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DTSTAMP:20260525T140626Z
SUMMARY:Creating Effective SOP for Regulatory Compliance
DESCRIPTION:This FDA documentation webinar will explain the regulatory
  expectations for, and the proper design and maintenance of effective 
 and compliant Standard Operating Procedures (SOPs).\n\n \nWhy Should 
 You Attend:\nThe lack of or inadequate standard operating procedures (
 SOPs) continue to dominate the FDA's inspectional observations. Their 
 frequency lags only behind the Quality Unit concerns. Moreover, SOPs a
 re often used as training tools, which means that they need to be easi
 ly understood by all those whom they affect. Effective SOPs are not on
 ly a regulatory requirement; they also make good business sense. Too m
 any times employees fail to follow SOPs because they can't understand 
 them, and too many times procedures are being constantly revised. This
  leads to lengthy and expensive investigations and costly revisions.\n
 By attending this webinar, you will gain a better understanding the re
 gulatory expectations for, and the proper design and maintenance of ef
 fective and compliant Standard Operating Procedures. You will also lea
 rn how to create and review SOPs, and generate a system for training a
 nd implementation of effective and compliant written procedures.\nArea
 s Covered in the Webinar:\n\nWhy we have written procedures\nWhat FDA 
 expects from our written documentation.\nRegulatory requirements for t
 he creation, compliance and maintenance of written procedures.\nProven
  techniques for creating effective SOPs and other written documents to
  minimize costly revisions.\nAn effective review and approval process 
 compliant with regulatory requirements.\nA system for training and imp
 lementation of written procedures.\nA system for the control, archival
  and disposal of written procedures\n\nWho will Benefit:\n\nQA/ QC\nRe
 gulatory Affairs\nIT/ IS\nTechnical writers\nGeneral staff with the re
 sponsibility for creating, reviewing and approving written standard op
 erating procedures and instructions\n\nInstructor Profile:\nHenry, is
  the founder of GMP TDC LLC, a New York-based training, development an
 d consulting organization serving Life Sciences industries. He has 20+
  years of Life Sciences experience having held positions of increased 
 responsibility in Training, QC Microbiology and QA. His experience inc
 ludes managing GMP compliance and quality systems training, implementi
 ng a training program as part of remediation, and developing an enviro
 nmental monitoring training program. He is a dynamic speaker specializ
 ing in FDA and ICH compliance. He is a Certified Quality Auditor (CQA)
 . His technical education is further complemented by his BA degree in 
 Biology and MBA, which provide a scientific and business insight. He i
 s a member of the ASTD, ASQ, and GMP Training and Education Associatio
 n, GMP TEA.\n\nFor more information visit https://medtechiq.ning.com/e
 vents/creating-effective-sop-for-regulatory-compliance
DTSTART;TZID=America/New_York:20131205T100000
DTEND;TZID=America/New_York:20131205T113000
CATEGORIES:fda, compliance
LOCATION:Online Event
WEBSITE:http://www.complianceonline.com/ecommerce/control/trainingFocu
 s/~product_id=702999?channel=
URL:http://www.complianceonline.com/ecommerce/control/trainingFocus/~p
 roduct_id=702999?channel=
CONTACT:+1-650-620-3915
ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer
 ral512
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
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ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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