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DTSTART:19700308T020000
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UID:2140535:Event:68993
DTSTAMP:20260601T014012Z
SUMMARY:Webinar on Key Factors to Write an Effective Standard Operatin
 g Procedure
DESCRIPTION:Overview: \nThis webinar will instruct the participant on
  how to write, organize, and maintain SOPs and train personnel in a wa
 y that will ensure compliance in a way that is concise, reproducible a
 nd easy to follow.\nIt will begin with a strategic view of SOPs in a c
 ompany and how SOPs can help streamline operations in addition to ensu
 ring regulatory compliance. This will be followed by explanation on ho
 w to get from regulations to the SOP. Finally, Best Practices for crea
 ting, implementing and maintaining SOPs using a risk based approach an
 d getting SOPs ready for inspection will be presented.Why you should a
 ttend:\nStandard Operating Procedures (SOPs) are required by law for c
 ompanies 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, org
 anize and maintain SOPs. Consequently, SOPs are frequently written in 
 a way that makes compliance difficult or downright impossible. Worse, 
 this often leads to many regulatory errors that first come to light du
 ring an FDA audit. \nAreas Covered In the Session:\n\nSOPs and their 
 relation to the regulations\nSOPs as part of the company's regulatory 
 infrastructure\nSOP on SOPs and how to ensure conciseness, consistency
  and ease of use\nRisk Based approach on SOP Best Practices for creati
 on and maintenance\nTraining on SOPs\nTools for SOP tracking and when 
 is validation required\nWhat the FDA looks for in SOPs during an inspe
 ction\n\nWho will benefit:\n\nAnyone that creates / maintains SOPs\nVP
 , Director, Manager of any dept that writes SOPs or performs training\
 nQA / QC\nRegulatory Affairs\n\nSpeaker Profile: \nAngela Bazigos ,
  is the Chief Compliance Officer of Morf Media. She has 40 years of ex
 perience in the Lifesciences industry spanning GLP, GCP, GMP, Medical 
 Devices & 21 CFR 11 and has a patent aimed at speeding up Software Com
 pliance. Ms. Bazigos is a Past President of PRCSQA, a member of the S
 QA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf o
 f her clients. She consults to LifeScience Investment Groups as well a
 s to Pharma / Biotech / Medical Device companies on compliance matters
 , including strategy, submissions, quality assurance and remediations 
 following action by the FDA. \n\nContact Detail:\nCompliance4All DBA 
 NetZealous,Phone: +1-800-447-9407Email: support@compliance4All.comhttp
 ://www.compliance4all.com/Event Link : http://bit.ly/Standard_Operati
 ng_Procedure\nLinkedIn Follow usTwitter Follow usFacebook Like us\n\n\
 nFor more information visit https://medtechiq.ning.com/events/webinar-
 on-key-factors-to-write-an-effective-standard-operating-1
DTSTART;TZID=America/New_York:20160512T100000
DTEND;TZID=America/New_York:20160512T113000
CATEGORIES:webinar
LOCATION:Online Event
WEBSITE:http://bit.ly/Standard_Operating_Procedure
URL:http://bit.ly/Standard_Operating_Procedure
CONTACT:18004479407
ORGANIZER;CN="Adam Fleming":https://medtechiq.ning.com/profile/Complia
 nce4all
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562012284?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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