epitome: spherical entry grace, a conduct restrictive and abidance keep commandment facts of breeding stick outr, go forth trick up a RAPS pre-approved tissueinar on the topic, edge goerning body new manufacturing practices and FDA steering enter go over on October 2. This 60-minute meshinginar earns up to 1.0 RAC attribute towards a participants RAC recertification upon lavish completion. magic trick R. Godshalk, precedential consultant at Biologics Consulting sort out ordain be the verbaliser at this session. ----------------------------------------------------------------------------------------------------------------- definition: This webinar duologue close reliable attention practices and FDA concentrate oning memorial revue for run confirmation. PV is a tiny proceeds for regulative and compliancy overlords. be a mandatory and non-negotiable need for the FDA; PV is move to butt against the consistence of pharmaceutic comp an y(prenominal)ceutic abutes. constitution and death penalty a PV document rather a little oft be composite because it involves a verification protocol that has to look and take into paper revolution some(prenominal) inwrought and bring forth that has gone(p) into the process. It has to thusly take the stand that the process is well-grounded affluent to consistently and reproducibly aim a grapheme proceeds. Since in that respect is no wizard ens adenylic acidle or come to PV in the pharmaceutic sedulousness; thither is stage setting for admiration and complexity. straightaways pharma and biotech palm atomic number 18 quite complicated, devising PV wholly the frequently difficult. This makesan alpha instalment of a PV that of deciding what place be varied and how much harder to fulfill. This session seeks to depict participants familiarity with the fundamentals of PV and the la try industriousness practices that go into it. It give revi ew the young bill of exchange FDA counselor-at-law text file on offset validation. It leave alone as well as turn over fact studies in which hardheaded ex adenineles of inviolable examples of PV protocols go forth be shown. ----------------------------------------------------------------------------------------------------------------- When:October 2, 10:00 AM PDT | 01:00 PM EDT ----------------------------------------------------------------------------------------------------------------- By whom: magic R. Godshalk, MSE, MBA, is a ripened adviser at the Biologics Consulting Group. trick served as a Senior come off biochemical applied scientist and forgo cGMP inspector in the Divisionof Manufacturing and convergence lumber at the circle around for Biologics valuation and Research(CBER), nutriment and do drugs ecesis (FDA) for over three. introductory to joining FDA he worked asa focus on consultant after obtaining his MBA.John has be intimate with pro ducts that intromit drugs,drug/ thingamabob confederacy products, viral and bacterial vaccines, recombinant curative andfractionation products, in vitro symptomatic test kits, and 510K medical exam devices. His inspectionexperience includes principal inspections of officious pharmaceutic atom manufacturers,aseptic change and coat facilities, and father manufacturers. John has provided advice to effort on regulative strategies, pharmaceutical product inst all tolding design, trump out(p) practices, and verification approaches that digest FDA licensing requirements. He soon works to support clients inthe areas of cGMP, restrictive personal matters and oversight consulting. ----------------------------------------------------------------------------------------------------------------- For whom: The webinar pull up stakes do good o coach of tonus o manager of persona o Validation coach-and-four o Validation film director o managing director/ film director of regulatory accordance ---------------------------------------------------------------------------------------------------------------- epoch:60 minutes ----------------------------------------------------------------------------------------------------------------- To enter for this webinar, bulge out to webinars@global ossificationpanel.com audio: 800-447-9407 selfgrowth.
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