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DTSTART:19700308T020000
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DTSTAMP:20260415T230314Z
SUMMARY:Batch Record Review and Product Release
DESCRIPTION:Overview:Most Regulatory Agencies require firms to have wr
 itten procedures in place to document production and process controls,
  better known as batch records. Additionally, there must be written pr
 ocedures for a batch record review process that demonstrate compliance
 .\nA strong batch record review system is essential in order to proper
 ly document all critical processing parameters that go along with the 
 production and manufacture of pharmaceuticals, biologics, medical devi
 ces, etc. This webinar will analyze each of these necessary elements o
 f the batch record review process.Why you should Attend: Recognize re
 gulatory requirements for batch records and batch record review. Disco
 ver the essentials of batch record reviewer qualifications and trainin
 g. Establish a working relationship between production and quality rev
 iewers What to do when a batch fails to meet specifications (discrepan
 cies and deviations).Areas Covered in the Session:\n\nRegulatory requi
 rements for Batch Record Review\nWhat to look for while reviewing batc
 h records, i.e Good Documentation Practices, Compliance to Critical Qu
 ality Attributes and Critical Processing Parameters\nSkills and Respon
 sibilities of an Effective Batch Record Reviewer\nTools for Effective 
 Batch Record Review\nEnsuring Production and Quality Reviewers Coincid
 e with their Reviews\nExtensive Training plan for Batch Record Reviewe
 rs and when they can be Considered \"Qualified\" to Review a Record\n\
 nWho Will Benefit:\n\nQuality Assurance Batch Record Reviewers\nProduc
 tion Personnel\nProduction Managers who Review Batch Records\n\n\n\n\n
 Speaker ProfileDanielle DeLucy MS, is owner of ASA Training and Consu
 lting, LLC which provides Pharmaceutical and Biologics based companies
  with training and quality systems assistance in order to meet Regulat
 ory compliance. Prior to this role, Danielle has been in the industry 
 for 17 years serving in numerous Quality Management Roles, such as the
  Director of Product Quality, the oversight of Sterility Assurance pra
 ctices and provided QA oversight of numerous filling and packaging ope
 rations.Danielle began her QA career as a Quality Control Pharmaceutic
 al Microbiologist at a contract laboratory where she performed various
  tests for their clients. In the years after, she has held positions i
 n the Quality management arena while increasing her responsibility.She
  has helped to lead many Regulatory Health Inspections and was instrum
 ental in the coaching process of her peers prior to any inspection. Cu
 rrently, Danielle assists companies who are faced with warning letters
 , consent decrees and those wishing to improve compliance establish mo
 re robust quality systems so that the company can succeed.\n\nEvent li
 nk:\nhttps://www.compliance4all.com/webinar/-502992LIVE?channel=medtec
 hiq-May_2020_SEO\nContact Info\nNetzealous LLC, DBA -Compliance4all\nE
 mail: support@compliance4All.com\nPhone: +1-800-447-9407\nWebsite: htt
 ps://www.compliance4all.com/\n\n\n\nFor more information visit https:/
 /medtechiq.ning.com/events/batch-record-review-and-product-release
DTSTART;TZID=America/New_York:20200507T100000
DTEND;TZID=America/New_York:20200507T130000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://www.compliance4all.com/webinar/batch-record-review-and
 -product-release-502992LIVE
URL:https://www.compliance4all.com/webinar/batch-record-review-and-pro
 duct-release-502992LIVE
CONTACT:8004479407
ORGANIZER:Compliance4all
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/2647295700?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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