BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T081630Z UID:7f61ff76-43f7-4ae2-9c43-d18da3521d75 DTSTART:20210409T083000 DTEND:20210410T083000 CLASS:PRIVATE DESCRIPTION:
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* LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! ***
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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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\nAGEND
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\n\n-------------  \;  \; Barry A. Friedman\, PhD\, is a Consu
ltant in the Biotechnology\, Regulatory Compliance and Aseptic Processing
Arena. Dr. Friedman possesses over 30 years of industrial managerial exper
ience in various aspects of biopharmaceuticals and medical devices to incl
ude regulatory compliance\, expert witness testimony\, GLP/GMP\, quality c
ontrol\, auditing\, sterility assurance\, microbiological/analytical valid
ations and fermentation technology. Prior to becoming an indepen
dent consultant\, Dr. Friedman was associated with Cambrex Bio Sciences\,
a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimor
e\, Maryland. As the Director of Quality Control\, he managed a multi-shif
t Department of thirty one individuals involved in client management\, the
receipt and testing of raw materials\, environmental monitoring and micro
biology\, analytical chemistry and QC compliance for the production of Pha
se 1\, 2\, 3 and commercial products manufactured from bacteria\, yeast an
d mammalian cells. In this capacity\, Dr Friedman enjoyed many client and
regulatory interactions\, both domestic and international. Prior
to 2000\, Dr. Friedman was the Laboratory Director for Chesapeake Biologi
cal Laboratories\, a contract Aseptic Fill n&rsquo\; Finish manufacturer l
ocated in Baltimore\, Maryland. In addition to the professional history li
sted above\, other associations have included W.R. Grace\, Sigma Chemical
Co.\, Sherwood Medical\, Becton Dickinson\, American Cyanamid and Union Ca
rbide. Dr. Friedman received his B.S. degree in Microbiology fro
m Ohio State University\, his M.S. from Michigan State University in Micro
bial Genetics\, and his PhD from Ohio State University in Microbiology.  \;  \; Please contact the event manag
er Marilyn (marilyn.b.turner(at)nyeventslist.com ) below for:
\nSPEAKER
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/p>\n\n
\nBarry A. Fried
man\, Ph.D
\nConsultant in Biotechnology\, Regulatory Compli
ance and Aseptic Processing Arena\n
\n- Mul
tiple participant discounts
\n- Price quotations or visa invitation l
etters
\n- Payment by alternate channels (PayPal\, check\, Western Un
ion\, wire transfers etc)
\n- Event sponsorships
\n
\nNO RE
FUNDS ALLOWED ON REGISTRATIONS
\nService fees included in this listin
g.
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EV MYL171201CHK CEC180223CHK \;JOA180315CEV