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DTSTAMP:20260414T080427Z
SUMMARY:Webinar On 21 CFR Part 820 - Quality System Regulation - Apply
 ing 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.\nPrior 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.\nAs 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
 .\nUnfortunately, 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.\nIf 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.\n \nIf your design and manufacturing resources are spending t
 oo much time on documentation and not enough time on actual design and
  manufacturing you as a manager need to be looking for ways to simplif
 y their work.\nIn this webinar, we apply the Theory of Lean documents 
 and its corollary Theory of Lean Configuration to present a fresh appr
 oach to following 21 CFR Part 820, yet is based on solid principles an
 d proven practices.\nAreas Covered in the Session :\nBrief introductio
 n to Lean Documents and Lean Configuration\nQuality System Regulation,
  21 CFR Part 820, and ISO 13485 as these apply to design control docum
 ents\nBasic functions found in a life sciences manufacturing plant\nKe
 y types of controlled documents and records for manufacturing\nQuality
  Management System (QMS) elements controlled via documentation\nBringi
 ng it all together\nWho Will Benefit:\nAll Managers, Supervisors, Dire
 ctors, and Vice-Presidents in the areas of:\nResearch & Development\nD
 esign Assurance\nQuality Assurance\nOperations\nDocument Control\nManu
 facturing Engineering\nPrice tags:\nLive\nSingle Live : For One Partic
 ipant\n$ 249\nCorporate Live : For Max. 10 Participants\n$ 899\nRecord
 ing\nSingle REC : For One Participant - Unlimited Access for 6 Months\
 n$ 299\nFor more information and enquiries contact us at\nCompliance T
 rainings\n5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada  Cus
 tomer Support : #416-915-4458  Email : support@compliancetrainings.c
 om\nFor more information about this event please visit\nhttps://compli
 ancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1482\nLike Us
  On Facebook:\nhttps://www.facebook.com/events/455019044651138/\n\nFor
  more information visit https://medtechiq.ning.com/events/webinar-on-2
 1-cfr-part-820-quality-system-regulation-applying-1
DTSTART;TZID=America/New_York:20150416T130000
DTEND;TZID=America/New_York:20150416T143000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=MD1482
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=MD1482
CONTACT:4169154458
ORGANIZER:Compliance Trainings
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562012088?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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