BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240319T114720Z UID:98ee885b-879b-49a7-be03-1f87e4942fd3 DTSTART:20210507T083000 DTEND:20210508T083000 CLASS:PRIVATE DESCRIPTION:
Raw material requirements in a cGMP environment are often overlooked as a Company develops new product s. Depending upon the product being developed\, e.g.\, tablets and capsule s vs. biotechnology products to include recombinant microorganisms and gen e therapy products\, as few as fifteen to twenty or as many as sixty raw m aterials need to be sourced before the process can be moved from initiatio n through completion.
\n\nThis highly interactive two day seminar on raw material requirements in a cGMP environment will:
\n\nThe objective of this two day highly interactive ComplianceOnline seminar is to explore raw materia ls and their requirements &ndash\; issues and solutions. It will also expl ore how water impacts the final product since water is the single largest raw material that is used within most processes. Another objective is to a ssure that your organization is maintaining itself within a cGMP complianc e framework to include ICH Q7\, Q9 and Q11. Case studies to include Warnin g Letters will be discussed to illustrate regulatory raw material issues.< /p>\n \;\n\n
Upon completing this c ourse on raw material requirements in a cGMP environment participants will :
\n\nAGENDA
\nDAY 01(8:30 AM - 4:30 PM)SPEAKER
\nBarry A. Friedman\, PhD\, is a Consultant in the Biotech nology\, Regulatory Compliance and Aseptic Processing Arena. Dr. Friedman possesses over 30 years of industrial managerial experience in various asp ects of biopharmaceuticals and medical devices to include regulatory compl iance\, expert witness testimony\, GLP/GMP\, quality control\, auditing\, sterility assurance\, microbiological/analytical validations and fermentat ion technology.
\n\nPrior to becoming an independent consultant\, Dr . Friedman was associated with Cambrex Bio Sciences\, a contract manufactu rer of GMP bulk biopharmaceuticals located in Baltimore\, Maryland. As the Director of Quality Control\, he managed a multi-shift Department of thir ty one individuals involved in client management\, the receipt and testing of raw materials\, environmental monitoring and microbiology\, analytical chemistry and QC compliance for the production of Phase 1\, 2\, 3 and com mercial products manufactured from bacteria\, yeast and mammalian cells. I n this capacity\, Dr Friedman enjoyed many client and regulatory interacti ons\, both domestic and international.
\n\nPrior to 2000\, Dr. Fried man was the Laboratory Director for Chesapeake Biological Laboratories\, a contract Aseptic Fill n&rsquo\; Finish manufacturer located in Baltimore\ , Maryland. In addition to the professional history listed above\, other a ssociations have included W.R. Grace\, Sigma Chemical Co.\, Sherwood Medic al\, Becton Dickinson\, American Cyanamid and Union Carbide.
\n\nDr. Friedman received his B.S. degree in Microbiology from Ohio State Univers ity\, his M.S. from Michigan State University in Microbial Genetics\, and his PhD from Ohio State University in Microbiology.
\n\nPlease conta
ct the event manager Marilyn (marilyn.b.turner(at)nyeventslist.com ) below
for: \;
\n- Multiple participant discounts \;
\n- Price
quotations or visa invitation letters \;
\n- Payment by alternat
e channels (PayPal\, check\, Western Union\, wire transfers etc) \;
\n- Event sponsorship \;
\n
\nNO REFUNDS ALLOWED ON REGIS
TRATIONS \;
\nPrices may go up any time. Service fees included in
pricing. \;
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\n SUMMARY:Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environm ent - Issues and Solutions BEGIN:VALARM ACTION:DISPLAY TRIGGER:-PT1H SUMMARY:Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environm ent - Issues and Solutions END:VALARM END:VEVENT END:VCALENDAR