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UID:2140535:Event:68928
DTSTAMP:20260528T025516Z
SUMMARY:Webinar on Training Requirements under FDA's Quality System Re
 gulation
DESCRIPTION:Description :\nTraining requirements can make or break a f
 irm's compliance program. A weak training program becomes a weak link 
 in a firm's ability to make a product that conforms to FDA requirement
 s.\nAn effective training program should enhance and ensure a firm's r
 egulatory program and play a major role in supporting a firm's product
 , operations and the human factors environment. During an inspection, 
 the FDA investigator may think:\nDo these manufacturing employees know
  what they are doing?\nIs the CEO's secretary qualified to manage the 
 firm's Quality Assurance program?\nRejected products can be traced bac
 k to at least three employees X. Were they trained or retrained?\nThe 
 complaint file indicates product A is associated with a lot of serious
  injuries and recalls. Do the employees have the knowledge, training o
 r skills to design, make or evaluate product A?\nThis firm is mired in
  recalls. Does the firm have the technical knowledge and skill to iden
 tify the root cause and take corrective and preventive action?\nEmploy
 ee Z is making a lot of mistakes. Was Z trained or retrained and teste
 d? Is there on-the-job-training supervision?\n\nAreas Covered in the S
 ession :\nYou should understand how the QSR personnel training require
 ments directly or indirectly affect a firm's conformance to all QSR re
 quirements. The adequacy of training can bear on the quality of the pr
 oducts placed into the market. If your firm is involved with ongoing r
 ecalls or repetitive adverse events reports, then ask yourself whether
  employee training is related to a root cause?\nHow do you associate m
 anagement responsibilities with employee training? Is it an orphaned c
 onsideration? Employee training affects FDA's evaluation of a firm's o
 rganizational management, not just the training itself as on-the-job t
 raining, academic background, technical knowledge or skills. If an emp
 loyee training program is not robust, does that mean that the manageme
 nt does not really care in the first place? That is a fair question fo
 r the FDA investigator to ask.\nWho Will Benefit:\nManufacturing Senio
 r Managers and Supervisors\nQuality Control Managers\nQuality Assuranc
 e Managers and Auditors\nComplaint and Recall Managers\nProduct Design
  Engineers\nPersonnel Department Hiring Manager\nConsultants\n\nFor mo
 re information visit https://medtechiq.ning.com/events/webinar-on-trai
 ning-requirements-under-fda-s-quality-system
DTSTART;TZID=America/New_York:20160315T130000
DTEND;TZID=America/New_York:20160315T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=FDB1557
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=FDB1557
CONTACT:4169154458
ORGANIZER;CN=compliancetrainings:https://medtechiq.ning.com/profile/co
 mpliancetrainings
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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