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:66866
DTSTAMP:20260520T092952Z
SUMMARY:Webinar on 21st Century Validation
DESCRIPTION:Overview: The 'why' and 'what' and the events / backgroun
 d that have impacted validation over the last 25 years will be present
 ed.\nThe importance of an organization's Quality System for validation
  will be put into perspective to help attendees identify potential gap
 s in their validation programs. The presentation will discuss the impo
 rtance of 'focusing on critical aspects' and having meaningful, well-w
 ritten User Requirements Specifications as key elements on establishin
 g a streamlined and simplified validation program for capital projects
 . Why should you Attend: \nToday's pharmaceutical manufacturing comp
 any's compliance with global regulatory expectations should not be a d
 ifficult task - but many companies are still finding it to be a challe
 nge to get it right. FDA and EU regulatory expectations have evolved o
 ver the last 20 years and a new 'improved' validation approach is emer
 ging that offers validation and engineering organizations the possibil
 ity of streamlining and simplifying validation activities. This appro
 ach will help organizations control costs associated with building and
  starting new facilities and engineered systems. This may ultimately e
 nable today's limited number of an organization's technical resources 
 to spend their time and energy working on gaining better process knowl
 edge as needed to optimize process capability. Areas Covered in the S
 ession:\n\n25 Years of Validation\nCommissioning and Qualification (De
 -mystified)\nGlobal Harmonization\nEU vs US GMP (Regulatory Expectatio
 ns)\nThe Importance of ASTM E2500\nKISS Examples: Keep It Streamlined 
 and Simple\nReasons for Poor Validation Programs\nQ & A\n\nWho Will Be
 nefit:\n\nManagers / Directors of Validation\nManagers / Directors of 
 Engineering\nManagers / Directors of Quality Assurance\nSr. Validation
  Engineers and Project Managers\nRegulatory Compliance Professionals\n
 \nSpeaker Profile:\n\nSam DeMarco is a Sr. Compliance Consultant and 
 president of Compliance Team, Inc. Sam has over 25 years of technical,
  managerial, and consultative experience in the pharmaceutical and med
 ical device industries. He earned his MBA from Loyola University of Ch
 icago and BS in Mechanical Engineering from the University of Illinois
 . In 2009, he earned the International Society of Engineer’s certifi
 ed pharmaceutical industry professional (CPIP) credential. His subject
  matter expertise covers a broad area of knowledge, which includes eng
 ineering, commissioning, validation, project management, quality assur
 ance, and pharmaceutical manufacturing and product quality compliance.
  Sam’s comprehensive knowledge of and experience with implementing t
 echnical requirements for a diverse portfolio of projects has helped h
 im to be an accomplished expert on developing robust quality system po
 licies and procedures. His leadership has contributed too many success
 ful launches of new manufacturing facilities, process technologies, an
 d products in compliance with regulatory requirements and expectations
 .\nContact Detail:\nNetZealous - Compliance4All,161 Mission Falls Lane
 , Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: sup
 port@compliance4All.comhttp://www.compliance4all.com/Event Link : htt
 p://bit.ly/1NG6j5b\n\n\n\nFor more information visit https://medtechiq
 .ning.com/events/webinar-on-21st-century-validation
DTSTART;TZID=America/New_York:20151030T100000
DTEND;TZID=America/New_York:20151030T110000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:http://bit.ly/1NG6j5b
URL:http://bit.ly/1NG6j5b
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