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DTSTART:19700308T020000
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UID:2140535:Event:66702
DTSTAMP:20260415T232203Z
SUMMARY:Webinar On Current Regulatory Requirements for Aseptically Pro
 duced Products
DESCRIPTION:Description :\nThe manufacture of sterile products, whethe
 r by aseptic means or terminal sterilization, requires a thorough unde
 rstanding of applicable regulations by the FDA and those by the EU if 
 selling your products overseas. In addition, there are various guidanc
 e documents that address other issues such as closure integrity and st
 erility test methods that were recently revised in 2012.\nToday, the r
 egulatory requirements for sterile products are found in a “Guidance
  for Industry” document that was published in 2004. In addition, the
 re are requirements found in 21 CFR 210-211 and 820. In all of these d
 ocuments, the areas of importance and audit focus are;\nEquipment, uti
 lity and facility qualifications\nValidation of all sterilization proc
 esses\nControl of the environment and potential sources of contaminati
 on\nPersonnel training and gowning requirements based on defined areas
  of cleanliness\nLaboratory controls and\nProcess simulations designed
  to verify the acceptability of the manufacturing process and operator
  activities.\nThis webinar will discuss the most important issues that
  apply to sterile products in order to provide an overview for attende
 es to evaluate their own processes and procedures. It will not go into
  detail on the various sterilization methods that are used within the 
 industry, nor will it detail how best to establish process simulations
 . Recent 483 observations will be reviewed to help highlight common in
 dustry deficiencies and as a reference to compare attendees current pr
 actices.\nAreas Covered in the Session :\nReview the current regulator
 y requirements and guidance documents dealing with sterile products\nR
 eview the expectations for aseptically produced products.\nDiscuss the
  six quality systems that are reviewed during regulatory inspections\n
 Review common deficiencies cited with the manufacture of sterile drugs
 \nReview the importance of personnel training and control of microbiol
 ogical contamination\nWho Will Benefit:\nDrug manufacturers\nContract 
 manufacturing companies\nSterile product vendors\nQuality assurance\nQ
 uality control\nManufacturing\nValidation\nProduction\nRegulatory comp
 liance\n\nFor more information visit https://medtechiq.ning.com/events
 /webinar-on-current-regulatory-requirements-for-aseptically
DTSTART;TZID=America/New_York:20150817T130000
DTEND;TZID=America/New_York:20150817T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=FDB1661
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=FDB1661
CONTACT:4169154458
ORGANIZER:Compliance Trainings
ATTACH;FMTTYPE="image/jpeg":
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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