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:62316 DTSTAMP:20260416T130607Z SUMMARY:2-day In-person Seminar on “Writing and Enforcing Effective SOPs” at Minneapolis DESCRIPTION:Overview:\nWriting SOPs or procedural documents can be cha llenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented i n the pipeline is another story. The term SOP is very obvious. We have seen \"clearly written description of how specific tasks are to be do ne.\" Another satisfactory definition would be \"detailed written inst ructions that achieve the uniformity of the performance of a specific function.\" Is the firm doing what the regulations specify? Is the fir m doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise bec ause when it comes to FDA regulations and guidance documents \"establi sh\" means to define, to document (in writing or electronically) and t o implement. The goal and emphasis with FDA is simple. Proof of \"Esta blish\" is the foundation. Is the firm doing what the regulations spec ify? Is the firm doing what their procedures specify? Are the procedur es being followed and enforced by company personnel? SOPs are needed i n regulated industries to give step-by-step instructions for performin g a particular job or task. This session will provide a step-by-step o verview and a snapshot of the procedure description, the process and f ormat. The subject matter of a SOP may range from how to operate a pie ce of machinery to how to log into a particular software program. SOPs ensure consistency and reliability because they require training of a ll affected parties.  This session will address recent enforcement a ctions for SOP related violations but no surprise. Most of our enforce ment actions are documentation related, i.e., SOP or other procedural documents. \nWho Will Benefit:\n\nRegulatory Affairs\nClinical Affair s\nQuality Assurance/Quality Control\nCompliance\nMarketing & Sales\nM anufacturing and Technical Services\nEngineering\nIT/MIS\nExecutive Ma nagement\nLaboratory Operations\nCustomer Service\nClinical Research m anagers and personnel\nSpecialists/SMEs in all departments\nQA/RA mana gers and personnel\nQuality System auditors\nDistributors/Authorized R epresentatives\nLegal Counsel\nConsultants\n\nSpeaker Profile:\nDavid R. Dills, Regulatory Affairs & Compliance Consultant currently provide s regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of experience with Class I /II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems. He ha s been previously employed, with increasing responsibilities by medica l device manufacturers and consultancies, including a globally recogni zed CRO.\nDATE, VENUE & PRICE:\nLocation: Minneapolis, MN| Sep 26th & 27th, 2013 | 9 AM to 6 PM PDT Venue: WILL BE ANNOUNCED SOON\nPrice: $1295.00\n \nContact Information: Event Coordinator\nToll free: 180 0 447 9407\nFax: 302 288 6884\nEmail: support@globalcompliancepanel.co m\nWebsite: https://www.globalcompliancepanel.com\nLIVE CHAT SUPPORT A LSO - http://www.globalcompliancepanel.com/chat/client.php\nGlobalComp liancePanel\nNetZealous LLC\n161 Mission Falls Lane, Suite 216, Fremon t, CA 94539, USA\nFor More Details: http://bit.ly/14G2c2H\n\nFor more information visit https://medtechiq.ning.com/events/http-bit-ly-14g2c2 h DTSTART;TZID=America/New_York:20130926T090000 DTEND;TZID=America/New_York:20130927T180000 CATEGORIES:conference LOCATION:United States WEBSITE:http://bit.ly/14G2c2H URL:http://bit.ly/14G2c2H CONTACT:8004479407 ORGANIZER;CN="John Robinson":https://medtechiq.ning.com/profile/JohnRo binson ATTACH;FMTTYPE="image/jpeg": ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob inson":https://medtechiq.ning.com/profile/JohnRobinson END:VEVENT END:VCALENDAR