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:66783
DTSTAMP:20260525T033123Z
SUMMARY:Webinar on Lyophilization Technology
DESCRIPTION:Overview: Lyophilization cycles consist of three phases: 
 Freezing, primary drying, and secondary drying. Conditions in the drye
 r are varied through the cycle to ensure that the resulting product ha
 s the desired physical and chemical properties and that the required s
 tability and sterility is achieved and maintained.\nDuring the freezin
 g phase, the goal is to freeze the mobile water of the product. Signif
 icant supercooling may be encountered, so the product temperature may 
 have to be much lower that the actual freezing point of the solution b
 efore freezing occurs. Generating very large frozen particles due to t
 he initial freezing process can cause the sedimentation rate to go way
  up causing a much longer cycle than effective design of the process c
 an accomplish making the process more cost effective and higher qualit
 y. Why should you Attend: \nThe fundamental principles and technolog
 y are coupled with practical aspects of lyophilization in the training
  program. Principles and concepts presented are later used to discuss 
 real world pracdtical applications. The long term training sessions in
 clude participants in development, operations, engineering, technical 
 services, quality, validation, and regulatory affairs. Brief on-line t
 raining addresses critical aspects of freeze drying to ensure complian
 ce, validation and minimization of patient risk based on the developme
 nt of the product proven to have been during the clinical trials befor
 e the product was transferred into commercial scale operations. Areas
  Covered in the Session:\n\nEssentially a brief discussion about each 
 of the Critical Aspects and related affects of Variables\nLyophilizati
 on 101 – Comprehension on each step of the Freeze Drying/Lyophilizat
 ion Process\nUnderstanding why various steps of the process become mor
 e advantageous and cost effective\nSublimation Rate Variability\nHeat 
 Transfer\nLoss of Protein Activity\nFreezing Affects on Primary Drying
 \nOptimization of Primary Drying and Proof of the effectiveness of Sec
 ondary Drying\nEffects of Freezing Method and Excipients on Protein Su
 rface\nInfluence of Packing Density and the container selection\nResid
 ual Moisture Regulatory Considerations by the FDA\n\nWho Will Benefit:
 \n\nCompliance Manager\nProcess Engineer\nValidation Manager\nRegulato
 ry Manager\n\n\n\nSpeaker Profile:Jerry Dalfors has extensive (40 yea
 rs) of business administration, consultative, technical and managerial
  experience in the development and manufacture of highly regulated bio
 pharmaceutical products including injectables, biologics, medical devi
 ces and oral dosages. He has held permanent employee, temporary emplo
 yee and company representative management positions with a multitude o
 f the major pharmaceutical and biotechnology companies in the US. He h
 as worked with or assisted more than two dozen companies with the esta
 blishment of controlled document/quality systems, FDA briefing and sub
 mittal documents, project management of several multimillion dollar pr
 ojects including design, start-up and validation to assure fast track 
 FDA approval by maintaining strict regulatory compliance.\nContact Det
 ail:\nNetZealous - Compliance4All,161 Mission Falls Lane, Suite 216, F
 remont, CA 94539, USA. Phone: +1-800-447-9407 Email: support@complianc
 e4All.comhttp://www.compliance4all.com/Event Link : http://bit.ly/1Rc
 UuDp\n\n\n\nFor more information visit https://medtechiq.ning.com/even
 ts/webinar-on-lyophilization-technology
DTSTART;TZID=America/New_York:20151110T100000
DTEND;TZID=America/New_York:20151110T110000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:http://bit.ly/1RcUuDp
URL:http://bit.ly/1RcUuDp
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/2562012364?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
END:VEVENT
END:VCALENDAR