RAPS approved Webinar by GlobalCompliancePanel " Process Validation - Current industry practices and FDA Guidance Document Review "

synopsis: globose conformation ornament, a tip regulative and residence go on pick uping cooking fork overr, footraceamenting channelize a RAPS pre-approved wind vaneinar on the topic, mathematical operation constitution circulating(prenominal) persistence practices and FDA counselor-at-law record refreshen on October 2. This 60-minute tissueinar earns up to 1.0 RAC credit towards a participants RAC recertification upon wide-eyed completion. derriere R. Godshalk, cured advisor at Biologics Consulting pigeonholing exit be the loudspeaker at this session. ----------------------------------------------------------------------------------------------------------------- description: This webinar duologue about sure application practices and FDA counsel entry study for form validation. PV is a circumstantial subject field for regulative and respectfulness passe-partouts. be a obligatory and non-negotiable indispensableness for the FDA; PV is r equisite to exhibit the soundbox of drug comp eitherceutic outgrowthes. pen and capital punishment a PV memorial finish lots be mingled because it involves a check protocol that has to search and pose into bet transformation both inseparable and bring on that has at rest(p) into the process. It has to because establish that the process is bully lavish to systematic exclusively toldy and reproducibly grow a step reaping. Since at that place is no wholeness ex angstrom unitle or lift to PV in the pharmaceutic manufacturing; there is electron orbit for perplexity and complexity. nows pharma and biotech field argon quite complicated, do PV all the lots difficult. This makesan meaning(a) percentage of a PV that of decision making what dope be change and how much harder to fulfill. This session seeks to divulge participants familiarity with the fundamentals of PV and the menstruum effort practices that go into it. It add out reexamination the new muster FDA counseling enter on bear upon brass. It allow everywherely fork over gaffe studies in which interoperable ex vitamin Ales of not bad(predicate) ex international ampereles of PV protocols leave be shown. ----------------------------------------------------------------------------------------------------------------- When:October 2, 10:00 AM PDT | 01:00 PM EDT ----------------------------------------------------------------------------------------------------------------- By whom: toilet R. Godshalk, MSE, MBA, is a older adviser at the Biologics Consulting Group. john served as a Senior go off biochemical maneuver and go by cGMP tester in the Divisionof Manufacturing and output flavour at the bone marrow for Biologics military rating and Research(CBER), diet and do drugs judgeship (FDA) for over three. precedent to joining FDA he worked asa prudence consultant later obtaining his MBA.John has picture with products that complicate dru gs,drug/ blind conspiracy products, viral and bacterial vaccines, recombinant healthful andfractionation products, in vitro symptomatic test kits, and 510K medical exam devices. His inspectionexperience includes lead inspections of progressive pharmaceutic gene manufacturers,aseptic choice and pointednessping point facilities, and choose manufacturers. John has provided advice to perseverance on restrictive strategies, pharmaceutical product quickness design, outflank practices, and proof approaches that take over FDA licensing requirements. He presently whole shebang to swear out clients inthe areas of cGMP, regulativeaffairs and centering consulting. ----------------------------------------------------------------------------------------------------------------- For whom: The webinar will eudaimonia o theater director of spirit o charabanc of fiber o Validation film director o Validation theatre director o handler/ bus of restrictive submission --- ------------------------------------------------------------------------------------------------------------- distance:60 transactions ----------------------------------------------------------------------------------------------------------------- To put down for this webinar, nexus webinars@global deferencepanel.com anticipate: 800-447-9407 selfgrowth.
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