{"id":302,"date":"2025-04-07T07:51:08","date_gmt":"2025-04-07T05:51:08","guid":{"rendered":"https:\/\/www.asinfarma.com\/aulavirtual360\/?p=302"},"modified":"2025-04-09T17:44:13","modified_gmt":"2025-04-09T15:44:13","slug":"anexo-1-gmp-esteriles","status":"publish","type":"post","link":"https:\/\/www.asinfarma.com\/aulavirtual360\/anexo-1-gmp-esteriles\/","title":{"rendered":"Anexo 1 GMP Est\u00e9riles"},"content":{"rendered":"\n<div class=\"wp-block-group has-global-color-15-background-color has-background\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<p><strong>INFORMACI\u00d3N ORGANIZATIVA<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>T\u00edtulo<\/strong>: Anexo 1 GMP Est\u00e9riles<\/li>\n\n\n\n<li><strong>Modalidad<\/strong>: virtual asincr\u00f3nico<\/li>\n\n\n\n<li><strong>Horas lectivas<\/strong>: 8 hr<\/li>\n\n\n\n<li><strong>Duraci\u00f3n del curso<\/strong>: 30 d\u00edas<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<p><strong>DESCRIPCI\u00d3N DEL CURSO<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Nivel t\u00e9cnico<\/strong>: Avanzado<\/li>\n<\/ul>\n\n\n<div class=\"su-expand su-expand-collapsed su-expand-link-style-button\" data-height=\"100\"><div class=\"su-expand-content su-u-trim\" style=\"color:#333333;max-height:100px;overflow:hidden\">\n\n\n\n<p>Este curso t\u00e9cnico proporciona una visi\u00f3n detallada y profunda de la versi\u00f3n vigente (2022) del Anexo 1 de las EU GMP. El curso aborda el impacto en la fabricaci\u00f3n de medicamentos est\u00e9riles. A trav\u00e9s de 16 m\u00f3dulos, se analizan en profundidad los principios regulatorios, los requisitos t\u00e9cnicos, operativos y de calidad aplicables al entorno est\u00e9ril, desde la estrategia de control de la contaminaci\u00f3n (CCS) hasta la validaci\u00f3n de procesos, cualificaci\u00f3n de salas, tecnolog\u00edas de barrera y simulaciones de procesos as\u00e9pticos (APS).<\/p>\n\n\n\n<p>El contenido est\u00e1 dise\u00f1ado para profesionales con experiencia previa en entornos regulados que necesitan adaptar sus procesos, instalaciones, documentaci\u00f3n y sistemas de calidad a los requerimientos m\u00e1s exigentes del sector farmac\u00e9utico.<\/p>\n\n\n<\/div><div class=\"su-expand-link su-expand-link-more\" style=\"text-align:left\"><a href=\"javascript:;\" style=\"color:#176585;border-color:#176585\"><i class=\"sui sui-plus\" style=\"\" aria-label=\"\"><\/i><span style=\"border-color:#176585\">Mostrar m\u00e1s<\/span><\/a><\/div><div class=\"su-expand-link su-expand-link-less\" style=\"text-align:left\"><a href=\"javascript:;\" style=\"color:#176585;border-color:#176585\"><i class=\"sui sui-minus\" style=\"\" aria-label=\"\"><\/i><span style=\"border-color:#176585\">Mostrar menos<\/span><\/a><\/div><\/div>\n<\/div>\n<\/div>\n<\/div><\/div>\n\n\n<span class=\"su-lightbox\" data-mfp-src=\"#formulario-inscripcion\" data-mfp-type=\"inline\" data-mobile=\"yes\">\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-16018d1d wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button has-custom-font-size has-medium-font-size\"><a class=\"wp-block-button__link has-base-3-color has-global-color-10-background-color has-text-color has-background has-link-color has-text-align-center wp-element-button\"><strong>Solicitar acceso a este curso<\/strong><\/a><\/div>\n<\/div>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<\/span>\n\n\n<div class=\"su-lightbox-content su-u-trim \" id=\"formulario-inscripcion\" style=\"display:none;width:auto;min-width:none;max-width:600px;margin-top:40px;margin-bottom:40px;padding:40px;background:#FFFFFF;color:#333333;box-shadow:0px 0px 15px #333333;text-align:center\">\n\n\n\n<div class=\"wp-block-contact-form-7-contact-form-selector\">\n<div class=\"wpcf7 no-js\" id=\"wpcf7-f359-o1\" lang=\"es-ES\" dir=\"ltr\" data-wpcf7-id=\"359\">\n<div class=\"screen-reader-response\"><p role=\"status\" aria-live=\"polite\" aria-atomic=\"true\"><\/p> <ul><\/ul><\/div>\n<form action=\"\/aulavirtual360\/wp-json\/wp\/v2\/posts\/302#wpcf7-f359-o1\" method=\"post\" class=\"wpcf7-form init\" aria-label=\"Formulario de contacto\" enctype=\"multipart\/form-data\" novalidate=\"novalidate\" data-status=\"init\">\n<fieldset class=\"hidden-fields-container\"><input type=\"hidden\" name=\"_wpcf7\" value=\"359\" \/><input type=\"hidden\" name=\"_wpcf7_version\" value=\"6.1.6\" \/><input type=\"hidden\" name=\"_wpcf7_locale\" value=\"es_ES\" \/><input type=\"hidden\" name=\"_wpcf7_unit_tag\" value=\"wpcf7-f359-o1\" \/><input type=\"hidden\" name=\"_wpcf7_container_post\" value=\"0\" \/><input type=\"hidden\" name=\"_wpcf7_posted_data_hash\" value=\"\" \/><input type=\"hidden\" name=\"_wpcf7cf_hidden_group_fields\" value=\"[]\" \/><input type=\"hidden\" name=\"_wpcf7cf_hidden_groups\" value=\"[]\" \/><input type=\"hidden\" name=\"_wpcf7cf_visible_groups\" value=\"[]\" \/><input type=\"hidden\" name=\"_wpcf7cf_repeaters\" value=\"[]\" \/><input type=\"hidden\" name=\"_wpcf7cf_steps\" value=\"{}\" \/><input type=\"hidden\" name=\"_wpcf7cf_options\" value=\"{&quot;form_id&quot;:359,&quot;conditions&quot;:[{&quot;then_field&quot;:&quot;grupo-tipo-inscripcion&quot;,&quot;and_rules&quot;:[{&quot;if_field&quot;:&quot;tipo-inscripcion&quot;,&quot;operator&quot;:&quot;equals&quot;,&quot;if_value&quot;:&quot;Estudiantes e inspectores de agencias regulatorias&quot;}]}],&quot;settings&quot;:{&quot;animation&quot;:&quot;yes&quot;,&quot;animation_intime&quot;:200,&quot;animation_outtime&quot;:200,&quot;conditions_ui&quot;:&quot;normal&quot;,&quot;notice_dismissed&quot;:false,&quot;repeater_remove_button&quot;:&quot;bottom&quot;}}\" \/>\n<\/fieldset>\n<div id=\"responsive-form\" class=\"clearfix\">\n\t<h2><strong>Inscripci\u00f3n en Aula Virtual 360<\/strong>\n\t<\/h2>\n\t<div class=\"form-row\">\n\t\t<h3><strong>Tipo de inscripci\u00f3n*<\/strong>\n\t\t<\/h3>\n\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"tipo-inscripcion\"><span class=\"wpcf7-form-control wpcf7-radio\"><span class=\"wpcf7-list-item first\"><label><input type=\"radio\" name=\"tipo-inscripcion\" value=\"Estudiantes e inspectores de agencias regulatorias\" \/><span class=\"wpcf7-list-item-label\">Estudiantes e inspectores de agencias regulatorias<\/span><\/label><\/span><span class=\"wpcf7-list-item last\"><label><input type=\"radio\" name=\"tipo-inscripcion\" value=\"Inscripci\u00f3n general\" \/><span class=\"wpcf7-list-item-label\">Inscripci\u00f3n general<\/span><\/label><\/span><\/span><\/span><br \/>\n<span data-id=\"grupo-tipo-inscripcion\" data-orig_data_id=\"grupo-tipo-inscripcion\" data-clear_on_hide class=\"\" data-class=\"wpcf7cf_group\"><br \/>\n<label> Por favor, sube alg\u00fan documento que te acredite como inspector o estudiante<\/label><br \/>\n<small> Se admiten archivos en formato de imagen, texto o pdf, m\u00e1x 2MB) <\/small><br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"archivo\"><input size=\"40\" class=\"wpcf7-form-control wpcf7-file wpcf7-validates-as-required\" accept=\".jpeg,.jpg,.png,.pdf,.txt\" aria-required=\"true\" aria-invalid=\"false\" type=\"file\" name=\"archivo\" \/><\/span> <\/span>\n\t\t<\/p>\n\t<\/div>\n\t<div class=\"form-row\">\n\t\t<p><label> T\u00edtulo del curso* <\/label><br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"curso\"><select class=\"wpcf7-form-control wpcf7-select wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" name=\"curso\"><option value=\"\">&#8212;Por favor, elige una opci\u00f3n&#8212;<\/option><option value=\"C1 Normas de correcta fabricaci\u00f3n (GMP) \u2013 Inicial Producci\u00f3n\">C1 Normas de correcta fabricaci\u00f3n (GMP) \u2013 Inicial Producci\u00f3n<\/option><option value=\"C2 Normas de correcta fabricaci\u00f3n (GMP) \u2013 Inicial Control de Calidad\">C2 Normas de correcta fabricaci\u00f3n (GMP) \u2013 Inicial Control de Calidad<\/option><option value=\"C3 Normas de correcta fabricaci\u00f3n (GMP) \u2013 Intermedio\">C3 Normas de correcta fabricaci\u00f3n (GMP) \u2013 Intermedio<\/option><option value=\"C4 Normas de correcta fabricaci\u00f3n (GMP) \u2013 Avanzado\">C4 Normas de correcta fabricaci\u00f3n (GMP) \u2013 Avanzado<\/option><option value=\"C5 Anexo 1 GMP Est\u00e9riles\">C5 Anexo 1 GMP Est\u00e9riles<\/option><option value=\"C6 Procesos as\u00e9pticos \u2013 Intermedio\">C6 Procesos as\u00e9pticos \u2013 Intermedio<\/option><option value=\"C7 Procesos as\u00e9pticos \u2013 Avanzado\">C7 Procesos as\u00e9pticos \u2013 Avanzado<\/option><option value=\"C8 Inspecci\u00f3n de part\u00edculas visibles \u2013 Intermedio\">C8 Inspecci\u00f3n de part\u00edculas visibles \u2013 Intermedio<\/option><option value=\"C9 Inspecci\u00f3n de part\u00edculas visibles \u2013 Avanzado\">C9 Inspecci\u00f3n de part\u00edculas visibles \u2013 Avanzado<\/option><option value=\"C10 Monitorizaci\u00f3n microbiol\u00f3gica de salas clasificadas\">C10 Monitorizaci\u00f3n microbiol\u00f3gica de salas clasificadas<\/option><option value=\"C11 Integridad de datos \u2013 Inicial\">C11 Integridad de datos \u2013 Inicial<\/option><option value=\"C12 Integridad de datos \u2013 Intermedio\">C12 Integridad de datos \u2013 Intermedio<\/option><option value=\"C13 Integridad de datos \u2013 Avanzado\">C13 Integridad de datos \u2013 Avanzado<\/option><option value=\"C14 BPL Generales \u2013 Intermedio\">C14 BPL Generales \u2013 Intermedio<\/option><option value=\"C15 BPL Generales \u2013 Avanzado\">C15 BPL Generales \u2013 Avanzado<\/option><option value=\"C16 BPL Microbiolog\u00eda - Intermedio\">C16 BPL Microbiolog\u00eda - Intermedio<\/option><option value=\"C17 BPL Microbiolog\u00eda \u2013 Avanzado\">C17 BPL Microbiolog\u00eda \u2013 Avanzado<\/option><option value=\"C18 Gesti\u00f3n de desviaciones\">C18 Gesti\u00f3n de desviaciones<\/option><option value=\"C19 Gesti\u00f3n de OOS (Out Of Specification)\">C19 Gesti\u00f3n de OOS (Out Of Specification)<\/option><option value=\"C20 Gesti\u00f3n de desviaciones de resultados microbiol\u00f3gicos \u2013 Avanzado\">C20 Gesti\u00f3n de desviaciones de resultados microbiol\u00f3gicos \u2013 Avanzado<\/option><option value=\"C21 Validaci\u00f3n de procesos\">C21 Validaci\u00f3n de procesos<\/option><option value=\"C22 Validaci\u00f3n de limpiezas \u2013 Avanzado\">C22 Validaci\u00f3n de limpiezas \u2013 Avanzado<\/option><option value=\"C23 Cualificaci\u00f3n de salas limpias\">C23 Cualificaci\u00f3n de salas limpias<\/option><option value=\"C24 Cualificaci\u00f3n de equipos\">C24 Cualificaci\u00f3n de equipos<\/option><option value=\"C25 Auditor\u00edas e inspecciones \u2013 Avanzado\">C25 Auditor\u00edas e inspecciones \u2013 Avanzado<\/option><option value=\"C26 Gesti\u00f3n de riesgos de Calidad (Quality Risk Management \u2013 ICH Q9)\u2013 Avanzado\">C26 Gesti\u00f3n de riesgos de Calidad (Quality Risk Management \u2013 ICH Q9)\u2013 Avanzado<\/option><\/select><\/span>\n\t\t<\/p>\n\t<\/div>\n\t<p><label> N\u00famero de personas que se inscriben* <\/label><br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"numero-inscritos\"><input class=\"wpcf7-form-control wpcf7-number wpcf7-validates-as-required wpcf7-validates-as-number\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Escribe un n\u00famero\" value=\"\" type=\"number\" name=\"numero-inscritos\" \/><\/span>\n\t<\/p>\n\t<h3><strong>Datos de la persona de contacto<\/strong>\n\t<\/h3>\n\t<div class=\"form-row\">\n\t\t<div class=\"column-half\">\n\t\t\t<p><label>Nombre* <span class=\"wpcf7-form-control-wrap\" data-name=\"first-name\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"first-name\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/div>\n\t\t<div class=\"column-half\">\n\t\t\t<p><label>Apellidos* <span class=\"wpcf7-form-control-wrap\" data-name=\"last-name\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"last-name\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"form-row\">\n\t\t<div class=\"column-half\">\n\t\t\t<p><label>Cargo* <span class=\"wpcf7-form-control-wrap\" data-name=\"cargo\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"cargo\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/div>\n\t\t<div class=\"column-half\">\n\t\t\t<p><label>Tel\u00e9fono <span class=\"wpcf7-form-control-wrap\" data-name=\"telefono\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-tel wpcf7-text wpcf7-validates-as-tel\" aria-invalid=\"false\" value=\"\" type=\"tel\" name=\"telefono\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"form-row\">\n\t\t<div class=\"column-half\">\n\t\t\t<p><label>Correo electr\u00f3nico* <span class=\"wpcf7-form-control-wrap\" data-name=\"your-email\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-email wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-email\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"email\" name=\"your-email\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/div>\n\t\t<div class=\"column-half\">\n\t\t\t<p><label>Repetir correo* <span class=\"wpcf7-form-control-wrap\" data-name=\"your-email-confirm\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-email wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-email\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"email\" name=\"your-email-confirm\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<h3><strong>Datos fiscales de la empresa<\/strong>\n\t<\/h3>\n\t<div class=\"form-row\">\n\t\t<div class=\"column-half\">\n\t\t\t<p><label>Raz\u00f3n social* <span class=\"wpcf7-form-control-wrap\" data-name=\"empresa\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"empresa\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/div>\n\t\t<div class=\"column-half\">\n\t\t\t<p><label>NIF\/CIF* <span class=\"wpcf7-form-control-wrap\" data-name=\"cif\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"cif\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"form-row\">\n\t\t<p><label>Direcci\u00f3n fiscal completa* <span class=\"wpcf7-form-control-wrap\" data-name=\"direccion\"><textarea cols=\"40\" rows=\"10\" maxlength=\"2000\" class=\"wpcf7-form-control wpcf7-textarea wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" name=\"direccion\"><\/textarea><\/span><\/label>\n\t\t<\/p>\n\t<\/div>\n\t<div class=\"form-row\">\n\t\t<div class=\"column-half\">\n\t\t\t<p><label>N\u00ba de pedido interno <span class=\"wpcf7-form-control-wrap\" data-name=\"numero-pedido-interno\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"numero-pedido-interno\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/div>\n\t\t<div class=\"column-half\">\n\t\t\t<p><label>Tel\u00e9fono facturaci\u00f3n* <span class=\"wpcf7-form-control-wrap\" data-name=\"telefono-facturacion\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-tel wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-tel\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"tel\" name=\"telefono-facturacion\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"form-row\">\n\t\t<div class=\"column-half\">\n\t\t\t<p><label>Email para env\u00edo factura* <span class=\"wpcf7-form-control-wrap\" data-name=\"email-factura\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-email wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-email\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"email\" name=\"email-factura\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/div>\n\t\t<div class=\"column-half\">\n\t\t\t<p><label>Repetir email* <span class=\"wpcf7-form-control-wrap\" data-name=\"email-factura-confirm\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-email wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-email\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"email\" name=\"email-factura-confirm\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"form-row\">\n\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"acceptance-65\"><span class=\"wpcf7-form-control wpcf7-acceptance\"><span class=\"wpcf7-list-item\"><input type=\"checkbox\" name=\"acceptance-65\" value=\"1\" aria-invalid=\"false\" \/><\/span><\/span><\/span> He le\u00eddo y acepto los <a target=\"_blank\" href=\"https:\/\/www.asinfarma.com\/aviso-legal\/\">t\u00e9rminos y condiciones<\/a>\n\t\t<\/p>\n\t<\/div>\n\t<div class=\"form-row\">\n\t\t<p><input class=\"wpcf7-form-control wpcf7-submit has-spinner\" type=\"submit\" value=\"Enviar\" \/>\n\t\t<\/p>\n\t<\/div>\n\t<div class=\"form-row\" style=\"text-align:left;\">\n\t\t<p><small>*Campos obligatorios<\/small>\n\t\t<\/p>\n\t<\/div>\n<\/div><p style=\"display: none !important;\" class=\"akismet-fields-container\" data-prefix=\"_wpcf7_ak_\"><label>&#916;<textarea name=\"_wpcf7_ak_hp_textarea\" cols=\"45\" rows=\"8\" maxlength=\"100\"><\/textarea><\/label><input type=\"hidden\" id=\"ak_js_1\" name=\"_wpcf7_ak_js\" value=\"156\"\/><script>\ndocument.getElementById( \"ak_js_1\" ).setAttribute( \"value\", ( new Date() ).getTime() );\n<\/script>\n<\/p><div class=\"wpcf7-response-output\" aria-hidden=\"true\"><\/div>\n<\/form>\n<\/div>\n<\/div>\n\n\n<\/div>\n\n\n\n<div class=\"wp-block-group has-global-color-13-background-color has-background\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<p style=\"text-transform:uppercase\"><strong>Objetivos del curso<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>Comprender a fondo los requisitos del Anexo 1 y su evoluci\u00f3n para asegurar el cumplimiento en la fabricaci\u00f3n de medicamentos est\u00e9riles.<\/li>\n\n\n\n<li>Capacitar en la implementaci\u00f3n de estrategias pr\u00e1cticas de control de la contaminaci\u00f3n, monitorizaci\u00f3n ambiental y dise\u00f1o de procesos est\u00e9riles.<\/li>\n\n\n\n<li>Aplicar criterios t\u00e9cnicos y regulatorios en la evaluaci\u00f3n, cualificaci\u00f3n y operaci\u00f3n de instalaciones, equipos, personal y servicios cr\u00edticos.<\/li>\n<\/ol>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<p style=\"text-transform:uppercase\"><strong>P\u00fablico objetivo<\/strong><\/p>\n\n\n\n<p>T\u00e9cnicos\/as y responsables de&nbsp;producci\u00f3n, calidad, validaciones, ingenier\u00eda y microbiolog\u00eda&nbsp;en plantas de fabricaci\u00f3n de est\u00e9riles.<\/p>\n\n\n\n<p>Profesionales implicados en el dise\u00f1o, cualificaci\u00f3n y operaci\u00f3n de \u00e1reas limpias, tecnolog\u00edas de barrera, APS y procesos cr\u00edticos.<\/p>\n<\/div>\n<\/div>\n<\/div><\/div>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading alignfull has-text-align-left has-base-3-color has-global-color-10-background-color has-text-color has-background has-link-color wp-elements-c42a9bee9613217b8acfa410a02f8381\"><strong>Programa detallado de contenidos<\/strong> <br>C5 Anexo 1 GMP Est\u00e9riles<\/h2>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-group has-base-2-background-color has-background\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<h3 class=\"wp-block-heading\"><strong>M\u00d3DULO 1: Introducci\u00f3n al Anexo 1 y su evoluci\u00f3n<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Historia del Anexo 1 desde<\/li>\n\n\n\n<li>Motivos de la \u00faltima revisi\u00f3n<\/li>\n\n\n\n<li>Reestructuraci\u00f3n del documento<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>M\u00d3DULO 2: Principios Generales y Gesti\u00f3n de Riesgos<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Alcance del Anexo 1<\/li>\n\n\n\n<li>Principios aplicables a todos los productos est\u00e9riles<\/li>\n\n\n\n<li>Implementaci\u00f3n de la Gesti\u00f3n de Riesgos de Calidad (QRM)<\/li>\n\n\n\n<li>Estrategia de control de la contaminaci\u00f3n (CCS)<\/li>\n\n\n\n<li>Rol de los equipos multidisciplinares<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>M\u00d3DULO 3: Sistema de Calidad Farmac\u00e9utica<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Requisitos del sistema de calidad para est\u00e9riles<\/li>\n\n\n\n<li>Integraci\u00f3n del QRM en el ciclo de vida<\/li>\n\n\n\n<li>Gesti\u00f3n de desviaciones y CAPAs<\/li>\n\n\n\n<li>Evaluaci\u00f3n de riesgos documentada<\/li>\n\n\n\n<li>Revisi\u00f3n por la direcci\u00f3n y control de cambios<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>M\u00d3DULO 4: Instalaciones, Locales y Dise\u00f1o de \u00c1reas Limpias<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Dise\u00f1o y materiales de construcci\u00f3n<\/li>\n\n\n\n<li>Sistemas de barrera\n<ul class=\"wp-block-list\">\n<li><em>Restricted Access Barrier Systems<\/em> (RABS)<\/li>\n\n\n\n<li>Aisladores<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Clasificaci\u00f3n de \u00e1reas limpias (A, B, C, D)<\/li>\n\n\n\n<li>Transferencias en zonas as\u00e9pticas\n<ul class=\"wp-block-list\">\n<li>Esclusas de personal<\/li>\n\n\n\n<li>Esclusas de material<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Diferenciales de presi\u00f3n y flujo de aire<\/li>\n\n\n\n<li>Estudios de humos (visualizaci\u00f3n del flujo)<\/li>\n\n\n\n<li>Alarmas<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>M\u00d3DULO 5: Tecnolog\u00edas de Barrera: RABS y Aisladores<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Requisitos de RABS\n<ul class=\"wp-block-list\">\n<li>Dise\u00f1o<\/li>\n\n\n\n<li>Gesti\u00f3n de guantes<\/li>\n\n\n\n<li>Ciclos de biodescontaminaci\u00f3n<\/li>\n\n\n\n<li>Entorno<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Requisitos de aisladores\n<ul class=\"wp-block-list\">\n<li>Dise\u00f1o<\/li>\n\n\n\n<li>Gesti\u00f3n de guantes<\/li>\n\n\n\n<li>Ciclo de biodescontaminaci\u00f3n<\/li>\n\n\n\n<li>Entorno<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Entradas y salidas de materiales est\u00e9riles<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>M\u00d3DULO 6: Cualificaci\u00f3n de salas y desinfecci\u00f3n<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Principios generales<\/li>\n\n\n\n<li>Cualificaci\u00f3n de salas limpias: Test de cualificaci\u00f3n\n<ul class=\"wp-block-list\">\n<li>Clasificaci\u00f3n de salas limpias<\/li>\n\n\n\n<li>ISO 14644: Concentraci\u00f3n de part\u00edculas permitidas en el aire<\/li>\n\n\n\n<li>Condiciones in operation y at rest<\/li>\n\n\n\n<li>Concentraci\u00f3n microbiana<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Recualificaci\u00f3n de salas<\/li>\n\n\n\n<li>Desinfecci\u00f3n de instalaciones\n<ul class=\"wp-block-list\">\n<li>Programa de desinfecci\u00f3n<\/li>\n\n\n\n<li>Requisitos previos: limpieza<\/li>\n\n\n\n<li>Desinfectantes<\/li>\n\n\n\n<li>Fumigaci\u00f3n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>M\u00d3DULO 7: Equipos<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Consideraciones relevantes<\/li>\n\n\n\n<li>Dise\u00f1os y limpieza<\/li>\n\n\n\n<li>Cualificaci\u00f3n y validaci\u00f3n<\/li>\n\n\n\n<li>Mantenimiento y mantenimiento no planificado<\/li>\n\n\n\n<li>Componentes cr\u00edticos<\/li>\n\n\n\n<li>Contadores de part\u00edculas<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>M\u00d3DULO 8: Servicios<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Riesgos de los servicios<\/li>\n\n\n\n<li>Dise\u00f1o y control<\/li>\n\n\n\n<li>Sistemas de aguas\n<ul class=\"wp-block-list\">\n<li>Puntos cr\u00edticos<\/li>\n\n\n\n<li>Filtros<\/li>\n\n\n\n<li>Calidad del agua<\/li>\n\n\n\n<li>Agua para inyecci\u00f3n (WFI)<\/li>\n\n\n\n<li>Filtros de venteo<\/li>\n\n\n\n<li>Control microbiol\u00f3gico<\/li>\n\n\n\n<li>Desinfecci\u00f3n<\/li>\n\n\n\n<li>Programa de muestreo<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Vapor utilizado para esterilizaci\u00f3n\n<ul class=\"wp-block-list\">\n<li>Puntos cr\u00edticos<\/li>\n\n\n\n<li>Par\u00e1metros<\/li>\n\n\n\n<li>Calidad<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Gases y sistemas de vac\u00edo\n<ul class=\"wp-block-list\">\n<li>Filtros y components<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Sistemas de calefacci\u00f3n, enfriamiento e hidr\u00e1ulicos<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>M\u00d3DULO 9: Personal<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Requisitos de cualificaci\u00f3n, formaci\u00f3n y evaluaci\u00f3n continua<\/li>\n\n\n\n<li>Control de accesos a grado A\/B<\/li>\n\n\n\n<li>Higiene<\/li>\n\n\n\n<li>Normas de vestimenta seg\u00fan el grado\n<ul class=\"wp-block-list\">\n<li>Grado A<\/li>\n\n\n\n<li>Grado B<\/li>\n\n\n\n<li>Grado C<\/li>\n\n\n\n<li>Grado D<\/li>\n\n\n\n<li>Cualificaci\u00f3n del vestuario<\/li>\n\n\n\n<li>Lavado de la ropa<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Comportamiento adecuado y t\u00e9cnicas as\u00e9pticas<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>M\u00d3DULO 10: Producci\u00f3n y Tecnolog\u00edas Espec\u00edficas<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Esterilizaci\u00f3n terminal\n<ul class=\"wp-block-list\">\n<li>Actividades<\/li>\n\n\n\n<li>Grados<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Procesos y preparaci\u00f3n as\u00e9pticas\n<ul class=\"wp-block-list\">\n<li>Control de la contaminaci\u00f3n<\/li>\n\n\n\n<li>Uso de tecnolog\u00eda de barrera<\/li>\n\n\n\n<li>Actividades y grados<\/li>\n\n\n\n<li>Intervenciones<\/li>\n\n\n\n<li>Holding times<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Acabado de productos est\u00e9riles\n<ul class=\"wp-block-list\">\n<li>Cierres<\/li>\n\n\n\n<li>Test de integridad<\/li>\n\n\n\n<li>Capsulado<\/li>\n\n\n\n<li>Inspecci\u00f3n visual<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>M\u00d3DULO 11: Esterilizaci\u00f3n<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Esterilizaci\u00f3n de producto\n<ul class=\"wp-block-list\">\n<li>Elecci\u00f3n del m\u00e9todo<\/li>\n\n\n\n<li>Cargas a validar<\/li>\n\n\n\n<li>Par\u00e1metros de validaci\u00f3n<\/li>\n\n\n\n<li>Indicadores biol\u00f3gicos<\/li>\n\n\n\n<li>Control de productos esterilizados<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Materiales y componentes\n<ul class=\"wp-block-list\">\n<li>Consideraciones importantes<\/li>\n\n\n\n<li>Transferencia de material est\u00e9ril<\/li>\n\n\n\n<li>Validaci\u00f3n de transferencia y del material de empaque<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>M\u00e9todos de esterilizaci\u00f3n\n<ul class=\"wp-block-list\">\n<li>Generalidades<\/li>\n\n\n\n<li>Esterilizaci\u00f3n por calor\n<ul class=\"wp-block-list\">\n<li>Carlos h\u00famedo<\/li>\n\n\n\n<li>Calor seco<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Esterilizaci\u00f3n por radiaci\u00f3n<\/li>\n\n\n\n<li>Esterilizaci\u00f3n por \u00f3xido de etileno<\/li>\n\n\n\n<li>Esterilizaci\u00f3n por filtraci\u00f3n\n<ul class=\"wp-block-list\">\n<li>Filtros<\/li>\n\n\n\n<li>Dise\u00f1o del sistema de filtraci\u00f3n<\/li>\n\n\n\n<li>Validaci\u00f3n de filtraci\u00f3n<\/li>\n\n\n\n<li>Integridad de filtros (PUPSIT)<\/li>\n\n\n\n<li>Filtros de gases<\/li>\n\n\n\n<li>Bioburden<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>M\u00d3DULO 12: Liofilizaci\u00f3n<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Dise\u00f1o del proceso<\/li>\n\n\n\n<li>Puntos cr\u00edticos<\/li>\n\n\n\n<li>Esterilizaci\u00f3n<\/li>\n\n\n\n<li>Test de fugas<\/li>\n\n\n\n<li>Carga y descarga<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>M\u00d3DULO 13: Sistemas cerrados y de un solo uso<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Dise\u00f1o de sistemas cerrados<\/li>\n\n\n\n<li>Conexiones as\u00e9pticas<\/li>\n\n\n\n<li>Entornos<\/li>\n\n\n\n<li><em>Single Use Systems<\/em> (SUS)\n<ul class=\"wp-block-list\">\n<li>Riesgos<\/li>\n\n\n\n<li>Esterilizaci\u00f3n<\/li>\n\n\n\n<li>Evaluaci\u00f3n de proveedores<\/li>\n\n\n\n<li>Compatibilidad de materiales (extra\u00edbles)<\/li>\n\n\n\n<li>Aceptaci\u00f3n de los SUS<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>M\u00d3DULO 14: Monitorizaci\u00f3n ambiental<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Generalidades de part\u00edculas viables y part\u00edculas totales<\/li>\n\n\n\n<li>Programa de monitorizaci\u00f3n<\/li>\n\n\n\n<li>Monitorizaci\u00f3n ambiental\n<ul class=\"wp-block-list\">\n<li>An\u00e1lisis de riesgos<\/li>\n\n\n\n<li>L\u00edmites de alerta y de acci\u00f3n<\/li>\n\n\n\n<li>Evaluaci\u00f3n de tendencias<\/li>\n\n\n\n<li>Resultados fuera de l\u00edmites<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Monitorizaci\u00f3n de part\u00edculas totales\n<ul class=\"wp-block-list\">\n<li>Objetivos<\/li>\n\n\n\n<li>L\u00edmites<\/li>\n\n\n\n<li>Recuentos ocasionales<\/li>\n\n\n\n<li>Consideraciones en grado A y B<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Monitorizaci\u00f3n ambiental y personal \u2013 part\u00edculas viables\n<ul class=\"wp-block-list\">\n<li>Operaciones as\u00e9pticas<\/li>\n\n\n\n<li>Salas sin operaciones<\/li>\n\n\n\n<li>Frecuencia de monitorizaci\u00f3n<\/li>\n\n\n\n<li>An\u00e1lisis de riesgos \u2013 personal<\/li>\n\n\n\n<li>L\u00edmites de acci\u00f3n<\/li>\n\n\n\n<li>Identificaciones microbianas<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>M\u00d3DULO 15: <em>Aseptic Process Simulation<\/em> (APS)<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Procesos as\u00e9pticos<\/li>\n\n\n\n<li>Generalidades<\/li>\n\n\n\n<li>Intervenciones<\/li>\n\n\n\n<li>Dise\u00f1o de la estrategia<\/li>\n\n\n\n<li>Frecuencia<ul><li>Validaci\u00f3n inicial<\/li><\/ul>\n<ul class=\"wp-block-list\">\n<li>Revalidaci\u00f3n<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Unidades envasadas<\/li>\n\n\n\n<li>Inspecci\u00f3n de las unidades<\/li>\n\n\n\n<li>Incubaci\u00f3n<\/li>\n\n\n\n<li>Resultados<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>M\u00d3DULO 16: Control de Calidad<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Personal responsable<\/li>\n\n\n\n<li>Especificaciones<\/li>\n\n\n\n<li>Ensayo de bioburden<\/li>\n\n\n\n<li>Test de esterilidad<\/li>\n\n\n\n<li>Growth Promotion Test<\/li>\n\n\n\n<li>Resultados microbiol\u00f3gicos<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n<span class=\"su-lightbox\" data-mfp-src=\"#formulario-inscripcion\" data-mfp-type=\"inline\" data-mobile=\"yes\">\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-16018d1d wp-block-buttons-is-layout-flex\">\n<div 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action=\"\/aulavirtual360\/wp-json\/wp\/v2\/posts\/302#wpcf7-f359-o2\" method=\"post\" class=\"wpcf7-form init\" aria-label=\"Formulario de contacto\" enctype=\"multipart\/form-data\" novalidate=\"novalidate\" data-status=\"init\">\n<fieldset class=\"hidden-fields-container\"><input type=\"hidden\" name=\"_wpcf7\" value=\"359\" \/><input type=\"hidden\" name=\"_wpcf7_version\" value=\"6.1.6\" \/><input type=\"hidden\" name=\"_wpcf7_locale\" value=\"es_ES\" \/><input type=\"hidden\" name=\"_wpcf7_unit_tag\" value=\"wpcf7-f359-o2\" \/><input type=\"hidden\" name=\"_wpcf7_container_post\" value=\"0\" \/><input type=\"hidden\" name=\"_wpcf7_posted_data_hash\" value=\"\" \/><input type=\"hidden\" name=\"_wpcf7cf_hidden_group_fields\" value=\"[]\" \/><input type=\"hidden\" name=\"_wpcf7cf_hidden_groups\" value=\"[]\" \/><input type=\"hidden\" name=\"_wpcf7cf_visible_groups\" value=\"[]\" \/><input type=\"hidden\" name=\"_wpcf7cf_repeaters\" value=\"[]\" \/><input type=\"hidden\" name=\"_wpcf7cf_steps\" value=\"{}\" \/><input type=\"hidden\" name=\"_wpcf7cf_options\" value=\"{&quot;form_id&quot;:359,&quot;conditions&quot;:[{&quot;then_field&quot;:&quot;grupo-tipo-inscripcion&quot;,&quot;and_rules&quot;:[{&quot;if_field&quot;:&quot;tipo-inscripcion&quot;,&quot;operator&quot;:&quot;equals&quot;,&quot;if_value&quot;:&quot;Estudiantes e inspectores de agencias regulatorias&quot;}]}],&quot;settings&quot;:{&quot;animation&quot;:&quot;yes&quot;,&quot;animation_intime&quot;:200,&quot;animation_outtime&quot;:200,&quot;conditions_ui&quot;:&quot;normal&quot;,&quot;notice_dismissed&quot;:false,&quot;repeater_remove_button&quot;:&quot;bottom&quot;}}\" \/>\n<\/fieldset>\n<div id=\"responsive-form\" class=\"clearfix\">\n\t<h2><strong>Inscripci\u00f3n en Aula Virtual 360<\/strong>\n\t<\/h2>\n\t<div class=\"form-row\">\n\t\t<h3><strong>Tipo de inscripci\u00f3n*<\/strong>\n\t\t<\/h3>\n\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"tipo-inscripcion\"><span class=\"wpcf7-form-control wpcf7-radio\"><span class=\"wpcf7-list-item first\"><label><input type=\"radio\" name=\"tipo-inscripcion\" value=\"Estudiantes e inspectores de agencias regulatorias\" \/><span class=\"wpcf7-list-item-label\">Estudiantes e inspectores de agencias regulatorias<\/span><\/label><\/span><span class=\"wpcf7-list-item last\"><label><input type=\"radio\" name=\"tipo-inscripcion\" value=\"Inscripci\u00f3n general\" \/><span class=\"wpcf7-list-item-label\">Inscripci\u00f3n general<\/span><\/label><\/span><\/span><\/span><br \/>\n<span data-id=\"grupo-tipo-inscripcion\" data-orig_data_id=\"grupo-tipo-inscripcion\" data-clear_on_hide class=\"\" data-class=\"wpcf7cf_group\"><br \/>\n<label> Por favor, sube alg\u00fan documento que te acredite como inspector o estudiante<\/label><br \/>\n<small> Se admiten archivos en formato de imagen, texto o pdf, m\u00e1x 2MB) <\/small><br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"archivo\"><input size=\"40\" class=\"wpcf7-form-control wpcf7-file wpcf7-validates-as-required\" accept=\".jpeg,.jpg,.png,.pdf,.txt\" aria-required=\"true\" aria-invalid=\"false\" type=\"file\" name=\"archivo\" \/><\/span> <\/span>\n\t\t<\/p>\n\t<\/div>\n\t<div class=\"form-row\">\n\t\t<p><label> T\u00edtulo del curso* <\/label><br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"curso\"><select class=\"wpcf7-form-control wpcf7-select wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" name=\"curso\"><option value=\"\">&#8212;Por favor, elige una opci\u00f3n&#8212;<\/option><option value=\"C1 Normas de correcta fabricaci\u00f3n (GMP) \u2013 Inicial Producci\u00f3n\">C1 Normas de correcta fabricaci\u00f3n (GMP) \u2013 Inicial Producci\u00f3n<\/option><option value=\"C2 Normas de correcta fabricaci\u00f3n (GMP) \u2013 Inicial Control de Calidad\">C2 Normas de correcta fabricaci\u00f3n (GMP) \u2013 Inicial Control de Calidad<\/option><option value=\"C3 Normas de correcta fabricaci\u00f3n (GMP) \u2013 Intermedio\">C3 Normas de correcta fabricaci\u00f3n (GMP) \u2013 Intermedio<\/option><option value=\"C4 Normas de correcta fabricaci\u00f3n (GMP) \u2013 Avanzado\">C4 Normas de correcta fabricaci\u00f3n (GMP) \u2013 Avanzado<\/option><option value=\"C5 Anexo 1 GMP Est\u00e9riles\">C5 Anexo 1 GMP Est\u00e9riles<\/option><option value=\"C6 Procesos as\u00e9pticos \u2013 Intermedio\">C6 Procesos as\u00e9pticos \u2013 Intermedio<\/option><option value=\"C7 Procesos as\u00e9pticos \u2013 Avanzado\">C7 Procesos as\u00e9pticos \u2013 Avanzado<\/option><option value=\"C8 Inspecci\u00f3n de part\u00edculas visibles \u2013 Intermedio\">C8 Inspecci\u00f3n de part\u00edculas visibles \u2013 Intermedio<\/option><option value=\"C9 Inspecci\u00f3n de part\u00edculas visibles \u2013 Avanzado\">C9 Inspecci\u00f3n de part\u00edculas visibles \u2013 Avanzado<\/option><option value=\"C10 Monitorizaci\u00f3n microbiol\u00f3gica de salas clasificadas\">C10 Monitorizaci\u00f3n microbiol\u00f3gica de salas clasificadas<\/option><option value=\"C11 Integridad de datos \u2013 Inicial\">C11 Integridad de datos \u2013 Inicial<\/option><option value=\"C12 Integridad de datos \u2013 Intermedio\">C12 Integridad de datos \u2013 Intermedio<\/option><option value=\"C13 Integridad de datos \u2013 Avanzado\">C13 Integridad de datos \u2013 Avanzado<\/option><option value=\"C14 BPL Generales \u2013 Intermedio\">C14 BPL Generales \u2013 Intermedio<\/option><option value=\"C15 BPL Generales \u2013 Avanzado\">C15 BPL Generales \u2013 Avanzado<\/option><option value=\"C16 BPL Microbiolog\u00eda - Intermedio\">C16 BPL Microbiolog\u00eda - Intermedio<\/option><option value=\"C17 BPL Microbiolog\u00eda \u2013 Avanzado\">C17 BPL Microbiolog\u00eda \u2013 Avanzado<\/option><option value=\"C18 Gesti\u00f3n de desviaciones\">C18 Gesti\u00f3n de desviaciones<\/option><option value=\"C19 Gesti\u00f3n de OOS (Out Of Specification)\">C19 Gesti\u00f3n de OOS (Out Of Specification)<\/option><option value=\"C20 Gesti\u00f3n de desviaciones de resultados microbiol\u00f3gicos \u2013 Avanzado\">C20 Gesti\u00f3n de desviaciones de resultados microbiol\u00f3gicos \u2013 Avanzado<\/option><option value=\"C21 Validaci\u00f3n de procesos\">C21 Validaci\u00f3n de procesos<\/option><option value=\"C22 Validaci\u00f3n de limpiezas \u2013 Avanzado\">C22 Validaci\u00f3n de limpiezas \u2013 Avanzado<\/option><option value=\"C23 Cualificaci\u00f3n de salas limpias\">C23 Cualificaci\u00f3n de salas limpias<\/option><option value=\"C24 Cualificaci\u00f3n de equipos\">C24 Cualificaci\u00f3n de equipos<\/option><option value=\"C25 Auditor\u00edas e inspecciones \u2013 Avanzado\">C25 Auditor\u00edas e inspecciones \u2013 Avanzado<\/option><option value=\"C26 Gesti\u00f3n de riesgos de Calidad (Quality Risk Management \u2013 ICH Q9)\u2013 Avanzado\">C26 Gesti\u00f3n de riesgos de Calidad (Quality Risk Management \u2013 ICH Q9)\u2013 Avanzado<\/option><\/select><\/span>\n\t\t<\/p>\n\t<\/div>\n\t<p><label> N\u00famero de personas que se inscriben* <\/label><br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"numero-inscritos\"><input class=\"wpcf7-form-control wpcf7-number wpcf7-validates-as-required wpcf7-validates-as-number\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Escribe un n\u00famero\" value=\"\" type=\"number\" name=\"numero-inscritos\" \/><\/span>\n\t<\/p>\n\t<h3><strong>Datos de la persona de contacto<\/strong>\n\t<\/h3>\n\t<div class=\"form-row\">\n\t\t<div class=\"column-half\">\n\t\t\t<p><label>Nombre* <span class=\"wpcf7-form-control-wrap\" data-name=\"first-name\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"first-name\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/div>\n\t\t<div class=\"column-half\">\n\t\t\t<p><label>Apellidos* <span class=\"wpcf7-form-control-wrap\" data-name=\"last-name\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"last-name\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"form-row\">\n\t\t<div class=\"column-half\">\n\t\t\t<p><label>Cargo* <span class=\"wpcf7-form-control-wrap\" data-name=\"cargo\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"cargo\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/div>\n\t\t<div class=\"column-half\">\n\t\t\t<p><label>Tel\u00e9fono <span class=\"wpcf7-form-control-wrap\" data-name=\"telefono\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-tel wpcf7-text wpcf7-validates-as-tel\" aria-invalid=\"false\" value=\"\" type=\"tel\" name=\"telefono\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"form-row\">\n\t\t<div class=\"column-half\">\n\t\t\t<p><label>Correo electr\u00f3nico* <span class=\"wpcf7-form-control-wrap\" data-name=\"your-email\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-email wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-email\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"email\" name=\"your-email\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/div>\n\t\t<div class=\"column-half\">\n\t\t\t<p><label>Repetir correo* <span class=\"wpcf7-form-control-wrap\" data-name=\"your-email-confirm\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-email wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-email\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"email\" name=\"your-email-confirm\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<h3><strong>Datos fiscales de la empresa<\/strong>\n\t<\/h3>\n\t<div class=\"form-row\">\n\t\t<div class=\"column-half\">\n\t\t\t<p><label>Raz\u00f3n social* <span class=\"wpcf7-form-control-wrap\" data-name=\"empresa\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"empresa\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/div>\n\t\t<div class=\"column-half\">\n\t\t\t<p><label>NIF\/CIF* <span class=\"wpcf7-form-control-wrap\" data-name=\"cif\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"cif\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"form-row\">\n\t\t<p><label>Direcci\u00f3n fiscal completa* <span class=\"wpcf7-form-control-wrap\" data-name=\"direccion\"><textarea cols=\"40\" rows=\"10\" maxlength=\"2000\" class=\"wpcf7-form-control wpcf7-textarea wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" name=\"direccion\"><\/textarea><\/span><\/label>\n\t\t<\/p>\n\t<\/div>\n\t<div class=\"form-row\">\n\t\t<div class=\"column-half\">\n\t\t\t<p><label>N\u00ba de pedido interno <span class=\"wpcf7-form-control-wrap\" data-name=\"numero-pedido-interno\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"numero-pedido-interno\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/div>\n\t\t<div class=\"column-half\">\n\t\t\t<p><label>Tel\u00e9fono facturaci\u00f3n* <span class=\"wpcf7-form-control-wrap\" data-name=\"telefono-facturacion\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-tel wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-tel\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"tel\" name=\"telefono-facturacion\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"form-row\">\n\t\t<div class=\"column-half\">\n\t\t\t<p><label>Email para env\u00edo factura* <span class=\"wpcf7-form-control-wrap\" data-name=\"email-factura\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-email wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-email\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"email\" name=\"email-factura\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/div>\n\t\t<div class=\"column-half\">\n\t\t\t<p><label>Repetir email* <span class=\"wpcf7-form-control-wrap\" data-name=\"email-factura-confirm\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-email wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-email\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"email\" name=\"email-factura-confirm\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"form-row\">\n\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"acceptance-65\"><span class=\"wpcf7-form-control wpcf7-acceptance\"><span class=\"wpcf7-list-item\"><input type=\"checkbox\" name=\"acceptance-65\" value=\"1\" aria-invalid=\"false\" \/><\/span><\/span><\/span> He le\u00eddo y acepto los <a target=\"_blank\" href=\"https:\/\/www.asinfarma.com\/aviso-legal\/\">t\u00e9rminos y condiciones<\/a>\n\t\t<\/p>\n\t<\/div>\n\t<div class=\"form-row\">\n\t\t<p><input class=\"wpcf7-form-control wpcf7-submit has-spinner\" type=\"submit\" value=\"Enviar\" \/>\n\t\t<\/p>\n\t<\/div>\n\t<div class=\"form-row\" style=\"text-align:left;\">\n\t\t<p><small>*Campos obligatorios<\/small>\n\t\t<\/p>\n\t<\/div>\n<\/div><p style=\"display: none !important;\" class=\"akismet-fields-container\" data-prefix=\"_wpcf7_ak_\"><label>&#916;<textarea name=\"_wpcf7_ak_hp_textarea\" cols=\"45\" rows=\"8\" maxlength=\"100\"><\/textarea><\/label><input type=\"hidden\" id=\"ak_js_2\" name=\"_wpcf7_ak_js\" value=\"41\"\/><script>\ndocument.getElementById( \"ak_js_2\" ).setAttribute( \"value\", ( new Date() ).getTime() );\n<\/script>\n<\/p><div class=\"wpcf7-response-output\" aria-hidden=\"true\"><\/div>\n<\/form>\n<\/div>\n<\/div>\n\n\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>INFORMACI\u00d3N ORGANIZATIVA DESCRIPCI\u00d3N DEL CURSO Objetivos del curso P\u00fablico objetivo T\u00e9cnicos\/as y responsables de&nbsp;producci\u00f3n, calidad, validaciones, ingenier\u00eda y microbiolog\u00eda&nbsp;en plantas de fabricaci\u00f3n de est\u00e9riles. Profesionales implicados en el dise\u00f1o, cualificaci\u00f3n y operaci\u00f3n de \u00e1reas limpias, tecnolog\u00edas de barrera, APS y procesos cr\u00edticos. Programa detallado de contenidos C5 Anexo 1 GMP Est\u00e9riles M\u00d3DULO 1: Introducci\u00f3n al &#8230; <a title=\"Anexo 1 GMP Est\u00e9riles\" class=\"read-more\" href=\"https:\/\/www.asinfarma.com\/aulavirtual360\/anexo-1-gmp-esteriles\/\" aria-label=\"Leer m\u00e1s sobre Anexo 1 GMP Est\u00e9riles\">Leer m\u00e1s<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-302","post","type-post","status-publish","format-standard","hentry","category-sin-categoria","generate-columns","tablet-grid-50","mobile-grid-100","grid-parent","grid-50"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Anexo 1 GMP Est\u00e9riles - Aula virtual 360 Asinfarma<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.asinfarma.com\/aulavirtual360\/anexo-1-gmp-esteriles\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Anexo 1 GMP Est\u00e9riles - Aula virtual 360 Asinfarma\" \/>\n<meta property=\"og:description\" content=\"INFORMACI\u00d3N ORGANIZATIVA DESCRIPCI\u00d3N DEL CURSO Objetivos del curso P\u00fablico objetivo T\u00e9cnicos\/as y responsables de&nbsp;producci\u00f3n, calidad, validaciones, ingenier\u00eda y microbiolog\u00eda&nbsp;en plantas de fabricaci\u00f3n de est\u00e9riles. Profesionales implicados en el dise\u00f1o, cualificaci\u00f3n y operaci\u00f3n de \u00e1reas limpias, tecnolog\u00edas de barrera, APS y procesos cr\u00edticos. Programa detallado de contenidos C5 Anexo 1 GMP Est\u00e9riles M\u00d3DULO 1: Introducci\u00f3n al ... 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