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UID:2140535:Event:468449
DTSTAMP:20260410T042640Z
SUMMARY:FDA Audit, Quality Assurance Practices, Responsibilities and E
 xpectations
DESCRIPTION:It is no surprise to anyone who reviews regulatory citatio
 ns to notice the number of deficiencies cited that are associated with
  quality systems. Today, the basis for all FDA audits both within th
 e US and internationally is based on the quality systems approach and 
 the six systems that comprise it. Whether the audit is a full or parti
 al audit, the quality system within a company will always be inspected
  and this seminar will help review what are the expectations and the c
 ommon areas to be familiar with. As a basis for regulatory audits, th
 e quality system, its procedures and their implementation are reviewed
  to help verify the level of effectiveness in assuring consistent cont
 rol and quality of materials, components and final product.\nThis trai
 ning will examine the differences between Quality Assurance and Qualit
 y Control and the responsibilities of each. In addition, attendees wil
 l discuss what characteristics quality personnel should possess. The c
 urrent expectations for an effective quality system program as defined
  in both the FDA and EU requirements and guidance documents will b
 e reviewed. Topics to be covered will range from the development of a 
 quality manual and procedures, the importance and scope of audits (int
 ernal, vendor, third party and regulatory) along with review of variou
 s case studies to help further illustrate points discussed.\nThe quali
 ty department within companies is responsible for nearly all activitie
 s to various degrees that have impact on the quality, safety or effica
 cy of the final product or material produced. It is also responsible f
 or helping assure that contracted services, which is more common today
  than ever before, are also verified to meet the quality standards set
  both by the company and the regulatory requirements. The training wil
 l review special topics of interest to auditors such as CAPA programs
  and investigations that address deviations and out of specification
  (OOS) results. Attendees will be given ample opportunity to ask ques
 tions, discuss actual case studies and to learn about the vast scope o
 f responsibility that the quality system regulations expect and the ro
 les of their own positions..\nLearning Objectives:\nUpon completing th
 is course participants should:\n\n\nUnderstand the regulatory expectat
 ions of the quality unit and its role in the Quality System Requiremen
 ts (QSR)\nReview the Quality areas that are the point of focus during 
 regulatory, corporate or third party audits.\nReview typical checklist
  that can be used as a template for the performance of audits\nEvaluat
 e the importance of training, its documentation, and common concerns b
 eing raised over \"operator error\"\nReview the importance and regulat
 ory guidance offered for the investigation of deviations/out-of-specif
 ication results.\n\n\n\nWho will Benefit:\nThis course is designed for
  people within the quality unit, those impacted by quality requirement
 s, third party suppliers who are evaluated against quality issues and 
 their adherence to them, along corporate management who is required to
  provide the time and resources to correct quality issues identified. 
 This includes individuals that have Quality Management Systems respons
 ibilities for making general improvements in their organization's perf
 ormance. Following personnel will benefit from the course:\n\nSenior q
 uality managers\nQuality professionals\nRegulatory professionals\nComp
 liance professionals\nProduction supervisors\nManufacturing engineers\
 n\n\nFor more information visit https://medtechiq.ning.com/events/fda-
 audit-quality-assurance-practices-responsibilities-and-1
DTSTART;TZID=America/New_York:20210520T090000
DTEND;TZID=America/New_York:20210521T170000
CATEGORIES:seminae
LOCATION:online
WEBSITE:https://www.complianceonline.com/fda-eu-audit-quality-assuranc
 e-qsr-seminar-training-80474SEM-prdsm?channel=MedTech%20I.Q
URL:https://www.complianceonline.com/fda-eu-audit-quality-assurance-qs
 r-seminar-training-80474SEM-prdsm?channel=MedTech%20I.Q
CONTACT:8887172436
ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer
 ral512
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 /file/get/8927926698?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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