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DTSTAMP:20260519T170600Z
SUMMARY:Online Webinar on Good Documentation Practice for GxP Environm
 ents in September
DESCRIPTION:Overview: This webinar will cover Good Documentation Pract
 ice for GxP environments. This webinar will explore what companies nee
 d to know to comply with regulations regarding documentation, what Goo
 d Documentation Practice (GDP) is, what needs to be documented, why it
  is documented, and FDA expectations for documentation.\nWhy should yo
 u Attend: In today's strict regulatory environment it is more importan
 t than ever for companies and individuals to understand and practice g
 ood documentation to comply with FDA regulatory requirements. This web
 inar will cover Good Documentation Practice for GxP environments. Unde
 rstand what needs to be documented, what FDA looks for in documentatio
 n, relevant regulations for documentation, and related guidances.\nAre
 as Covered in the Session:FDA 101: who is the FDA, regulations, guidan
 ces, documentation and industryWhy document?What needs to be documente
 d?What documentation does FDA look for during an inspection?What do th
 e GMP, GCP, and GLP regulations and guidances say about documentation?
 Examples and exercises for good documentationSummary/ Q&A\nWho Will Be
 nefit:GxP personnel involved with GxP DocumentationR&DProductionQualit
 yRegulatory\nSpeaker Profile:John R. Godshalk currently works for the 
 Biologics Consulting Group as a Senior Consultant. John served as a Se
 nior Review Biochemical Engineer and Lead cGMP inspector in the Divisi
 on of Manufacturing and Product Quality at CBER, FDA. He contributed t
 o formulation of FDA policy. He has audited/inspected hundreds of phar
 ma and biotech companies and reviewed processes and PV at these plants
 . John has provided advice to industry on regulatory strategies, pharm
 aceutical product facility design, best practices, and validation appr
 oaches that meet FDA licensing requirements.\nContact Detail:\nComplia
 nce4All DBA NetZealous,Phone: +1-800-447-9407Email: support@compliance
 4All.comhttp://www.compliance4all.com/Event Link : http://bit.ly/29J3
 KiOTwitter Follow us – https://twitter.com/compliance4allFacebook L
 ike us – https://www.facebook.com/Compliance4allPinterest - https:
 //in.pinterest.com/compliance4all/\n\nFor more information visit https
 ://medtechiq.ning.com/events/online-webinar-on-good-documentation-prac
 tice-for-gxp
DTSTART;TZID=America/New_York:20160915T100000
DTEND;TZID=America/New_York:20160915T110000
CATEGORIES:webinar
LOCATION:Online Event
WEBSITE:http://bit.ly/29J3KiO
URL:http://bit.ly/29J3KiO
CONTACT:18004479407
ORGANIZER:Compliance4All
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562012364?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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