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:63197
DTSTAMP:20260507T135823Z
SUMMARY:Establish Change Control for Pharmaceutical Stability Program
DESCRIPTION:This webinar on pharmaceutical stability program will disc
 uss the types of CMC changes in the life cycle of a pharmaceutical pro
 duct and how it affects the stability program.\n\nWhy Should You Atten
 d:\nNew medicines are developed every day to meet medical needs and im
 prove quality of life. Stability program is necessary for product regi
 stration, and changes to the product require additional stability stud
 ies. As part of GMP requirements, pharmaceutical companies must establ
 ish a change control system to monitor any change to the product, proc
 ess or package.\nThis session will discuss what type of changes exist 
 in the product life cycle and how these changes can affect the stabili
 ty profile of the pharmaceutical product through expiry. The instructo
 r will also discuss potential risks to manage these changes to the sta
 bility program.\nLearning Objectives:\nUpon completion of this session
 , attendees will understand the factors that would affect the stabilit
 y program and how to establish the change control to support product m
 arketing strategies. This session will also discuss the observations a
 nd infractions due to lack of change control system of the program.\nA
 reas Covered in the Webinar:\n\nStability is defined as a critical qua
 lity attribute\nWhat type of CMC changes in the life cycle of a drug p
 roduct\nHow changes affect the stability profile of the product throug
 hout the expiry\nDistinguish between minor and major changes of a regi
 stration stability program\nDetermine potential risks to manage these 
 stability changes\n\nWho will benefit:\n\nQuality Control managers and
  personnel\nPharmaceutical scientists\nManufacturers of raw material a
 nd ingredients\nAnalysts and lab managers\nQA managers and personnel\n
 Regulatory affairs\nCompliance scientists\n\nInstructor Profile:\nKim 
 Huynh-Ba, has almost 25 years of experience in analytical development
 , project management, strategic drug development and stability science
 s. She currently is the Executive Director of Pharmalytik, where she p
 rovides consulting and training services to pharmaceutical companies, 
 including companies operating under FDA’s Consent Decree on harmoniz
 ation and optimization of analytical best practices since 2003. Her cl
 ients are from various sizes of pharmaceutical companies in US and abr
 oad. Prior to Pharmalytik, she was the Director of Pharmacopeial Educa
 tion Department of U.S. Pharmacopeia (USP), where she was responsible 
 for their education programs worldwide. Kim has held several technical
  and quality positions at Astra Zeneca (formerly ICI Americas), DuPont
  Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccine
 s. Kim is also a short course instructor on cGMP compliance and qualit
 y topics for several global organizations such as American Chemical So
 ciety (ACS), American Association of Pharmaceutical Scientists (AAPS),
  Pittsburgh Conference, and many other international training groups. 
 She is an Adjunct Professor at Temple University-School of Pharmacy, W
 idener University and Illinois Institute of Technology (IIT) teaching 
 pharmaceutical analysis and analytical chemistry graduate courses.\n\n
 For more information visit https://medtechiq.ning.com/events/establish
 -change-control-for-pharmaceutical-stability-program
DTSTART;TZID=America/New_York:20140306T100000
DTEND;TZID=America/New_York:20140306T113000
CATEGORIES:pharmaceutical
LOCATION:Online Event
WEBSITE:http://www.complianceonline.com/ecommerce/control/trainingFocu
 s/~product_id=702968?channel=medtechiq
URL:http://www.complianceonline.com/ecommerce/control/trainingFocus/~p
 roduct_id=702968?channel=medtechiq
CONTACT:+1-650-620-3915
ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer
 ral512
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562006613?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
END:VEVENT
END:VCALENDAR