BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240328T085754Z UID:8320d5aa-86cc-4f2d-b5db-a5027cfc497d DTSTART:20210409T083000 DTEND:20210410T083000 CLASS:PRIVATE DESCRIPTION:
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\n\nThe Process Valid ation Guidelines (January 2011) and the EU Annex 15: Qualification and Val idation (October 2021) outline the general principles and approaches the t wo regulatory bodies consider appropriate elements of process validation f or the manufacture of human and animal drugs and biological products\, inc luding Active Pharmaceutical Ingredients (APIs). These guidances align Pro cess Validation activities with a product lifecycle concept and with exist ing FDA and EU guidances\, including the FDA/International Conference on H armonization (ICH)\, Guidance for Industry\, Q8 (R2) Pharmaceutical Develo pment\, Q9 Quality Risk Management\, and Q10 Pharmaceutical Quality System . The lifecycle concept\, new to these Guidances\, link product and proces s development\, qualification of the commercial manufacturing process\, an d maintenance of the process in a state of control during routine commerci al production. These guidances also support process improvement and innova tion through sound science and risk management. The new Process Validation Guideline/Practice incorporate elements of Process Validation as early as the Research and Development phase\, and continues onward through Technol ogy Transfer\, into the Phase 1 IND Clinical Trial manufacturing phase\, a nd ultimately into Phase 2 and 3\, and then commercial manufacturing.
\ n\nEach facility\, whether producing small or large molecules requires both an overall Site Validation Plan as well as specific validation plans to manage the multiplicity of validations required to confirm the successf ul manufacture of each of its products.
\nThis two day\, interactive S eminar which provides a conduit to enhance your understanding of the Conti nued Process Verification\, will be reviewed in detail: where does it begi n\; what is included\; and\, when does it end.
\n\nCommon questions asked by the users of Process Validation include\;
\n\nThese questions will be addressed within Stage 2 as presented here and include utilization of Process Validation and Phase 1\, 2 and 3\, where th eir Guidances blend and where they remain distinct. In particular\, Stage 3.
\n\nImportant: Please plan to bring a multidisciplinary group fro m your Company to gain the most from this very important seminar.
\n&nb sp\;\n\nWhy these FDA Guidance/EU Guidelines for Industry - Process Validation is so importa nt to the pharmaceutical and biotechnology industry.
\n\nThose who will benefit from th is seminar include
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\nSPEAKER
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\nBarry A. Friedman\, PhD\, is a Consulta nt in the Biotechnology\, Regulatory Compliance and Aseptic Processing Are na. Dr. Friedman possesses over 30 years of industrial managerial experien ce in various aspects of biopharmaceuticals and medical devices to include regulatory compliance\, expert witness testimony\, GLP/GMP\, quality cont rol\, auditing\, sterility assurance\, microbiological/analytical validati ons and fermentation technology.
\n\nPrior to becoming an independen t consultant\, Dr. Friedman was associated with Cambrex Bio Sciences\, a c ontract manufacturer of GMP bulk biopharmaceuticals located in Baltimore\, Maryland. As the Director of Quality Control\, he managed a multi-shift D epartment of thirty one individuals involved in client management\, the re ceipt and testing of raw materials\, environmental monitoring and microbio logy\, analytical chemistry and QC compliance for the production of Phase 1\, 2\, 3 and commercial products manufactured from bacteria\, yeast and m ammalian cells. In this capacity\, Dr Friedman enjoyed many client and reg ulatory interactions\, both domestic and international.
\n\nPrior to 2000\, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories\, a contract Aseptic Fill n&rsquo\; Finish manufacturer loca ted in Baltimore\, Maryland. In addition to the professional history liste d above\, other associations have included W.R. Grace\, Sigma Chemical Co. \, Sherwood Medical\, Becton Dickinson\, American Cyanamid and Union Carbi de.
\n\nDr. Friedman received his B.S. degree in Microbiology from O hio State University\, his M.S. from Michigan State University in Microbia l Genetics\, and his PhD from Ohio State University in Microbiology.
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