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:62774 DTSTAMP:20260915T150336Z SUMMARY:Webinar On - 21 CFR Part 820 - Quality System Regulation - App lying Principles of Lean Documents and Lean Configuration DESCRIPTION:Description :\nAll life science businesses are required to maintain their Quality Management System (QMS) processes in a state o f control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 2 1 CFR Part 820, have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work ins tructions, SOPs, set-up instructions, equipment maintenance, and suppo rt functions, and that evidence of this work is maintained by controll ed records. Prior to computer systems and databases, managers and qua lity personnel created complex visual numbering schemes, cross-referen cing methods and complex filing systems for purposes of retrieval and control.  These grew over the years into the extremely complex and co nvoluted systems we find today throughout the life sciences, including the medical device industry. As is often the case, automation and co mputers do not always replace the legacy methods, policies, and rules that were necessary with manual and paper systems but are now obsolete . Unfortunately, that is the case in the overwhelming majority of med ical device companies.  The benefits of automation and information re trieval systems are not fully realized due to the legacy policy constr aints that still hamper them. If you are constantly struggling to cre ate, manage, and maintain all of the information found in controlled d ocuments, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will giv e you a different perspective and a very different approach that you c an use. If your design and manufacturing resources are spending too m uch time on documentation and not enough time on actual design and man ufacturing you as a manager need to be looking for ways to simplify th eir work. In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to following 21 CFR Part 820, yet is based on solid principles and pr oven practices.\n \nAreas Covered in the Session :\n\nBrief introduct ion to Lean Documents and Lean Configuration\nQuality System Regulatio n, 21 CFR Part 820, and ISO 13485 as these apply to design control doc uments\nBasic functions found in a life sciences manufacturing plant\n Key types of controlled documents and records for manufacturing\nQuali ty Management System (QMS) elements controlled via documentation\nBrin ging it all together\n\n \nWho Will Benefit:\nAll Managers, Superviso rs, Directors, and Vice-Presidents in the areas of:\n\nR&D\nDesign Ass urance\nQuality Assurance\nOperations\nDocument Control\nManufacturing Engineering\n\n\nAddress:5939 Candlebrook Ct, Mississauga, ON L5V 2V5 , Canada Customer Support : 416-915-4458support@compliancetrainings.co m\nhttps://www.compliancetrainings.com/SiteEngine/ProductDetailView.as px?id=MD1044\n\nFor more information visit https://medtechiq.ning.com/ events/webinar-on-21-cfr-part-820-quality-system-regulation-applying DTSTART;TZID=America/New_York:20140219T120000 DTEND;TZID=America/New_York:20140219T130000 CATEGORIES:online, training LOCATION:Online WEBSITE:https://www.compliancetrainings.com URL:https://www.compliancetrainings.com CONTACT:416-915-4458 ORGANIZER;CN=compliancetrainings:https://medtechiq.ning.com/profile/co mpliancetrainings ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/ file/get/2562011031?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc etrainings:https://medtechiq.ning.com/profile/compliancetrainings END:VEVENT END:VCALENDAR