{"id":4054,"date":"2024-03-12T07:40:01","date_gmt":"2024-03-12T07:40:01","guid":{"rendered":"https:\/\/mycetoma.edu.sd\/?page_id=4054"},"modified":"2024-04-27T16:00:31","modified_gmt":"2024-04-27T16:00:31","slug":"good-clinical-laboratory-practice-gclp","status":"publish","type":"page","link":"https:\/\/mycetoma.edu.sd\/?page_id=4054","title":{"rendered":"Good Clinical Laboratory Practice (GCLP)"},"content":{"rendered":"<p style=\"text-align: justify;\"><strong>he Mycetoma Research Centre<\/strong><\/p>\n<p style=\"text-align: justify;\"><strong>University of Khartoum<\/strong><\/p>\n<p style=\"text-align: justify;\"><strong>WHO Collaborating Centre on Mycetoma<\/strong><\/p>\n<p style=\"text-align: justify;\"><strong>\u00a0The Mycetoma Research and Development Arcade<\/strong><\/p>\n<p class=\"greenfill\" style=\"text-align: justify;\"><strong>Workshop Overview<\/strong><\/p>\n<p style=\"text-align: justify;\">Good clinical laboratory practice (GCLP) workshop provides and discusses the quality system principles and procedures that the clinical laboratories should carry out to provide consistent, reproducible, reliable laboratory results. This workshop will offer unique, comprehensive guidance on implementing GCLP in the laboratories.<\/p>\n<p class=\"greenfill\" style=\"text-align: justify;\"><strong>Workshop Facilitators<\/strong><\/p>\n<p style=\"text-align: justify;\">A group of experts will facilitate the workshop.<\/p>\n<p class=\"greenfill\" style=\"text-align: justify;\"><strong>Learning Objectives<\/strong><\/p>\n<p style=\"text-align: justify;\">By the end of the course, participants will have a good understanding of:<\/p>\n<ul style=\"text-align: justify;\">\n<li data-mce-word-list=\"1\">What is a GCLP<\/li>\n<li data-mce-word-list=\"1\">What are the GCLP principles and the requirements of each one<\/li>\n<li data-mce-word-list=\"1\">Identify how GCLP compliance benefits laboratories<\/li>\n<li data-mce-word-list=\"1\">Identify how GCLP is implemented across the whole clinical trial process<\/li>\n<li data-mce-word-list=\"1\">Laboratory management; facilities, organization and personnel<\/li>\n<li data-mce-word-list=\"1\">Scientific analysis, reporting and archiving<\/li>\n<li data-mce-word-list=\"1\">What are the Standard Operation procedures and their importance<\/li>\n<li data-mce-word-list=\"1\">Laboratory quality assurance<\/li>\n<li data-mce-word-list=\"1\">Equipment maintenance<\/li>\n<li data-mce-word-list=\"1\">Data archiving and retention<\/li>\n<\/ul>\n<p class=\"greenfill\" style=\"text-align: justify;\"><strong>Workshop Programme<\/strong><\/p>\n<table>\n<tbody>\n<tr>\n<td><strong>Time<\/strong><\/td>\n<td><strong>Topic<\/strong><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Saturday<\/td>\n<\/tr>\n<tr>\n<td>09:00 \u2013 11:00<\/td>\n<td>Welcome address<\/p>\n<p>Training objectives and orientation<\/p>\n<p>Ground Rules<\/td>\n<\/tr>\n<tr>\n<td>11:00 \u2013 11:30<\/td>\n<td>Tea and coffee<\/td>\n<\/tr>\n<tr>\n<td>11:30 \u2013 12:00<\/td>\n<td>GCLP implementation successes and challenges<\/td>\n<\/tr>\n<tr>\n<td>12:00 \u2013 13:00<\/td>\n<td>Discussions<\/td>\n<\/tr>\n<tr>\n<td>13:00 \u2013 13:30<\/td>\n<td>Lunch<\/td>\n<\/tr>\n<tr>\n<td>13:30 \u2013 14:30<\/td>\n<td>Questions &amp; Answers<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Sunday<\/td>\n<\/tr>\n<tr>\n<td>09:00 \u2013 11:00<\/td>\n<td>Process Control:<\/p>\n<p>Samples management<\/p>\n<p>Case studies and discussion<\/td>\n<\/tr>\n<tr>\n<td>11:00 \u2013 11:30<\/td>\n<td>Tea break<\/td>\n<\/tr>\n<tr>\n<td>11:30 \u2013 13:00<\/td>\n<td>Process Control:<\/p>\n<p>Quality control<\/p>\n<p>Method validation<\/p>\n<p>Case studies and discussions<\/td>\n<\/tr>\n<tr>\n<td>13:00 \u2013 13:30<\/td>\n<td>Lunch<\/td>\n<\/tr>\n<tr>\n<td>13:30 \u2013 15:00<\/td>\n<td>EQAS &amp; audits case studies<\/p>\n<p>Internal and external quality control<\/p>\n<p>Discussion &#8211; group activity<\/td>\n<\/tr>\n<tr>\n<td>15:30\u00a0 &#8211; 16:30<\/td>\n<td>Demonstration of the use of temperature monitor<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Monday<\/td>\n<\/tr>\n<tr>\n<td>9:00 \u2013 9:30<\/td>\n<td>Recapitulation of previous days<\/td>\n<\/tr>\n<tr>\n<td>9:30 \u2013 10:30<\/td>\n<td>Data and information management<\/p>\n<p>Case studies<\/td>\n<\/tr>\n<tr>\n<td>10:30 \u2013 11:00<\/td>\n<td>Group activity and discussion<\/td>\n<\/tr>\n<tr>\n<td>11:00 \u2013 11:30<\/td>\n<td>Tea break<\/td>\n<\/tr>\n<tr>\n<td>11:30 \u2013 13:00<\/td>\n<td>Facilities, safety and security<\/p>\n<p>Equipment and inventory<\/p>\n<p>Group activity &amp; presentations<\/td>\n<\/tr>\n<tr>\n<td>13:00 \u2013 13:30<\/td>\n<td>Lunch<\/td>\n<\/tr>\n<tr>\n<td>13:30 \u2013 15:00<\/td>\n<td>Personnel, Documentation<\/p>\n<p>Free discussion<\/td>\n<\/tr>\n<tr>\n<td>15:00 \u2013 15:30<\/td>\n<td>Coffee break<\/td>\n<\/tr>\n<tr>\n<td>15:30 \u2013 17:30<\/td>\n<td>Course Evaluation<\/p>\n<p>Closing ceremony<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p style=\"text-align: justify;\"><strong>\u00a0<\/strong><\/p>\n<p style=\"text-align: justify;\"><strong>Instruction Methods<\/strong><\/p>\n<p style=\"text-align: justify;\">This workshop is a hands-on training activity with various interactive instructional techniques. There will be brief presentations, with many small group teaching, discussions and presentations. There will be many homework assignments and groups presentations. Case studies and Sharing experience session will be included in the workshop.<\/p>\n<p class=\"greenfill\" style=\"text-align: justify;\"><strong>Who Should Attend<\/strong><\/p>\n<p style=\"text-align: justify;\">The target attendees are medical and health professionals, microbiologists, pathologists, laboratory directors, managers, and technologists. QA\/QC officers and Quality officers, and managers, as well as other scientists who share an interest in the field of clinical trials and experimental research.<\/p>\n<p class=\"greenfill\" style=\"text-align: justify;\"><strong>Workshop Duration<\/strong><\/p>\n<p style=\"text-align: justify;\">It is a three-day intensive workshop.<\/p>\n<p class=\"greenfill\" style=\"text-align: justify;\"><strong>Workshop Coordinator<\/strong><\/p>\n<p>A group of experts will facilitate the workshop<\/p>\n<p class=\"greenfill\" style=\"text-align: justify;\"><strong>How will the assessment be done?<\/strong><\/p>\n<ul style=\"text-align: justify;\">\n<li data-mce-word-list=\"1\">Pre-workshop MCQs to assess the prior participants&#8217; basic knowledge<\/li>\n<li data-mce-word-list=\"1\">Interactive sessions<\/li>\n<li data-mce-word-list=\"1\">Post-workshop MCQs to assess the acquired knowledge and certificate will be awarded after achieving the minimum pass score.<\/li>\n<li data-mce-word-list=\"1\">Those who fail to achieve this score will be offered a second attempt to take the following workshop&#8217;s post-workshop assessment.<\/li>\n<\/ul>\n<p class=\"greenfill\" style=\"text-align: justify;\"><strong>Workshop Evaluation<\/strong><\/p>\n<ul style=\"text-align: justify;\">\n<li data-mce-word-list=\"1\">Oral and written participants and workshop facilitators feedback will be obtained<\/li>\n<\/ul>\n<p class=\"greenfill\" style=\"text-align: justify;\"><strong>How to Apply<\/strong><\/p>\n<p style=\"text-align: justify;\">To apply for the course, please complete the\u00a0<a href=\"https:\/\/www.mycetoma.edu.sd\/workshop-registration\">Online Application Form<\/a><\/p>\n<p class=\"greenfill\" style=\"text-align: justify;\"><strong>CPD Credits<\/strong><\/p>\n<p style=\"text-align: justify;\">5 CPD credits<\/p>\n<p class=\"greenfill\" style=\"text-align: justify;\"><strong>Instruction Language<\/strong><\/p>\n<p style=\"text-align: justify;\">English<\/p>\n<p class=\"greenfill\" style=\"text-align: justify;\"><strong>Workshop Dates<\/strong><\/p>\n<p style=\"text-align: justify;\">Three times per year<\/p>\n<p class=\"greenfill\" style=\"text-align: justify;\"><strong>Teaching Materials<\/strong><\/p>\n<ul>\n<li style=\"text-align: justify;\" data-mce-word-list=\"1\">British Association of Research Quality Assurance (BARQA) (2003) Good Clinical Laboratory Practice Version 1 (available as World Health Organization (2009) Good Clinical Laboratory Practice) 19 March 2015.<\/li>\n<li style=\"text-align: justify;\" data-mce-word-list=\"1\">European Medicines Agency (EMA) Good Laboratory Practice Compliance: 19 March 2015<\/li>\n<li style=\"text-align: justify;\" data-mce-word-list=\"1\">Sarzotti-Kelsoe M, Cox J, Cleland N, Denny T, Hural J, Needham L, et al. (2009) Evaluation and Recommendations on Good Clinical Laboratory Practice Guidelines for Phase I\u2013III Clinical Trials. PLoS Med 6(5): e1000067.<\/li>\n<li style=\"text-align: justify;\" data-mce-word-list=\"1\">World Health Organization (2009)\u00a0<a href=\"https:\/\/www.who.int\/tdr\/publications\/documents\/gclp-web.pdf\" target=\"_blank\" rel=\"noopener\">https:\/\/www.who.int\/tdr\/publications\/documents\/gclp-web.pdf<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>he Mycetoma Research Centre University of Khartoum WHO Collaborating Centre on Mycetoma \u00a0The Mycetoma Research and Development Arcade Workshop Overview Good clinical laboratory practice (GCLP) workshop provides and discusses the quality system principles and procedures that the clinical laboratories should carry out to provide consistent, reproducible, reliable laboratory results. This workshop will offer unique, comprehensive [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-4054","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/mycetoma.edu.sd\/index.php?rest_route=\/wp\/v2\/pages\/4054","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mycetoma.edu.sd\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/mycetoma.edu.sd\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/mycetoma.edu.sd\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/mycetoma.edu.sd\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=4054"}],"version-history":[{"count":5,"href":"https:\/\/mycetoma.edu.sd\/index.php?rest_route=\/wp\/v2\/pages\/4054\/revisions"}],"predecessor-version":[{"id":5103,"href":"https:\/\/mycetoma.edu.sd\/index.php?rest_route=\/wp\/v2\/pages\/4054\/revisions\/5103"}],"wp:attachment":[{"href":"https:\/\/mycetoma.edu.sd\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4054"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}