BEGIN:VCALENDAR
PRODID:NingEventWidget-v1
VERSION:2.0
METHOD:PUBLISH
BEGIN:VTIMEZONE
TZID:America/New_York
X-LIC-LOCATION:America/New_York
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:19700308T020000
RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:19701101T020000
RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
UID:2140535:Event:472206
DTSTAMP:20260603T162907Z
SUMMARY:Major CGMP Issues - US FDA Concerns in 2022
DESCRIPTION:This webinar will evaluate the chief areas of FDA CGMP and
  EU compliance inspections to see actual and anticipated changes in em
 phasis, and how to better prepare with a company's proactive internal 
 inspection / audit program.\n\nWhy Should You Attend:\nA review of rec
 ent US FDA Inspectional Observations / FDA Form 483 Observations, as w
 ell as FDA statements and actions, indicate the major areas of regulat
 ory concern. The past is no indicator of present or future concerns. T
 he Agency uses publicized high-profile cases to drive compliance in th
 e regulated industries. Certain CGMP areas, e.g., CAPA, are receiving 
 increased scrutiny. \"Risk-based\" (patient risk) is another. Failure 
 to correct problems leads to Warning Letters or more severe regulatory
  actions. Requirement for \"better science\" must be evident in compli
 ance. \"Business as usual\" is never acceptable, but do some of a comp
 any’s documents reflect that outdated thinking. Also changes from th
 e EU, MDD to MDR, ISO 13485:2016 ... confusion over what is \"Risk\". 
 Don't be caught off guard by these major shifts in emphasis. Refine in
 ternal audits and get your company prepared to address the FDA's most 
 recent requirements both in the US and outside.\nThis tougher emphasis
  also affects clinical trial expectations, product submissions and com
 pany response requirements. This change has a major impact on individu
 al compliance objectives, efforts and measurements of success. The def
 inition of \"Risk\" in systems and documentation can make the differen
 ce in a \"Pass\" or \"Fail\" regulatory inspection.\n\nAreas Covered i
 n the Webinar:\n\nRecent industry trends, bad and good\nThe FDA’s St
 rategic Priorities\nMajor foreseeable problem areas for 2022 onward - 
 The \"Heavy Hitters\"\nA company gap analysis\nCorrecting problem-pron
 e areas\nAvoid complacency from past “good” audits\n\nWho Will Ben
 efit:\n\nSenior Management\nRegulatory Affairs\nQuality Assurance\nPro
 duction\nR&D and Engineering\n\n\nFor more information visit https://m
 edtechiq.ning.com/events/major-cgmp-issues-us-fda-concerns-in-2022
DTSTART;TZID=America/New_York:20220531T100000
DTEND;TZID=America/New_York:20220531T130000
CATEGORIES:seminae
LOCATION:online
WEBSITE:https://www.complianceonline.com/major-cgmp-issues-in-2022-web
 inar-training-702185-prdw?channel=MedTech%20I.Q
URL:https://www.complianceonline.com/major-cgmp-issues-in-2022-webinar
 -training-702185-prdw?channel=MedTech%20I.Q
CONTACT:8887172436
ORGANIZER:Complianceonline
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/10434360882?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
END:VEVENT
END:VCALENDAR