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:79352
DTSTAMP:20260522T010614Z
SUMMARY:Webinar On \"Assess Your Laboratory - Based on the FDA System 
 Based Inspections\"
DESCRIPTION:Description :\nThe Quality Control Laboratory plays an imp
 ortant part role in the production and release of a drug product regul
 ated by the FDA. Inspectional observations of non-compliant laboratory
  operations are high on the list of most frequent regulatory observati
 ons. As the industry focuses more on the quality system and product an
 d test method lifecycle, the operation of the laboratory unit becomes 
 more visible. The laboratory should have active programs in which the 
 laboratory is routinely assessed for compliance to applicable regulati
 ons and standards.\nAreas Covered in the Session :\nStandards for the 
 assessment of laboratories FDA System based inspection The audit proce
 ss – what to look for The audit report Audit follow-up\nWho Will Ben
 efit:\nMethod Development laboratory managers Quality Control laborato
 ry managers Quality Assurance Managers Analytical Method Development c
 hemists Quality Control chemists Internal auditors\nAbout Speaker:\nJo
 hn G. (Jerry) Lanese is an independent consultant with a focus on Qual
 ity Systems and the components of an effective Quality System. He rece
 ived a BA and MS from Middlebury College and a Ph.D. in Analytical Che
 mistry from the University of Michigan and began his career teaching A
 nalytical Chemistry in a small liberal arts college. Dr. Lanese moved 
 from the academic environment to the pharmaceutical industry where he 
 has managed Analytical Research, Quality Control and Quality Assurance
  functions.\nIn 1994 Dr. Lanese formed his own company, The Lanese Gro
 up, and since that time he has been a consultant in the area of qualit
 y system and cGMP compliance and has audited and consulted with small 
 and large medical device and pharmaceutical companies, including compa
 nies under FDA Consent Decree, API and excipient manufacturers, electr
 onic firms and other manufacturing organizations.\nDr. Lanese focuses 
 on training. He lectures throughout the world and presents training in
  all formats (lectures, seminars and webinars) on a variety of topics 
 related to Quality Systems, GMPs, APIs, training, laboratory operation
 s, calibration, change control, deviations and product reviews for cli
 ents and seminar, webinar and conference providers. Jerry is a member 
 of the Editorial Board of the Journal of GXP Compliance.\n\nFor more i
 nformation visit https://medtechiq.ning.com/events/webinar-on-assess-y
 our-laboratory-based-on-the-fda-system-based
DTSTART;TZID=America/New_York:20180626T130000
DTEND;TZID=America/New_York:20180626T143000
CATEGORIES:online, "/", webinar
LOCATION:Online
WEBSITE:http://www.compliancetrainingpanel.com/Webinar/Topic?WB=MP0010
 1
URL:http://www.compliancetrainingpanel.com/Webinar/Topic?WB=MP00101
CONTACT:1-844-216-5230
ORGANIZER;CN="Sam Miller":https://medtechiq.ning.com/profile/SamMiller
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562016632?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Sam Mill
 er":https://medtechiq.ning.com/profile/SamMiller
END:VEVENT
END:VCALENDAR