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DTSTAMP:20260603T004516Z
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).\nWhy Should You At
 tend:\nThe lack of or inadequate standard operating procedures (SOPs) 
 continue to dominate the FDA's inspectional observations. Their freque
 ncy lags only behind the Quality Unit concerns. Moreover, SOPs are oft
 en used as training tools, which means that they need to be easily und
 erstood by all those whom they affect. Effective SOPs are not only a r
 egulatory requirement; they also make good business sense. Too many ti
 mes 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.\nBy att
 ending this webinar, you will gain a better understanding the regulato
 ry expectations for, and the proper design and maintenance of effectiv
 e and compliant Standard Operating Procedures. You will also learn how
  to create and review SOPs, and generate a system for training and imp
 lementation of effective and compliant written procedures.\nAreas Cove
 red in the Webinar:\n\nWhy we have written procedures\nWhat FDA expect
 s from our written documentation.\nRegulatory requirements for the cre
 ation, compliance and maintenance of written procedures.\nProven techn
 iques for creating effective SOPs and other written documents to minim
 ize costly revisions.\nAn effective review and approval process compli
 ant with regulatory requirements.\nA system for training and implement
 ation of written procedures.\nA system for the control, archival and d
 isposal of written procedures\n\nWho will Benefit:\n\nQA/ QC\nRegulato
 ry Affairs\nIT/ IS\nTechnical writers\nGeneral staff with the responsi
 bility for creating, reviewing and approving written standard operatin
 g procedures and instructions\n\nInstructor Profile:\nHenry, is the f
 ounder of GMP TDC LLC, a New York-based training, development and cons
 ulting organization serving Life Sciences industries. He has 20+ years
  of Life Sciences experience having held positions of increased respon
 sibility in Training, QC Microbiology and QA. His experience includes 
 managing GMP compliance and quality systems training, implementing a t
 raining program as part of remediation, and developing an environmenta
 l monitoring training program. He is a dynamic speaker specializing in
  FDA and ICH compliance. He is a Certified Quality Auditor (CQA). His 
 technical education is further complemented by his BA degree in Biolog
 y and MBA, which provide a scientific and business insight. He is a me
 mber of the ASTD, ASQ, and GMP Training and Education Association, GMP
  TEA.\n\nFor more information visit https://medtechiq.ning.com/events/
 creating-effective-sop-for-regulatory-compliance-1
DTSTART;TZID=America/New_York:20131218T100000
DTEND;TZID=America/New_York:20131218T113000
CATEGORIES:food, healthcare
LOCATION:Online Event
WEBSITE:http://www.complianceonline.com/ecommerce/control/trainingFocu
 s/~product_id=702999?channe=medtechiq
URL:http://www.complianceonline.com/ecommerce/control/trainingFocus/~p
 roduct_id=702999?channe=medtechiq
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/
 file/get/2562006613?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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