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DTSTART:19700308T020000
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UID:2140535:Event:67509
DTSTAMP:20260521T141715Z
SUMMARY:Webinar On Quality by Design (QbD) for Development and Validat
 ion of Analytical Methods
DESCRIPTION:Description :\nUsing the QbD approach for development and 
 validation will result in more robust analytical methods. Advantages a
 re easier method transfer, longer revalidation cycles and fewer or no 
 methods specific Out-of-Specification situations when used in routine.
  In addition, FDA, USP and international agencies promote the QbD appr
 oach because it is expected that such performance based routine method
 s can be changed within the analytical target profile (ATP) without re
 gulatory resubmission and approval. Moreover, the new FDA Method Valid
 ation Guide suggests using QbD elements for development and validation
 . Because there is no or little experience with the QbD approach for a
 nalytical methods, the industry has many questions. For easy implement
 ation, attendees will receive: Master plan - Template and examples: De
 velopment and Validation of Analytical Methods through QbD SOP - Devel
 opment and Validation of Analytical Methods through Quality by Design 
 Checklist - Validation of Analytical Methods according to the FDA Guid
 ance 2015 Areas Covered in the Session : General principles and key be
 nefits of QbD Regulatory background and trends: FDA, ICH Q8/9/10 Reaso
 ns for changing the way we validate methods Current applications of Qb
 D in the pharmaceutical industry The Application of QbD for analytical
  methods Comparison of the QbD process with ICH Q2 and USP <1225> Bene
 fits for method transfer and routine use Using the lifecycle approach 
 for method design, development and validation Developing specification
 s and, the analytical target profile Documenting input variables for r
 isk assessment in fishbone diagrams Using the risk assessment prioriti
 zation matrix to select the test parameters Traditional vs. the QbD pr
 ocess for method parameter optimization The method validation and qual
 ification studies Using the method in the routine: on-going performanc
 e control, review and change control Continuous monitoring and improve
 ments Documentation requirements Defining the Analytical Target Profil
 e (ATP) and design space Case studies Who Will Benefit: A must attend 
 webinar for professionals in Pharmaceutical and medical device industr
 y, Manufacturers of drug substances (APIs) and Contract laboratories, 
 Contract manufacturing organizations, Clinical research organizations.
  The teams that will benefit the most are: QA Managers and Personnel A
 nalysts and Lab Managers Regulatory Affairs Training Departments Metho
 d Development Departments Documentation Departments Consultants \n\nFo
 r more information visit https://medtechiq.ning.com/events/webinar-on-
 quality-by-design-qbd-for-development-and-validation
DTSTART;TZID=America/New_York:20151209T130000
DTEND;TZID=America/New_York:20151209T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=FDB1761
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=FDB1761
CONTACT:4169154458
ORGANIZER:Compliance Trainings
ATTACH;FMTTYPE="image/jpeg":
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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