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DESCRIPTION:Use coupon COMPLIANCE15 to get 15% discount on this virtual se
 minar\n\nRaw material requirements in a cGMP environment are often overlo
 oked as a Company develops new products. Depending upon the product being
  developed\, e.g.\, tablets and capsules vs. biotechnology products to in
 clude recombinant microorganisms and gene therapy products\, as few as fi
 fteen to twenty or as many as sixty raw materials need to be sourced befo
 re the process can be moved from initiation through completion.\n\nThis h
 ighly interactive two day seminar on raw material requirements in a cGMP 
 environment will:\n\n\nCompare and Contrast FDA\, Health Canada\, ICH\, U
 SP and EP requirements\nReview latest updates to include FDA\, Health Can
 ada\, ICH\, USP and EP requirements\nExamine a variety of the issues surr
 ounding raw materials to include what materials should be tested and to w
 hat extent during Phase 1\, 2\, 3 and commercial production.\nCover testi
 ng requirements during each Phase (Phase appropriate)\, to include microb
 ial and endotoxin\, and what may be optional (regulatory risk) until the 
 product moves to its next Phase.\nDetermine what options exist - even wit
 hin a Phase 2 or Phase 3 testing framework.\nDiscuss compendial vs. non-c
 ompendial testing and how to respond when no method is available.\nDiscus
 s how a 90 percent vs. a 90.0 percent minimum purity analysis can delay i
 nitiation of testing.\nExplore the number of lots required for testing be
 fore reduced testing might occur and why some companies don't accept this
  route.\nReview the use of individual samples vs. composite samples for t
 esting.\nReview packaging and storage requirements and their impact on in
 -coming materials to include both raw materials and API.\nExplore ASQ tes
 ting to include how to choose attributes and sample size.\nDetermine when
  the ASQ vs. square root of N+1 is appropriate.\n\nThe objective of this 
 FIVE HOUR/DAY\, ON-LINE two day highly interactive ComplianceOnline semin
 ar is to explore raw materials and their requirements – issues and soluti
 ons. It will also explore how water impacts the final product since water
  is the single largest raw material that is used within most processes. A
 nother objective is to assure that your organization is maintaining itsel
 f within a cGMP compliance framework to include ICH Q7\, Q9 and Q11. Case
  studies to include Warning Letters will be discussed to illustrate regul
 atory raw material issues.\n\n&nbsp\;\n\nLearning Objectives:\nUpon compl
 eting this course on raw material requirements in a cGMP environment part
 icipants will:\n\n\nUnderstand how various types of raw materials may imp
 act the user.\nLearn of the impact of raw materials to include any bacter
 ial and endotoxin issues in the timely production of a product.\nDetermin
 e the single most used raw material in large molecule production and what
  it means to the user.\nFind the sources of analyses assistance for raw m
 aterials.\nAppreciate the requirements for Phase 1 through commercial man
 ufacturing—why safety is required as part of Phase 1\nInitiation of addit
 ional testing -- when?\nExamination of regulatory risk to include ICH Q7\
 , Q9 and Q11.\nWhy use compendial testing in lieu non-compendial testing.
 \nTesting requirements -- when is enough?\nUnderstand packaging and stora
 ge requirements and their impact on in-coming materials to include both r
 aw materials and API.\nThe impact of ASQ vs. square root of N+1 on sample
  size and attribute testing.\n\nWho Will Benefit:\nThose who will benefit
  from this ON-LINE seminar include:\n\n\nQuality professionals\nRegulator
 y professionals\nCompliance professionals\nManufacturing engineers\nQuali
 ty engineers\nQuality auditors\nQuality Control\nMicrobiology\nIn-coming 
 Materials\nDocument control specialists\nR &amp\; D\nProject Managers\n
DTEND:20260327T170000
DTSTAMP:20260512T214935Z
DTSTART:20260326T110000
LOCATION:\,
SEQUENCE:0
SUMMARY:Use coupon COMPLIANCE15 to get 15% discount on this virtual semina
 r\nRaw material requirements in a cGMP environment are often overlooked a
 s a Comp...
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