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:470913 DTSTAMP:20260523T140653Z SUMMARY:Good Documentation Practice and Record Keeping Regulations (FD A & EMA) DESCRIPTION:In this webinar, we will discuss the definition, purpose, importance of GDP, General rules of GDP, GDP as it applies to laborato ry notebook documentation, US Pharmacopeia General Chapter <1029>, and introduction “Good Documentation Guidelines”. We will also briefl y introduce you to the European Union (EU) GDP, and its enforcement al ong with some observation samples from FDA.\n\nWhy Should You Attend:\ nGood documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment a s a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorde d and verified.\nThis 60-min Webinar covers the essentials of GDP, its definition, purpose, and importance. Then expands on general rules an d principles of GDP (US & EU), General tips for Laboratory Notebook do cumentation and finally discussing GDP enforcement by regulatory bodie s in different countries with some examples of FDA citations.\nIf you are involved in any product manufacturing, knowing GDP regulations is a must for you. It prevents a lot of errors and minimizes the chance o f being spotted by the regulatory bodies in their audits.\n\nAreas Cov ered in the Webinar:\nThe outline of this training includes:\n\nDefini tion, Purpose, and Importance\nGeneral Rules and Principles of GDP\nRe quirements of Records\nGeneral Tips in GDP:\nSignature / initial and t he meaning\nCopying records\nDocument maintenance\nRecording the time and date\nCorrection of errors\nRounding rules\nBack dating\nMissing d ata\nVoiding / cancelling records\n\n\n\n\n\nFrequently Asked Question s:\n\nCan you explain why blue pen is not acceptable?\nAnything specif ic in document retention requirements in EU?\nIn the U.S., how long do documents have to be kept after the completion of a project/ clinical trial?\nRelated to 'what to do in case of errors': when mentioning th e reason for error do you notate and include explanation it on the bot tom?\nCan paper documents be destroyed if electronic copies are kept o f documentation?\nWhat kind of original documents can’t be usually d estroyed?\n\n\nWho Will Benefit:\nThis webinar is applicable to the Me dical Device and Pharmaceutical industries. Titles includes:\n\nAnybod y who works in a regulated environment\nManufacturing & Production Per sonnel / Managers\nResearch and Development Personnel (R&D) / Managers \nQuality Assurance & Quality Control Personnel / Managers\nLaboratory Personnel / Managers\nValidation Specialists\nClinical trial personne l\nProject Managers\n\n\nFor more information visit https://medtechiq. ning.com/events/good-documentation-practice-and-record-keeping-regulat ions-fda DTSTART;TZID=America/New_York:20220111T100000 DTEND;TZID=America/New_York:20220111T130000 CATEGORIES:seminae LOCATION:online WEBSITE:https://www.complianceonline.com/good-documentation-practice-a nd-record-keeping-regulations-webinar-training-705583-prdw?channel=Med Tech%20I.Q URL:https://www.complianceonline.com/good-documentation-practice-and-r ecord-keeping-regulations-webinar-training-705583-prdw?channel=MedTech %20I.Q CONTACT:8887172436 ORGANIZER:Complianceonline ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0 /file/get/9974761688?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc eOnline:https://medtechiq.ning.com/profile/Referral512 END:VEVENT END:VCALENDAR