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DTSTART:19700308T020000
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DTSTAMP:20260522T105812Z
SUMMARY:Webinar On - ICH Q10 Pharmaceutical Quality System
DESCRIPTION:Description :\nICH Q10 is particularly important because t
 he USA, Canada, Europe, and Japan have announced their intentions to a
 dopt the ICH Q10 guidance. Therefore, it is necessary to understand an
 d comply with this guidance in order to market your products across in
 ternational boundaries. However, there is another and probably more im
 portant reason.  The reason being that this guidance has some very us
 eful quality concepts that have the potential to help maintain and imp
 rove your quality system for improving compliance and increasing custo
 mer satisfaction. For greater insight about maintaining and improving 
 quality systems, review the FDA's “Quality Systems Approach to the P
 harmaceutical GMPs”  This webinar provides a broad overview of ICH Q
 10, The Pharmaceutical Quality System. ICH Q10 is applicable throughou
 t the pharmaceutical lifecycle. Unlike the FDA Quality Systems Approac
 h limited applicability, ICH Q10 explains the application of quality p
 rinciples and concepts to the regulations. The ICH Q10 concepts will b
 e presented in a logical sequence that will show their applicability t
 o the pharmaceutical product lifecycle to strengthen the link between 
 pharmaceutical development and manufacturing activities.  This webinar
  focusses on The Quality Systems Approach (QSA) To Pharmaceutical Good
  Manufacturing Practices. The focal point of the QSA is drug substance
 s and products but its principles apply to all FDA regulated industry.
  This guidance is written in a non-regulatory format explaining GMP co
 ncepts in a practical and easily understood way. This webinar uses man
 y graphical aids to increase interest and enhance training.  Middle an
 d Senior Management from all functions involved in establishing and ex
 ecuting corporate strategy and objectives. It is particularly applicab
 le to companies new to the FDA regulated industry.  Senior quality man
 agement will gain insight on how quality systems work and will be able
  to better understand senior management responsibilities. Provide know
 ledge that can be used to persuade others concerning quality matters. 
  Finance, Sales and Marketing, Operations, Procurement, and Human Reso
 urces who have an active or supporting role in Quality.  Other quality
  personnel who have the desire and/or potential to advance to quality 
 leadership.\n \nAreas Covered in the Session :\n\nCourse Introduction
 , Objectives, & Quality Philosophy\nDefining the Role of Quality and C
 ompliance in the Organization\nWhy does ICH Q10-10, Pharmaceutical Qua
 lity Systems, Exist? Introduction, Scope & Objectives\nArrangement & O
 rganization of the ICHQ 10 Guidance\nRelationship to other regulatory 
 requirements & regional regulations\nEnablers-Knowledge, Risk, & Desig
 n Management\nIntroduction to the Pharmaceutical Product Lifecycle\nFi
 rst Introduction to the Quality Manual\nManagement Responsibility\nPha
 rmaceutical Quality System Elements\nContinual Improvement of Process 
 Performance & Product Quality\nContinual Improvement of the Pharmaceut
 ical Quality System\nRegulatory Body Enforcement\nQuick Review\nQ&A\n\
 n5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada Customer Support
  : 416-915-4458support@compliancetrainings.comhttps://www.compliancetr
 ainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1061\n \n\nFor mo
 re information visit https://medtechiq.ning.com/events/webinar-on-ich-
 q10-pharmaceutical-quality-system
DTSTART;TZID=America/New_York:20140205T120000
DTEND;TZID=America/New_York:20140205T130000
CATEGORIES:online, training
LOCATION:Online
WEBSITE:https://www.compliancetrainings.com
URL:https://www.compliancetrainings.com
CONTACT:416-915-4458
ORGANIZER;CN=compliancetrainings:https://medtechiq.ning.com/profile/co
 mpliancetrainings
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562011031?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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