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DTSTART:19700308T020000
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UID:2140535:Event:63800
DTSTAMP:20260520T142317Z
SUMMARY:Quality Management Systems - Creating, Implementing and Improv
 ing
DESCRIPTION:Overview:\nToday's manufacturers face enormous challenges 
 managing their quality and compliance initiatives. Market trends point
  to even greater scrutiny of these efforts as pressure mounts from bot
 h consumers and regulatory agencies for manufacturers across a broad r
 ange of industries to deliver better, safer products and services. To 
 meet these important regulatory challenges, it is imperative that manu
 facturers have a quality management system to manage processes and pro
 vide timely access to relevant data, effectively and efficiently. Qua
 lity systems, time and again, have been responsible for substantial in
 creases in the bottom line of businesses in every industry and have gi
 ven organizations the boost they need to meet overall goals and object
 ives. The principle of a Quality Management System is introduced in Ch
 apter 1 of EU GMPs (Vol 4) as follows: The holder of a Manufacturing A
 uthorisation must manufacture medicinal products so as to ensure that 
 they are fit for their intended use, comply with the requirements of t
 he Marketing Authorisation or Clinical Trial Authorisation, as appropr
 iate and do not place patients at risk due to inadequate safety, quali
 ty or efficacy. The attainment of this quality objective is the respon
 sibility of senior management and requires the participation and commi
 tment by staff in many different departments and at all levels within 
 the company, by the company's suppliers and by its distributors. Why 
 should you Attend: QMS is a large, complex system that reaches all pa
 rts of the organization. It applies across the whole product lifecycle
  - covering more activities than just those in scope for GMPs. It is a
  daunting task to be asked to lead such an implementation. It can beco
 me a most fulfilling task, provided you know who to get on your side a
 nd where to look for assistance. Areas Covered in the Session:\n\nBri
 ef History of QMS / ISO 9000\nICH Q10 and Topic Headings\nACM Cultural
  Survey for QMS readiness\nQuality Policy, Vision and Values\nSponsors
 hip\nBuilding the Business Case\nCreation methodology\nCreation option
 s for small and large companies\nImplementation Process - Plan, Organi
 se, Communicate, Measure, Review, Improve\nMore Change Management for 
 Implementation / Rewards\nLaunch readiness check\nInspection Managemen
 t\nGap Analysis to monitor compliance\nImprovement Techniques\nInterna
 l Audits, CAPA, Management Review\nBehavioral Programs\nKeeping Curren
 t / Software options\n\nWho Will Benefit:\n\nManaging Director\nGenera
 l Manager\nSite Director\nQuality Assurance VP / Director / Manager\nV
 P Manufacturing Operations\nResponsible Person (wholesaler dealer)\nQu
 alified Person\n\nQuick Contact:\nGlobalCompliancePanel USA Phone:800-
 447-9407Fax: 302-288-6884webinars@globalcompliancepanel.comhttp://www.
 globalcompliancepanel.comFor More Info Click Here\n\nFor more informat
 ion visit https://medtechiq.ning.com/events/quality-management-systems
 -creating-implementing-and-improving
DTSTART;TZID=America/New_York:20140814T100000
DTEND;TZID=America/New_York:20140814T110000
CATEGORIES:webinar, pharma, medical, clinical, health
LOCATION:Online Event
WEBSITE:http://bit.ly/1sQfMOW
URL:http://bit.ly/1sQfMOW
CONTACT:18004479407
ORGANIZER:GlobalCompliancePanel
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562011725?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob
 inson":https://medtechiq.ning.com/profile/JohnRobinson
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