentation Practices\nGood Documentation requirements\nDocumenta
 tion Processing and Control\nGuidance documents for GDP\n\nWho Will Be
 nefit:\n\nAnyone who authors, reviews, and audits documents and record
 s in FDA-regulated pharmaceutical, biotechnology, and medical device i
 ndustries\nClinical research associates\nManufacturing/Production pers
 onnel\nLaboratory personnel\nResearch and Development associates\nDocu
 ment Control associates\nBatch record reviewers\nQA/QC specialists\nVa
 lidation engineers\nQuality Assurance auditors\nRegulatory Compliance 
 Associates and Managers\n\nSpeaker Profile:\n\nAlla Teresh ASQ CQA, h
 as over 11 years of comprehensive experience in documentation audit an
 d management within the medical device industry. During her practice, 
 she designed and implemented a document control system for a startup c
 ompany that was audited for and awarded an FDA medical PMA and 510K, C
 E Mark Approval for distribution in Europe. Her skills include a high 
 level of proficiency in conducting technical reviews and managing qual
 ity system documentation.\nContact Detail:\nNetZealous - Compliance4Al
 l,161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1
 -800-447-9407 Email: support@compliance4All.comhttp://www.compliance4a
 ll.com/Event Link : http://bit.ly/1Kf003R\n\n\n\nFor more information
  visit https://medtechiq.ning.com/events/webinar-on-good-documentation
 -practices-for-gxp-compliance
DTSTART;TZID=America/New_York:20151014T100000
DTEND;TZID=America/New_York:20151014T110000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:http://bit.ly/1Kf003R
URL:http://bit.ly/1Kf003R
CONTACT:18004479407
ORGANIZER;CN="Adam Fleming":https://medtechiq.ning.com/profile/Complia
 nce4all
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562012364?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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