{"id":45703,"date":"2022-06-30T17:01:42","date_gmt":"2022-06-30T15:01:42","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/project-management-for-fda-regulated-companies-webinar-researchandmarkets-com\/"},"modified":"2022-06-30T17:01:42","modified_gmt":"2022-06-30T15:01:42","slug":"project-management-for-fda-regulated-companies-webinar-researchandmarkets-com","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/project-management-for-fda-regulated-companies-webinar-researchandmarkets-com\/","title":{"rendered":"Project Management for FDA-Regulated Companies Webinar &#8211; ResearchAndMarkets.com"},"content":{"rendered":"<div>\n<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/4899564\/project-management-for-fda-regulated-companies?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=thqlv3&amp;utm_campaign=1720389+-+Project+Management+for+FDA-Regulated+Companies+Webinar&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">&#8220;Project Management for FDA-Regulated Companies&#8221;<\/a> webinar has been added to <strong>ResearchAndMarkets.com&#8217;s<\/strong> offering.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220630005664\/en\/1502383\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220630005664\/en\/1502383\/21\/logo.jpg\"><\/a><\/p>\n<p>\nThis webinar will provide valuable guidance to regulated companies in development and implementation of new Lean Project Management Planning concepts including some Agile principles, for new product development, regulatory compliance audit responses, proof of `progress against plan`, and other activities requiring a planned documented rationale.\n<\/p>\n<p>\nThree of the most common tools will be discussed. `Hit the ground running` with one very simple approach using common Excel- or Word-type PC applications programs. Learn how regular use of a few simple but powerful tools will virtually eliminate `firefighting` in a new project.\n<\/p>\n<p>\nThe FDA expects companies to manage projects formally, with a written plan &#8212; to include regulatory requirements, design and\/or change control, with consideration of all applicable standards, and to demonstrate `progress against plan`. The EU MDD and their notified bodies are no different.\n<\/p>\n<p>\nHow can this be done from a project&#8217;s inception? How can lean principles be incorporated from project inception? What is `failing fast` in the `build, measure, learn, re-evaluate \/ decide loop`? Can Agile principles mesh with FDA&#8217;s documentation requirements? How can a Project Leader or Project Manager ensure critical elements are not omitted until late in the project when disaster looms? How to gain management support for the Milestones, Tasks, Timelines?\n<\/p>\n<p>\nAttend this training to understand how one can reduce scheduling uncertainty, aid project team communication, prevent incomplete projects when time is running out, decrease product liability, assist in company-wide cost reduction efforts, with less chance of recalls, and an improved bottom line.\n<\/p>\n<p>\n<strong>Who Should Attend:<\/strong>\n<\/p>\n<p>\nThis webinar will provide valuable assistance to all FDA-regulated companies that need an easy to implement, easy to explain, and repeatable methodology. It will provide the basic tools to assist in-house personnel to be trained in project management tools and techniques, targeted specifically to the regulated medical products industries, under cGMP and EU MDD\/CE-marking compliance.\n<\/p>\n<p>\nIt will discuss and provide examples of the most common project management tools and provide a major example for immediate use. This applies to companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.\n<\/p>\n<p>\n<strong>The employees who will benefit include:<\/strong>\n<\/p>\n<ul>\n<li>\nProject Managers\n<\/li>\n<li>\nSenior management\n<\/li>\n<li>\nRegulatory affairs\n<\/li>\n<li>\nQuality Assurance\/QAE\n<\/li>\n<li>\nProduction\n<\/li>\n<li>\nR&amp;D and Engineering\n<\/li>\n<\/ul>\n<p>\n<strong>Key Topics Covered:<\/strong>\n<\/p>\n<ul>\n<li>\nMeet key requirements of the CGMPs\/ISO; Quality Plans\n<\/li>\n<li>\n`Failing Fast` Formal Lean Project Management\n<\/li>\n<li>\nThe Three Most Common Tools &#8211; Gantt, CPM, PERT\n<\/li>\n<li>\nWork breakdown Structure, Milestones, Tasks\n<\/li>\n<li>\nDrive Success or Failure Fast; Fast Cycle\/Agile Principles\n<\/li>\n<li>\nThe Build, Measure, Learn, Re-evaluate Loop\n<\/li>\n<li>\nExample: A Suggested New Product Template\n<\/li>\n<li>\nOne Major, But Often Neglected, Use\n<\/li>\n<\/ul>\n<p>\n<strong>Speakers<\/strong>\n<\/p>\n<p>\nJohn E. Lincoln, consultant, has successfully designed, written over 50 ISO 14971-compliant Risk Management Files \/ Reports, including FMECA and FTA analysis, many in response to FDA 483 observation, which have subsequently passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development \/ design control projects; with over 24 years of experience, primarily in the medical device industry &#8211; working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco \/ Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of cGMP.\n<\/p>\n<p>\nFor more information about this webinar visit <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/4899564\/project-management-for-fda-regulated-companies?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=thqlv3&amp;utm_campaign=1720389+-+Project+Management+for+FDA-Regulated+Companies+Webinar&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.researchandmarkets.com\/r\/letf45<\/a>\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nResearchAndMarkets.com<br \/>\n<br \/>Laura Wood, Senior Press Manager<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#97;&#x69;&#x6c;&#116;&#x6f;&#58;p&#x72;&#101;s&#x73;&#64;r&#x65;&#115;e&#x61;&#114;&#x63;&#x68;&#97;&#x6e;&#x64;&#109;&#x61;&#114;k&#x65;&#116;s&#x2e;&#99;o&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#x70;&#x72;&#x65;&#115;&#115;&#64;r&#x65;&#x73;&#x65;&#x61;&#114;&#99;ha&#x6e;&#x64;&#x6d;&#97;&#114;&#107;et&#x73;&#x2e;&#x63;&#111;&#109;<\/a><\/p>\n<p>For E.S.T Office Hours Call 1-917-300-0470<br \/>\n<br \/>For U.S.\/CAN Toll Free Call 1-800-526-8630<br \/>\n<br \/>For GMT Office Hours Call +353-1-416-8900\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Project Management for FDA-Regulated Companies&#8221; webinar has been added to ResearchAndMarkets.com&#8217;s offering. This webinar will provide valuable guidance to regulated companies in development and implementation of new Lean Project Management Planning concepts including some Agile principles, for new product development, regulatory compliance audit responses, proof of `progress against plan`, and other activities requiring &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/project-management-for-fda-regulated-companies-webinar-researchandmarkets-com\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":["entry","post","publish","author-business","post-45703","format-standard","category-industry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Project Management for FDA-Regulated Companies Webinar - ResearchAndMarkets.com - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/project-management-for-fda-regulated-companies-webinar-researchandmarkets-com\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Project Management for FDA-Regulated Companies Webinar - ResearchAndMarkets.com - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Project Management for FDA-Regulated Companies&#8221; webinar has been added to ResearchAndMarkets.com&#8217;s offering. 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