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DTSTART:19700308T020000
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DTSTAMP:20260410T062915Z
SUMMARY:Raw Material Requirements
DESCRIPTION:Raw material requirements in a cGMP environment are often 
 overlooked as a Company develops new products. Depending upon the prod
 uct being developed, e.g., tablets and capsules vs. biotechnology prod
 ucts to include recombinant microorganisms and gene therapy products, 
 as few as fifteen to twenty or as many as sixty raw materials need to 
 be sourced before the process can be moved from initiation through com
 pletion.\nThis highly interactive two day seminar on raw material requ
 irements in a cGMP environment will:\n\nCompare and Contrast FDA, Heal
 th Canada, ICH, USP and EP requirements\nReview latest updates to incl
 ude FDA, Health Canada, ICH, USP and EP requirements\nExamine a variet
 y of the issues surrounding raw materials to include what materials sh
 ould be tested and to what extent during Phase 1, 2, 3 and commercial 
 production.\nCover testing requirements during each Phase (Phase appro
 priate), to include microbial and endotoxin, and what may be optional 
 (regulatory risk) until the product moves to its next Phase.\nDetermin
 e what options exist - even within a Phase 2 or Phase 3 testing framew
 ork.\nDiscuss compendial vs. non-compendial testing and how to respond
  when no method is available.\nDiscuss how a 90 percent vs. a 90.0 per
 cent minimum purity analysis can delay initiation of testing.\nExplore
  the number of lots required for testing before reduced testing might 
 occur and why some companies don't accept this route.\n\nLearning Obje
 ctives:\nUpon completing this course on raw material requirements in a
  cGMP environment participants will:\n\nUnderstand how various types o
 f raw materials may impact the user.\nLearn of the impact of raw mater
 ials to include any bacterial and endotoxin issues in the timely produ
 ction of a product.\nDetermine the single most used raw material in la
 rge molecule production and what it means to the user.\nFind the sourc
 es of analyses assistance for raw materials.\nAppreciate the requireme
 nts for Phase 1 through commercial manufacturing—why safety is requi
 red as part of Phase 1\nInitiation of additional testing -- when?\nExa
 mination of regulatory risk to include ICH Q7, Q9 and Q11.\nWhy use co
 mpendial testing in lieu non-compendial testing.\nTesting requirements
  -- when is enough?\n\nWho Will Benefit:\nThose who will benefit from 
 this ON-LINE seminar include:\n\nQuality professionals\nRegulatory pro
 fessionals\nCompliance professionals\nManufacturing engineers\nQuality
  engineers\nQuality auditors\nQuality Control\n\n\nFor more informatio
 n visit https://medtechiq.ning.com/events/raw-material-requirements
DTSTART;TZID=America/New_York:20220228T100000
DTEND;TZID=America/New_York:20220301T160000
CATEGORIES:seminae
LOCATION:online
WEBSITE:https://www.complianceonline.com/raw-material-requirements-hea
 lth-canada-usp-ep-in-a-cgmp-environment-issues-and-solutions-seminar-t
 raining-80218SEM-prdsm?channel=MedTech%20I.Q
URL:https://www.complianceonline.com/raw-material-requirements-health-
 canada-usp-ep-in-a-cgmp-environment-issues-and-solutions-seminar-train
 ing-80218SEM-prdsm?channel=MedTech%20I.Q
CONTACT:8887172436
ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer
 ral512
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/9839250497?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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