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:66850
DTSTAMP:20260522T115857Z
SUMMARY:Webinar on Developing an Effective CAPA Program for GMP Operat
 ions
DESCRIPTION:Overview: Having an effective CAPA documentation and trac
 king system are crucial to pharmaceutical operations. This system will
  allow personnel to identifying the root cause, corrective action take
 n, and verification stages. This session will discuss important compon
 ents to create an effective CAPA system, determine different levels of
  actions to be taken, and training needed to prevent reoccurrence.\nWh
 y should you attend: \nFDA and regulatory agencies are looking closel
 y in how pharmaceutical companies conduct their investigations, and CA
 PA is viewed as the central component of Quality Management Systems. H
 owever, a significant number of FDA_483 observations and Warning Lette
 rs cite CAPA deficiencies. This session will cover regulatory requirem
 ent for a CAPA system.Areas Covered in the Session:\n\nWhy an effectiv
 e CAPA system is important\nRoles and responsibilities of manufacturer
 s\nIdentifying sources of infractions\nDetermining root causes\nCAPA T
 racking System and documentation\n\nWho Will Benefit:\n\nLaboratory An
 alysts\nQuality Assurance scientists\nQA/QC Analysts\nQA/QC Managers\n
 Auditors\nInspectors\nPharmaceutical development and manufacturing per
 sonnel\nManufacturers of raw materials and excipients\nContract labora
 tory Organization personnel\n\nSpeaker Profile:\n\nKim Huynh-Ba has a
 lmost 25 years of experience in analytical development, project manage
 ment, strategic drug development and stability sciences. She currently
  is the Executive Director of Pharmalytik, where she provides consulti
 ng and training services to pharmaceutical companies, including compan
 ies operating under FDA’s Consent Decree on harmonization and optimi
 zation of analytical best practices since 2003. Her clients are from v
 arious sizes of pharmaceutical companies in US and abroad. Prior to Ph
 armalytik, she was the Director of Pharmacopeial Education Department 
 of U.S. Pharmacopeia (USP), where she was responsible for their educat
 ion programs worldwide. Kim has held several technical and quality pos
 itions at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont P
 harmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. \nContact De
 tail:\nNetZealous - Compliance4All,161 Mission Falls Lane, Suite 216, 
 Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: support@complian
 ce4All.comhttp://www.compliance4all.com/Event Link : http://bit.ly/1P
 OPHYi\n\n\n\nFor more information visit https://medtechiq.ning.com/eve
 nts/webinar-on-developing-an-effective-capa-program-for-gmp
DTSTART;TZID=America/New_York:20151012T100000
DTEND;TZID=America/New_York:20151012T110000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:http://bit.ly/1POPHYi
URL:http://bit.ly/1POPHYi
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