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UID:MEC-c042f4db68f23406c6cecf84a7ebb0fe@ipacanada.com
DTSTART:20200121T150000Z
DTEND:20200121T163000Z
DTSTAMP:20191129T140600Z
CREATED:20191129
LAST-MODIFIED:20191205
PRIORITY:5
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TRANSP:OPAQUE
SUMMARY:Change Impact Assessments and Change Plans
DESCRIPTION:This webinar will discuss strategies and processes around doing change impact assessments during change control to ensure appropriate impact is assessed and mitigated.\nWebinar Outline:\n\nImpact assessment as a part of change control\n\nThe ability to assess the impact of a change is integral to the process of change control\nMust be an integral part of your change control procedure\nNot an option\n\n\nWhy do an impact assessment as part of change control?\n\nRegulatory guidance talks to ensuring all changes are reviewed, verified and/or validated as appropriate\nDetermination of “appropriate” is a little vague\nRegulatory guidance does not provide much guidance on how to do an impact assessment\nThe process and procedure must be part of internal SOPs\n\n\nQuick review of the elements of a change description\n\nThe change\nThe reason\nThe justification\n\nThe justification comes from the impact assessment\nYou can’t justify the change without assessing the impact of the change first\n\n\n\n\nLow impact changes\n\nNot all changes require a comprehensive impact assessment\nThere should be a predefined list of changes or change types that do not require a full impact assessment to justify\nThis list of changes or change types should be part of an SOP and fairly short and well defined\n\n\nImpact assessment team\n\nIf it is determined that a full impact assessment is needed a team to do the assessment should be put together\nCan be permanent group or put together as needed\nNeed someone to drive the change\n\nActs as the project manager for the change\n\n\nOther functional areas depending on the nature of the change\n\n\nCreating a change control roadmap\n\nThe use of forms and decision trees is essential to success\nTeam needs to have guidance and a place to record impact decisions\nExamples of decision tree and change impact assessment form\nUnderstanding of risk management impact and regulatory impact is critical\n\n\nConclusions and questions\n\n\nSpeaker:\nAlan Golden, MS, Principal, Design Quality Consultants, LLC\nAlan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations.\nAlan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 10 years.\nAlan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance.\nAlan received his BS degree in Microbiology from the University of Michigan and his MS degree in Molecular Biology and Immunochemistry from the University of Illinois.\n\nWhy you should attend the session:\nChange control is integral to Pharma and Med Device industries to ensure all changes are completely assessed and documented. Proper and complete impact assessments are critical to ensure changes are appropriate and don’t negatively impact other products or processes. This process can be cumbersome if a good strategy and procedures are not implemented.\nWho Will Benefit from this Webinar:\nThis webinar is appropriate for anyone in the Pharmaceutical, Medical Device, or Combination Product Industry.\nThis webinar is for professionals in the Pharmaceutical, Medical Device, or Combination Product industries with responsibilities in the following areas:\n\nQuality Systems\nQuality Assurance\nQuality Control\nChange Control\nEngineering/R&D\nRegulatory Affairs\nValidation\nAuditors\nGMP trainers\nConsultants\n\n\nRegistration Information:\n\nRegister Today!\n\nSingle Registration\nSingle Attendee: $208.00 + HST CAD per session\nSingle attendee refers to single participant at a single computer/login.\nGroup Registration\nGroup of 5 or less per location: $448.00 + HST CAD per session\nGroup of 6 to 10 attendees per location: $788.00 + HST CAD per session\nGroup of 11 to 20 attendees per location: per location: $1288.00 + HST CAD per session\nGroup rates only apply to candidates who wish to have more than one attendee, but will be attending the webinar from a single computer/login. If multiple candidates wish to login at different locations, it will be considered as a separate additional registration and will require more than one webinar login information. Also note that one login information will only be valid on one computer.\n
URL:https://ipacanada.com/events/change-impact-assessments-webinar/
ORGANIZER;CN=IPA Live Webinar:MAILTO:
CATEGORIES:Live Webinar
LOCATION:Online Training
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