BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//OTRADI - ECPv6.18.2//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:OTRADI
X-ORIGINAL-URL:https://www.otradi.org
X-WR-CALDESC:Events for OTRADI
REFRESH-INTERVAL;VALUE=DURATION:PT1H
X-Robots-Tag:noindex
X-PUBLISHED-TTL:PT1H
BEGIN:VTIMEZONE
TZID:America/Los_Angeles
BEGIN:DAYLIGHT
TZOFFSETFROM:-0800
TZOFFSETTO:-0700
TZNAME:PDT
DTSTART:20190310T100000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0700
TZOFFSETTO:-0800
TZNAME:PST
DTSTART:20191103T090000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0800
TZOFFSETTO:-0700
TZNAME:PDT
DTSTART:20200308T100000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0700
TZOFFSETTO:-0800
TZNAME:PST
DTSTART:20201101T090000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0800
TZOFFSETTO:-0700
TZNAME:PDT
DTSTART:20210314T100000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0700
TZOFFSETTO:-0800
TZNAME:PST
DTSTART:20211107T090000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200727T080000
DTEND;TZID=America/Los_Angeles:20200727T120000
DTSTAMP:20200716T161002Z
CREATED:20200706T175924Z
LAST-MODIFIED:20200716T161002Z
UID:10000203-1595836800-1595851200@www.otradi.org
SUMMARY:BioPro: "cGMP" current Good Manufacturing Practices
DESCRIPTION:8 hour class delivered in two 4-hour modules\, 7/27 and 7/28 from 8 a.m. to 12 p.m. \nOverview:\nBuilding upon Overview of FDA and Quality Systems Overview courses\, this course goes beyond the basics and uses interactive exercises to understand and apply current Good Manufacturing Practice (cGMP) regulations for pharmaceutical\, biopharmaceutical and medical device industries. This course will dive into the details of 21 CFR Parts 210\, 211\, & 820\, ICHQ7\, and the EU GMP guidelines. Participants will benefit from real world examples and lessons learned to use risk-based and scientific principles to ensure product quality throughout the production lifecycle. This course will guide participants through the six system inspection model: Quality Systems\, Materials\, Packaging and Labeling\, Production\, Facilities & Equipment\, and Laboratory Controls\, to provide them with appropriate strategies for ensuring compliance. \nBy the end of the course\, participants will be able to: \nApply cGMPs to their specific job responsibilities beyond the basic elements.\nEstablish and maintain a quality system that builds quality into the product and allows for implementation of continual improvement.\nUnderstand and interpret cGMPs in a practical manner to be able to apply the “right-sized” Quality Systems and GMPs to fit the specific environment\, taking into account factors such as scope of operations\, complexity of processes\, and appropriate use of finite resources.\nDiscuss specific requirements and strategies for compliance with 21 CFR Parts 210\, 211\, & 820\, ICHQ7\, and the EU GMP guidelines.\nDefine each of the six-system elements: Quality Systems\, Materials\, Packaging and Labeling\, Production\, Facilities & Equipment\, and Laboratory Controls\nCourse Outline: \nQuality Systems\nNote: Other courses in the certificate program will provide greater detail in Quality Systems such as CAPA\, Change Control\, Deviation Management\, and Quality Risk Management.\nOrganization and Personnel\nDocumentation (Records and Reports)\nControl of Materials\nProduction Controls\nFacilities and Equipment\nPackaging and Labeling\nLaboratory Controls \nWho Should Attend:\nQuality assurance\, quality control\, regulatory affairs\, validation\, manufacturing\, technical support\, IT\, supply chain\, and engineering professionals in the pharmaceutical\, biopharmaceutical\, or medical device industry.\nAll levels of management who require a refresher course to stay current with GMP regulations and learn from case studies. Service providers and vendors who serve pharmaceutical\, biopharmaceutical or medical device industry clients. \nPrerequisites:\nNo prerequisites.
URL:https://www.otradi.org/event/cgmp-current-good-manufacturing-practices/2020-07-27/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200728T080000
DTEND;TZID=America/Los_Angeles:20200728T120000
DTSTAMP:20200716T161002Z
CREATED:20200706T175924Z
LAST-MODIFIED:20200716T161002Z
UID:10000204-1595923200-1595937600@www.otradi.org
SUMMARY:BioPro: "cGMP" current Good Manufacturing Practices
DESCRIPTION:8 hour class delivered in two 4-hour modules\, 7/27 and 7/28 from 8 a.m. to 12 p.m. \nOverview:\nBuilding upon Overview of FDA and Quality Systems Overview courses\, this course goes beyond the basics and uses interactive exercises to understand and apply current Good Manufacturing Practice (cGMP) regulations for pharmaceutical\, biopharmaceutical and medical device industries. This course will dive into the details of 21 CFR Parts 210\, 211\, & 820\, ICHQ7\, and the EU GMP guidelines. Participants will benefit from real world examples and lessons learned to use risk-based and scientific principles to ensure product quality throughout the production lifecycle. This course will guide participants through the six system inspection model: Quality Systems\, Materials\, Packaging and Labeling\, Production\, Facilities & Equipment\, and Laboratory Controls\, to provide them with appropriate strategies for ensuring compliance. \nBy the end of the course\, participants will be able to: \nApply cGMPs to their specific job responsibilities beyond the basic elements.\nEstablish and maintain a quality system that builds quality into the product and allows for implementation of continual improvement.\nUnderstand and interpret cGMPs in a practical manner to be able to apply the “right-sized” Quality Systems and GMPs to fit the specific environment\, taking into account factors such as scope of operations\, complexity of processes\, and appropriate use of finite resources.\nDiscuss specific requirements and strategies for compliance with 21 CFR Parts 210\, 211\, & 820\, ICHQ7\, and the EU GMP guidelines.\nDefine each of the six-system elements: Quality Systems\, Materials\, Packaging and Labeling\, Production\, Facilities & Equipment\, and Laboratory Controls\nCourse Outline: \nQuality Systems\nNote: Other courses in the certificate program will provide greater detail in Quality Systems such as CAPA\, Change Control\, Deviation Management\, and Quality Risk Management.\nOrganization and Personnel\nDocumentation (Records and Reports)\nControl of Materials\nProduction Controls\nFacilities and Equipment\nPackaging and Labeling\nLaboratory Controls \nWho Should Attend:\nQuality assurance\, quality control\, regulatory affairs\, validation\, manufacturing\, technical support\, IT\, supply chain\, and engineering professionals in the pharmaceutical\, biopharmaceutical\, or medical device industry.\nAll levels of management who require a refresher course to stay current with GMP regulations and learn from case studies. Service providers and vendors who serve pharmaceutical\, biopharmaceutical or medical device industry clients. \nPrerequisites:\nNo prerequisites.
URL:https://www.otradi.org/event/cgmp-current-good-manufacturing-practices/2020-07-28/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
END:VCALENDAR