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:240402 DTSTAMP:20260409T110718Z SUMMARY:Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs) DESCRIPTION:This webinar will instruct the participant on how to write , organize, and maintain SOPs and train personnel in a way that will e nsure compliance in a way that is concise, reproducible and easy to fo llow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulator y compliance.\nThis will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, impleme nting and maintaining SOPs using a risk based approach and getting SOP s ready for inspection will be presented.Why you should Attend: Stand ard Operating Procedures (SOPs) are required by law for companies that are regulated by the Code of Federal Regulations such as Title 21 and Title 493. Yet there is no guidance on how to write, organize and mai ntain SOPs. Consequently, SOPs are frequently written in a way that ma kes compliance difficult or downright impossible. Worse, this often le ads to many regulatory errors that first come to light during a FDA au dit.Areas Covered in the Session:\n\nSOPs and their relation to the re gulations\nSOPs as part of the company's regulatory infrastructure\nSO P on SOPs and how to ensure conciseness, consistency and ease of use\n Risk Based approach on SOP Best Practices for creation and maintenance \nTraining on SOPs\nTools for SOP tracking and when is validation requ ired\nWhat the FDA looks for in SOPs during an inspection\n\nWho Will Benefit:\n\nCEO\nRegulatory VP\nQuality VP's\nIT VP's\nRegulatory Affa irs Professionals\nQuality Managers\nQuality Engineers\nSmall Business Owners\nGxP\nConsultants\n\n\n\n\nSpeaker ProfileAngela Bazigos is t he CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Health care & Public Health Services.Experience combines Quality Assurance, R egulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospita l, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospi tal. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-au thored Computerized Systems in Clinical Research w/ FDA & DIA Patent o n speeding up software compliance https://www.google.com/patents/US82 66578.Recently quoted in Wall Street Journal for using training to bri ng regulatory compliance to the Boardroom includes training for Societ y of Quality Assurance.Comments / collaborates with FDA on new guidanc e documents. Former President of Pacific Regional Chapter of Society o f Quality Assurance. Stanford's Who's Who for LifeSciences.\n\nEvent l ink:\nhttps://www.compliance4all.com/webinar/--502885LIVE?channel=%20m edtechiq.ning_2020_SEO\n\nContact Info\nNetzealous LLC,DBA -Compliance 4all\nEmail: support@compliance4All.com\nPhone: +1-800-447-9407\nWebsi te: https://www.compliance4all.com/\n\n\nFor more information visit ht tps://medtechiq.ning.com/events/key-factors-to-write-an-effective-stan dard-operating-procedure DTSTART;TZID=America/New_York:20200212T100000 DTEND;TZID=America/New_York:20200212T130000 CATEGORIES:online, event LOCATION:Online WEBSITE:https://www.compliance4all.com/webinar/key-factors-to-write-an -effective-standard-operating-procedure-(sop)-and-work-instructions-(w is)--502885LIVE URL:https://www.compliance4all.com/webinar/key-factors-to-write-an-eff ective-standard-operating-procedure-(sop)-and-work-instructions-(wis)- -502885LIVE CONTACT:+1-800-447-9407 ORGANIZER:Compliance4all ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0 /file/get/2647295700?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle ming":https://medtechiq.ning.com/profile/Compliance4all END:VEVENT END:VCALENDAR